7 RESDOOIST GRIFOLS [verton: "(50 most Recent fecive: CURRENT Diagnostic Gifs. SA [Status: Effective [Uncontrolled Copy (Class: | Genérico Requlado [Effective date: [08-Feb-2019 Manual erytra efiexis 3. Select TeamViewer option. 4, Ifrequested, type a valid usemame and password in order to acess the Intemet. Figure 421. Internet access identification request 8. The main client application window will then be displayed, providing a connection ID and password. Figure 422. Connection 1D and password provided by the client application 13.15 erytra eflexis®- LIS connection The connection of erytra elfexis® to the L/S is established through Diana System (DianaServer program) and Diana System names (tests, microtubes....) will be used. Enytra effexis*/Diana System to LIS communication has been implemented in accordance with the CLSI LISO1-A2 and CLSI LIS02-A2 standards (Formerly ASTM E1381-02 and ASTM E1394- 97, respectively). CLSI LISO2-A2 standard establishes a format for the messages that must be ‘sent from the LIS to the instrument and vice versa, but does not specify the way in which they must be sent. CLSI LISO1-A2 standard describes the way in which messages should be physically sent to the LIS, but does not specify a format. ‘Thus, erytra efiexis® can communicate with the L/S using 3 different exchange types: + Using serial data exchange, where the computers serial channel is used. + By saving messages in filas on local or remote disk units that can be accessed by both LIS and erytra efiexis®. + By using TCP/P protocol in a network domain Diana System Connectivity (DSC) is the erytra eflexi” software section that translatesfinks erytra eflexis® and Diana System names. ‘Conflental Information. I's not allowed the Total or paral reproduction of ths document without prior authorization. Print date: [os-Feb-2018 [Page _ 428 of 451:_ TREC GRIFOLS [aesion* leo: tostreste ERSave CURRENT Diagnosis Gils. SA_[Status: [Effective Purpose: [Uncontrolled Copy =| Genérico Requlado Effective date: [08-Feb-2019 service Manual ervira efiexis DianaServer will temporarily store the requests sent by the LIS in LisTests.def fle. When result has to be transmitted to the LIS: ‘© bi-directional transmission: the existing record in the list is updated. © _uni-directionalre-send transmission; a new record is created in the list. with the information to be transmitted and, once the transmission has been completed successfully, DianaServer deletes the transmitted record 13.15.41 DianaServer program DianaServer is the Diana System program that communicates with the LIS. In order to use it, it should be previously enabled by ticking the corresponding checkbox in Diana O. program (Listas.exe) located in E:\datalSistemaDiana > Program configuration — Others tab (disabled by default). As the communication between DianaServer and erytra® software uses IP protocol, the IP Address and Port fields of the PC where DianaServer is going to be used should also be configured in this window (default values are localhost and 8070, respectively). Ober [verte be Seeesazen “Tenancies pa ete | P beeme uncon. oxy ce x) x! a SNS aC STO IT ‘When executing DianaServer, an icon appears in the bottom-right edge of the taskbar for those modes where the taskbar is available (such as Maintenance Modé leg? Figure 424 DianaServer eon Right clicking with the mouse brings up a context menu with the options Configuration and ‘Close. Clicking on the configuration option