Qualitätsring Medizinischer Software
Transcription
Qualitätsring Medizinischer Software
Integration of medical instruments GDT 3.0 Device data volume Interface description for systemindependent data transfer between medical information systems and medical instruments © QMS Qualitätsring Medizinische Software e. V. Düsseldorf, 2013 Version: 3.0 Release: 1.0 Date: 10/01/2013 Status: Released Version 3.0 Release 1.0 Author Ralf Franke (Head of working group GDT) Editors Silke Hochheim, Ralf Franke Contributions of: QMS Arbeitskreis BDT/GDT/LDT and additional contributions: Arzt & Praxis GmbH, Awinta GmbH, CareFusion GmbH, DGN Deutsches Gesundheitsnetz Service GmbH, HABEL GmbH & Co. KG, Kassenärztliche Bundesvereinigung, ktberger-consulting, medatixx GmbH & Co. KG, Reinhold Mainz Status Released Released at / by 10/01/2013 / Qualitätsring Medizinische Software e.V. Coordinated with Arbeitskreis GDT/BDT des QMS e.V. Änderungshistorie: Version Date Updated by Update reason / description 2.99.3.0.1 11/07/2011 Ralf Franke First draft 2.99.3.0.2 11/09/2011 Ralf Franke Supplements from feedback 2.99.3.0.3 11/10/2011 Ralf Franke • FK 9106 changed into in FK 9206 (GDT V 2.1) • Extension FK 8402 (according to proposal) • New object „ArztIdent“ 2.99.3.0.4 01/16/2012 Ralf Franke Revision 2.99.3.0.5 02/03/2012 Ralf Franke Extension/Revision according to working group meeting BDT/GDT at 17.01.2012 2.99.3.0.6 03/01/2012 Ralf Franke Update of the QMS e.V. contact data 2.99.3.0.7 03/28/2012 Ralf Franke Update of comments 2.99.3.0.8 05/20/2012 Ralf Franke Inclusion of legwork/contributions of: ktberger-consulting, Arzt & Praxis GmbH und DGN Deutsches Gesundheitsnetz Service GmbH 2.99.3.0.9 08/06/2012 Ralf Franke • Update comments • Revision box-chart • Addition chapter Workflow • New record type 6303 „Cancellation of an order“ 2.99.3.1 08/30/2012 Silke Hochheim Editorial adaptation to new QMS-layout 2.99.3.2 09/24/2012 Ralf Franke Addition/Revision according to working group meeting BDT/GDT at 04.09.2012 3.0 10/15/2012 Ralf Franke Pre-release for comment period 3.0 01/17/2013 Ralf Franke Consideration of contributions from the comment period GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 2 von 57 Date: 10/01/2013 Version Date Updated by Update reason / description 3.0 01/31/2013 Ralf Franke Final version pre-release 3.0 Release 1 07/01/2013 Ralf Franke Editorial changes: Revision of example files, graphics, typing errors 3.0 Release 1 10/01/2013 Ralf Franke Final version for publication on the homepage of the Qualitätsring Medizinische Software e.V. Preface Only through the dedicated work of the Qualitätsring Medizinische Software e.V (hereinafter called QMS) has the present GDT data record description become possible. Anyone who wants to benefit from the results is therefore invited and advised to collaborate in consensual studies. Unfortunately, faulty and non-certified versions of the GDT interfaces have repeatedly emerged in the past under the guise of a “GDT interface” which might weaken the goal of a standardized data transfer between systems to ultimately undermine the efforts of the QMS for quality standards. We have therefore decided to list those faulty implementations and their publishers on the association’s internal bulletin boards to reveal them only internally for now. This action is accompanied by a letter of the QMS management to the responsible company which contains the demand to submit to the standards and adapt the software or not to use the term "GDT interface" any longer. Hence: Become a member, contribute and become certified! (www.qms-standards.de) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 3 von 57 Date: 10/01/2013 Inhaltsverzeichnis 1 INTRODUCTION 7 1.1 General remarks .............................................................................................................................7 1.2 Definition of terms ..........................................................................................................................7 1.3 Communication ..............................................................................................................................8 1.4 Labeling of the interface properties .............................................................................................8 1.4.1 General remarks .....................................................................................................................8 1.4.2 Minimum requirement for PVS and DEVICE ..........................................................................8 1.4.3 Labeling for PVS .....................................................................................................................8 1.4.4 Labeling for DEVICE ..............................................................................................................9 1.4.5 Examples for possible combinations PVS / DEVICE .............................................................9 2 INTERFACE DESCRIPTION 9 2.1 Identification of the components (GDT-ID) ..................................................................................9 2.2 Character set ..................................................................................................................................9 2.3 Communication via file ................................................................................................................10 2.3.1 File names ............................................................................................................................10 2.3.2 Directory ...............................................................................................................................10 2.4 Communication via serial interface............................................................................................11 2.4.1 Hardware ..............................................................................................................................11 2.4.2 Procedure of communication ................................................................................................12 2.5 Examples to the procedure .........................................................................................................12 2.6 Annotated example files ..............................................................................................................15 2.6.1 Structure of a GDT line: ........................................................................................................15 2.6.2 Example file “Transmission of master data” (Stammdaten übermitteln) (6301) ...................15 2.6.3 Example file “Transmission of examination data” (Daten einer Untersuchung übermitteln) (6310) 16 3 CODE PAGE 17 3.1 Definition of record types: Request master data (Stammdaten anfordern) „6300“ ..............19 3.2 Definition of record types: Transmission of master data (Stammdaten übermitteln) „6301“19 3.3 Definition of record types: Request new examination (Neue Untersuchung anfordern) „6302“ ....................................................................................................................................................19 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 4 von 57 Date: 10/01/2013 3.4 Definition of record types: Cancel requested examination (Angeforderte Untersuchung stornieren) „6303“ ................................................................................................................................20 3.5 Definition of record types: Transmission of examination data (Daten einer Untersuchung übermitteln) „6310“ ..............................................................................................................................21 3.6 Definition of record types: Display data of an examination (Daten einer Untersuchung zeigen) „6311“ .......................................................................................................................................22 4 FIELD CHART 23 5 CHART OF RULES 29 6 ANNEX 29 6.1 Annex A: Block format for serial data transmission, including examples .............................29 6.1.1 Transmission protocol ..........................................................................................................29 6.1.2 Transmission block ...............................................................................................................29 6.1.3 Meaning of the respective fields ...........................................................................................30 6.1.4 Examples ..............................................................................................................................30 6.2 Annex B: Device and process specific characteristic map „8402“ ........................................35 6.3 Annex C: Transmission of measurement data ..........................................................................40 6.4 Annex D: Building Blocks / Objects ...........................................................................................43 6.5 Example files “Best Practice“ .....................................................................................................44 6.5.1 Request master data “6300” (DEVICE to PVS)....................................................................44 6.5.2 Transmission of master data “6301” (PVS to DEVICE) .......................................................44 6.5.3 Request new examination “6302” (PVS to DEVICE) ...........................................................44 6.5.4 Transmission of examination data “6310” (DEVICE to PVS) ...............................................45 6.5.5 Display data of an examination “6311” (PVS to DEVICE) ....................................................46 6.5.6 Appointment request “6302” (PVS to DEVICE) ....................................................................46 6.5.7 Referral to specialist “6302” (PVS to DEVICE) ....................................................................46 6.5.8 Hospitalization “6302” (PVS to DEVICE) ..............................................................................47 6.5.9 Transmission of emergency data “6302” (PVS to DEVICE) .................................................48 7 ILLUSTRATION OF THE WORKFLOWS 49 7.1 Basic-Workflow ............................................................................................................................49 7.1.1 Requirements .......................................................................................................................49 7.1.2 Illustration of results data ......................................................................................................50 7.2 Storage of patient master data ...................................................................................................50 7.2.1 Single or direct transmission of data ....................................................................................51 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 5 von 57 Date: 10/01/2013 7.2.2 Batch transmission of master data .......................................................................................51 7.3 Simple form of a GDT request ....................................................................................................52 7.3.1 Result ....................................................................................................................................53 7.4 Asynchronous communication ..................................................................................................54 7.5 Asynchronous communication in equipment sharing .............................................................55 7.5.1 Process .................................................................................................................................56 7.5.2 Extensions of the GDT .........................................................................................................57 7.5.3 Necessity of a definition for transmission paths ...................................................................57 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 6 von 57 Date: 10/01/2013 1 Introduction 1.1 General remarks The present interface description was developed by the QMS (Qualitätsring Medizinische Software e.V) to define a standardized interface between medical information systems and medical devices. The interface (Geräte-Daten-Träger – GDT device data volume) is therefore written in a neutral form and can be used by all health care market participants. It can be realized and used by both standalone devices as well as PC-based instruments. If a direct communication in accordance with this description is not technically feasible (e.g. older standalone devices with vendorspecific interface), a suitable GDT driver program should be provided by the device manufacturer. The new version is expected to develop into a voluntary standard for manufacturers of medical information systems and manufacturers of medical technology devices. A certificate will be held by the QMS. (The interface description is adopted by the Zentralinstitut (Central Institute) as an adjunct to the BDT record type description.) The objective of a further development of this interface description is the realization of a plug & play capability for the connection of medical devices to medical information systems. Thereby, the quality of the connection is improved and installation time is reduced. 1.2 Definition of terms The following important terms are used in the interface description: GDT Device data volume (Geräte-Daten-Träger), (Interface name inspired by BDT, LDT, ADT, KVDT, …). GERÄT (DEVICE) Medical technology device (or corresponding driver program), standaloneunit or PC-based measuring device. PVS Medical office administrative system ((Arzt-)PraxenVerwaltungsSystem). KOMPONENTE (COMPONENT) Every participant of the data exchange, PVS (administrative system) or device (Gerät). SERVER COMPONENT which waits for external requests and commands to be processed. (Annotation: The server in a PC network responds only to requests from the workstations). CLIENT COMPONENT, which sends requests and commands. The terms CLIENT / SERVER are used here only to describe the transmitter and receiver behavior, and are therefore independent of PVS and DEVICE. At the time of installation it has to be determined which of the installed components works as SERVER or CLIENT to avoid conflicts. Because the real goal of a device connection is the communication of study data, a PVS should be able to work at least as SERVER (processing examination data) and a DEVICE should be able to work at least as CLIENT (sending examination data) (see 1.4). GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 7 von 57 Date: 10/01/2013 1.3 Communication Basically, data communication is possible via three different mechanisms: • File-interface The communication between DEVICE and PVS takes place via files which are created in specified directories (see below). • Serial interface A connected DEVICE (or driver program) communicates with the PVS via serial interface. • Program-program interface DEVICE and PVS support program - program interfaces (like Clipboard, DDE, OLE, UNIXPipes). This version of the interface description is limited to the first two mechanisms: File interface and Serial interface. An extension to program-program interfaces is planned. Since all messages are transmitted in the form of GDT sets, the used data format is independent of the used communication channel. 1.4 Labeling of the interface properties 1.4.1 General remarks To clearly determine the technical description of the interface capability of different COMPONENTS, a specific labeling is used which is defined differently for PVS and DEVICE. To find out whether or not a specific PVS can communicate with a DEVICE it is only necessary to check the interface labels. A communication is possible, if at least one way of communication (serial or file related) and at least one SERVER-/CLIENT specification match. The technical documentation of a GDT enabled DEVICE or PVS therefore has to contain a corresponding specification about the nature of the realized interface. 1.4.2 Minimum requirement for PVS and DEVICE The PVS should be able to work as a SERVER at least, that is being reply to record type 6300 with record type 6301 and being able to process record types 6310. The DEVICE should work as a CLIENT at least, that is being able to send record types 6310 1.4.3 Labeling for PVS GDT-<xx>-<nn> <xx> <nn> Example: =S Serial data transmission according to GDT is supported =D Data transmission via files according to GDT is supported = SD Both methods are supported = 10 PVS can work as a SERVER = 01 PVS can work as a CLIENT = 11 PVS can work as a SERVER or a CLIENT GDT-S-10 / PVS can only work as a serial SERVER, GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 8 von 57 Date: 10/01/2013 GDT-D-11 1.4.4 Labeling for DEVICE GDT-<xx>-<nn> <xx> <nn> Example: 1.4.5 can work via file as SERVER and CLIENT =S Serial data transmission according to GDT is supported =D Data transmission via files according to GDT is supported = SD Both methods are supported = 01 DEVICE can work as a SERVER = 10 DEVICE can work as a CLIENT = 11 DEVICE can work as a SERVER or a CLIENT GDT-D-10 can work via file as SERVER and CLIENT Examples for possible combinations PVS / DEVICE Here are examples of COMPONENTS which can communicate with each other: PVS DEVICE GDT-S-11 GDT-SD-01 GDT-D-10 GDT-D-11 GDT-SD-01 GDT-S-01 Here are examples of COMPONENTS which cannot communicate with each other: PVS DEVICE GDT-S-11 GDT-D-11 GDT-SD-10 GDT-S-01 2 Interface description 2.1 Identification of the components (GDT-ID) The GDT-ID is used to uniquely identify the components involved in the communication and is set during installation. The ID consists of a total of 8 random characters which are allocated manufacturer and devicespecifically. Since the entire message assignment is based on this ID, it is essential to ensure a unique allocation; especially for DEVICES which exist multiple times in a room (like ECG recorders of the same manufacturer). 