opens following window: ‘Confidential Information. I's not allowed the total or partal reproduction ofthis document without prior authorization. Print date: [os-Feb-2018 [Page _ 429 of 45%GRIFOLS Referenci REGD-OOTSO7E Version: 5.0; Most-Recent, Effective; CURRENT. Oiagnoste Gics.SA_[Status: effective Purpose Uncontroed Cop, Class: | Genérico Requiado_ [Effective date: [08-Feb-2019 Title:_| Service Manual ervtra eflexis. a = FH sees asa} x] x| Figure 425 DianaServer configuration window ‘The DianaServer port to be used should be indicated in the Diana Server Port field on top of the window, and must match with the Port number indicated in Diana O. configuration (default value is 8070). As for the communication between DianaServerlerytra eflexis® and LIS, the Configuraion option allows selecting the communication mode between both systems (Seria! Port, File or TCP/IP mode with their corresponding parameters) and the communication timeout. Bi-directiona/Uni- Tmt 1 ° P BSitvesion Number — 5 ; ; ‘Sooctme” Nunes; f+ —yyyawobumuss —vrrnmvooHenness Table 11.Message header record ~ Sending of resus PATIENT INFORMATION RECORD SI Hee Type tengey Vole tectonan Vae(unkrecional) Comments moyen Me # 2 Number itin iS Number win iS Sequence Nanter Number Under Number in ec irPaient to Practce-Assigned net cocoa — yy Unset Patient PatentiD aval, Sino Be soot Laborto-Assined raeorAssoned yt Unde, pateris Number Nu Unt LastnanetFist Lastranerist —Exely fomencae, —‘amatiee Senos Patertnane mm 1m, name or ‘name or ‘sent from intchSumcrte — intatancerae is Mater tien uy unt ae ammcce = 887 vv on paionse Tot ueory Sat Rast —— errs ™ ‘Null! Undet. Recard ends Patient Address ——Null-—-Undet at. pt Facevoctes Mut Uncet incre, Paton Teophone rie ‘Number Nut Unease ‘data is sent, tonne Prien uy unset tee co Specal ies Nal Unde, rat fo Seegirece Nat Ghat, one Confidential Information. ffs not alowed the Total or partial reproduction ofthis document without prior authorization, Print date: [o8-Feb-2019, [Page 443 of 451GRIFOLS [fasion [so woscRece erecwe: CURRENT Diagnostic Grits, SA [Status: [Effective (Purpose: [Uncontrolled Copy Glass: | Genérico Requlado Effective date: 06-Feb-2019 Title: [Service Manual ervira eflexis ‘ASTM Fiold Type Length Value bidirectional) Value unidirectional) Comments Pationt Height © Null-—-Undet. emograhic Patient Weight Null’ Unde. ate samt Patient's Knonn or Suspected ‘Nut Undet Diagnosis Patient Active reich Nut Under Patents Diet ——-Null_—-Undet. Practice Field pede Nui Undet Practice Field teeta rr ‘Null Undet Admission and jerssonen, Ml Undo Admission Status Null Undet Nature of Aterative Diagnostic Code end Null Unde. Classifiers Atemative Diagnostic Code and — Null Unde ‘Classifcaton Patient Religion —Null—-Undef. Martel Status. = Null’ ~—Undef Isolation Status Null’ Undef. ‘Language Nut Under Hospital Sevice Null Unde Hospital nsttuvon —Null—Und. ‘Dosage Category Null Under. Table 112.Patient information record — Sending of results TEST ORDER RECORD ‘ASTM Field Type Length Value (bidirectional) Value unidirectional) Comments Record typeiD Text. = ° ° ony ere 0 urdgsert ate ine — anne ‘Number within Patient Numberwithin Patent essage Sequence Number Number Undef. rt rls a ‘irene Foner sonewn ho eas sont er Semple BC (non Sample BC (non atch) "Ximatch) spactren Text Unde sompie BC*Donor 8C Sample BC'Donor BC (match) (match) ato unser ey not ola (oe Noe) cawtedisiet Shares ‘caroveet ofa to Instrument Tet 7 Batoh number-0 (one Batch mumber-0 (eee "may mtb ‘Specimen 1D 0 0 cose ret contaied ‘eevee ats Stem vtomepenre Dats sese ‘Confidential Information. is not allowed the Total or paral reproduction ofthis document without prior authorization, Print d [08-Feb-2019 [Pase 444 of 451GRIFOLS Version” [50 woseRessre efecive| CURRENT Diagnostic Grfols. SA. [ Status: [Effective (Purpose: Uncontrolled Copy ‘Genérico Regulado_ [Effective date: [08-Feb-2019 [Service Manual erytra eflexis ASTM Field Type Length Value (bidirectional) Value (unidirectional) “Comments or sen mood ‘estes rame(Diana Test nameOiana UnversltestiO Text Unde. “SelonTomplte Syston) *Temolat ae rane words Greco as pronly «Al Undo Rs Rs route, § erected as rat RequestedOrered 1 aquesteOrered yj Und, YYYYMMDDHMMSS _YYYYMINDDHNSS ‘Specimen Collection ener Coton ug Ud. cotectontnd Time Nil Unde Cotecson votre, Nuit Und. CotccorD” Nal Un ston Godel Under DangorCote ihn igs Sse one aan ae, tone mumter'S0s0f #Becheumbor8Csef Sots # Retevent clic ‘agers eons roars triomston” Nil Ute Sear une, anearsuseg, Separtedty* — sapartedby** shea an os aren Sent eee ome = pa Date/Time Specimen Time Specimen gy Una. ‘Specimen Descriptor Null ~—_Undef. Srcarng Psean Nal Un nyicens Telephone Number aay Uden UsefotiNumber) —Null_—_Undet. Userreinumber? Null Unde ‘eran ret tran Fett uy net Lateran et Boston’ Ftd uy Und Datene Pests ‘eporedoriast™ ul Unde ‘need instore Charge ‘Sitemeter Nal Und Sytem Insrament Seaton uy Unde WADIANAYS (ERY REPORT'OOIERY c ret F F econ Fe Nal Ure pty re sped emer yy Nal Un a Nosocomial Infection Null Undet ‘Confidential Information. I's not allowed the (otal or paral reproduction ofthis document without prior authorization. Print date: [os-Feb-2018 [Page _ 445 of 457GRIFOLS weston" [en oseRecre EREaVE: CURRENT Dagroste Gris SA [Status: _[Eective Purpose: [Uncontrolled Cop ‘Genérico Reaulado Effective date: [06-Feb-2019 [Service Manual ervira eflexis ‘ASTM Field Type Length Value (bidirectional) Value (unidirectional) Comments Fig ‘Specimen Service Null Undet Specimen Institution Null _—_-Undet. Table 113.Test order record Sending of results RESULT RECORD ASTM Field Type Length Value (bidirectional) Value (unidirectional) Comments Record typeI Text’ 7 R R Number within Order Number within Order Record Record Test name(Diana Test name(Diana UniversaltestiD ——Null-~—Undef.——System)*Template System) Tempiate Sequence Number Number Undof. telacr Results included in Results included in Mosse Vato Text Undet tempiate, template, nett separated by separated by" Tempialte felts, in the Template fields, inthe ee Text Under, _SaMeorderofthe same order ofthe results, separated by results, separated by Reference Ranges Null_-—_Undet. Roetennormel ul Unde. N " Nature of Abnormality Testing Nut Unde Result Status Null Under. F F Date of Change in Instrument Normative Values or Mull Undet Units Operator eae Text Undet. _Usemame of sender Username of sender Date/Time Test Date / Same asin pid, Fe, Undet, YYYvimpoHeMMSS YYYYHMODHHMMSs Some 28 Date/Time Test Date / metas Gate! Undet, YYYYMMOOHFMMSS _YYYYMMDDHHMMSS Insirument Fg i ee ‘Null Under. WADIANA's "ERY REPORT*OOO"ERY Table 114.Resuit record ~ Sending of results MESSAGE TERMINATOR RECORD ‘ASTM Fiold Type Length Value (bidirectional) Value (unidirectional) Comments Record ype ID Text. «ot L c Sequence Number Number 1 1 1 Termination Code Text = Nn Nn Table 118.Message terminator record ~ Sending of results Examples: Bidirectional: HINS&|IWADIANA"0510%ERY|I/P[1]2011 1011113713, Pi1]8814224 i]LastName*FirstNamel|19000101|U] (1]861422 1110008-0]***DGWOtA gruNEryrapn|R/20111007 153316 WADIANA“0S10°ERYF| RiiPMDGWOTA gru*Eyta.pln|s*s- SJAC.AGG"X_IGG"XX°A" IPOS IAC||N|F|ADMIN]20111007153318\20" 11007 153547]WADIANANOS10"E RY! 2\88367744)\LastName*FirstName||19000101|U {1]88367744)0008-0}"™*DGWO1A gruEnytra pin|RI20111007152102IIlII WADIANA*0510°ERYIF] RI1|DGWO1A.gru'Enyta.pin|**AC.IGG"X_IGG"X X*ANPos IACIIN|F||ADMIN|20 1 1007152102/20 141007 159699]WADIANA"05 10°ERY| LIN Confidential infarmation. Its not aloed' the total or partlal reproduction ofthis document without prior authorization. Print date: Toe-Fee-2019 [Page 46 of 451GRIFOLS [estn: —[s0: nostro Eexwe: CURRENT Dagnostc Ge. SA. [Status: ——[eMiecve Purpose! | Uncontraled Copy [Class] Genérico Reaulado Effective date: [08-Feb-2019 TTitie:_[Service Manual erytra eflexis Unidirectional: H}*aiREPORT*ODO*ERYrti20191214174028 Pris oft}s2)0000- o}#DGWVO3A.gru"Enfa.cn|RI20111214144640)I40°0210Z9480005"021128490004"7135091200000 00358IIIIIII| REPORT*OOO*ERY|F| Rit} GINO grrr. pi NFIADMIN[2011121414e54020111216144618|REPORT*OOOERY] uti ‘Confidential information. Irs not allowed the total or partial reproduction ofthis document without prior authorization. Print da [os-Fe5-2019 [Page 447 of 451REGD-O0T074 GRIFOLS '5.0; Most-Recent: Effective, CURRENT Diagnostic Grfals SA. [Effective Purpose: Uncontrolled Cop} [Classi] Genérico Requlado Effective date: [08-Feb-2019 Title: [Service Manual ervtra eflexis 13.16.6 erytra eflexis® — LIS errors In this section, erytra eflexis® and LIS communication errors are listed. Following tables include Diana System errors and erytra eflexis ® software errors related to LIS communication, eae —] arene cae Tat fomat enor | Road over wars spate cratenarga | Head enor i inet be noone Tar (Wosttorma #2 | not begin with "Ht Tostfomat ror 2 [Evora Paani NojateriD Test format error | Test: Not ero fs Massaoe. error: fest: No sf Message [aostfomaterort | Tes No pec ald (ASTM-1394 Host format error #6 | Test: No test name fields standard) Host format error #7 | Error, an O field before a P field Hest format ert [Ero anf fob nO Tad Host fomat ror | Reals Not enough fl i eS Poattie anare) EXan We OCTUPRTT OUY.ORT Gn ak wi ewortna deen Fle Benge te BC MPDATTOUTDAT hasbeen SRRROE communication iendtfoesbe Sa ero Teele over | INDAT fie can robe coed Teste oor #8 | OUT.DAT le an rotbe dla ‘TCPIIP. Reomotshestret [US sever ls ot ready when jeg to esbish communication | ready ‘communication with DianaServer. cus Ts oar | Tne chon ig Fae Host sea eror #2 cred fenerecehed Host eaa oor | eoect rae caved, SK aut Host sora evor | Nether ETS or ETXteing caved ie Fane ost seralerord® | Fane recehed wie ecu setaloc | Hestseaeror | Fane eoaked wih wong ec Tern Host serial error #7__| Frame received with wrong ID ‘communication ee os Cnteova enor ag | Conary ore aS BS Sonnets wl nal mepara Test eoaleror_| Undetermined err Host serial error #10 | Frame sent 6 times and returned by LIS as faulty (NAK) Tost sofalevor 1 | ENG ceed wil esting conmancaion Host erialeror | Stange character recied we esablishng crmnzaton Hostsoraleror #8 [ECT isa Table 176 Diana System errors related to LIS communication Confidential Information. [is not allowed the Total or partial reproduction ofthis document without prior authorization. Print date: [08-Feb-2018 age 448 of 45