2.2 Character set The allowed character set within the GDT frame is the IMB-8-Bit character set (code page 437) with ≥ 20 hex characters (32 dec.). Furthermore, additional character sets can be supported. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 9 von 57 Date: 10/01/2013 2.3 Communication via file 2.3.1 File names The transmission of information takes place via (text) files whose file name is to be clearly defined during installation. The structure of the file name is defined in the following way: <token of receiver>< token of sender>.<incrementing number> (e.g.: PVS2GER.005) or < token of receiver>< token of sender>.GDT (e.g.: PVS2GER.GDT) or < token of receiver>< token of sender>_<incrementing number>.GDT (e.g.: PVS2GER_4711.GDT) The file name is composed of a maximum of 4 characters as a token for the receiver and a maximum of 4 characters as a token for the sender of the file (see above). The file name extension (Extension) is a 3-digit incrementing number that is sequentially assigned for a specific file name. The file number starts with .001 (guiding zeros) at a continuous extension. This ensures that multiple files (for example multiple files from one DEVICE) can be sent to the PVS. Note: If it is foreseeable that the three digits of the extension are not sufficient for the consecutive numbering, the extension can also be inserted into the file, as long as the receiver can process file names of this sort(e.g.: PVS2GER_4711.GDT). Some operating systems have restrictions regarding the extension of the file name. If certain systems can only configure one specific file name, the extension “GDT” should be provided for it (e.g.: PVS1EKG1.GDT). The used file type (fixed or incrementing) is to be defined for every DEVICE at the time of installation. The files are produced by the respective sender, whereas the extension is incremented accordingly. If a file with the extension ‘.GDT’ is still present (receiver has not yet read the file) it must not be overwritten from the sender (otherwise there will be a loss of data). The processing of the data by the receiver has to happen sorted by date/time (FIFO). After the files have been read, the receiver has to delete the files. To avoid problems in communication, the sender should write the communication file without a pause. If an interruption is necessary, a new file with incremented number has to be generated. If the communication file contains an attachment, the attachment should be initially generated with a temporary file name (e.g.: file name without extension). Only after the writing process is finished, the attachment has to be renamed to the name configured for the receiver. This secures that the communication file is only processed after the whole content has been written down. It is possible that several consecutive sentences exist in a file. It is also possible that multiple record types of different patients are used in one file. 2.3.2 Directory The hard drive and directory in which the communication files are stored have to be determined at the time of installation and have to be specified in the DEVICE-/PVS configuration. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 10 von 57 Date: 10/01/2013 2.4 Communication via serial interface 2.4.1 Hardware The communication happens via three-wire serial cable (RxD, TxD, GND) as minimum requirement, without a hardware-handshake. Optionally, further interface-signals can be supported (RTS, CTS, DTR, etc.). Interface parameter (Minimum requirement) Baud rate = 2400 Baud (optionally others) Date bits = 8 Parity = none Start bits = 1 Stop bits = 1 Connection cable (Minimum requirement) (Pin Assignment for 25-pin plugs / in brackets for 9-pin plugs) a) TxD Pin 2 (3) ─────── (2) Pin 3 RxD (Receive Data) b) RxD Pin 3 (2) ─────── (3) Pin 2 TxD (Transmit Data) c) GND Pin 7 (5) ─────── (5) Pin 7 GND (Signal Ground) d) RTS Pin 4 (7) ─┐ ┌─ (7) Pin 4 RTS (Request To Send) e) CTS Pin 5 (8) ─┘ └─ (8) Pin 5 CTS (Clear To Send) f) Pin 20 (4) ─┐ ┌─ (4) Pin 20 DTR (Data Terminal Ready) g) DSR Pin 6 (6) ─┤ ├─ (6) Pin 6 DSR (Data Set Ready) h) DCD Pin 8 (1) ─┘ └─ (1) Pin 8 DCD (Data Volume Detect) DTR For a simple connection only lines a) + b) + c) are necessary. To use a software protocol, lines d) + e) on both sides of the lines and lines f) + g) + h) have to be overridden. The maximal cable length is dependent of the Baud rate that shall be used. Important: The mapped description is the crossed version of a) + b)! A “1:1” variant is possible, however, depending on the type of the device. In this case Pin 2 of the first device is connected to Pin 2 of the second device. The same happens then for Pin 3 (although this does not happen very often). Please contact the respective producer of the device to clarify the correct polarity. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 11 von 57 Date: 10/01/2013 2.4.2 Procedure of communication The defined set and field identifiers are used as data fields. All data fields are transmitted in a fixed block format (see Annex A). Since a personal software handshake is defined within the protocol, the use of an external handshake software (XONXOFF) is not necessary. To maintain compatibility, the set and line lengths of the transmitted files are always calculated with CR / LF (as defined in the GDT). Rather than sending those two characters, a field separator (1Ch) is sent since CR is defined as the separator for a serial transmission (see examples in Annex A). 2.5 Examples to the procedure The examples are based on the following office-compilation with the listed components. The medical office works with PVS “PRAX_PVS” (GDT-SD-11) and has three connected devices: (1) A phoropter (GDT-S-10) which is connected via serial line and which can only send examination data to the PVS by the push of a button (not using master data management), (PVS is the SERVER / DEVICE is the CLIENT). (2) A PC-based ECG recorder (GDT-D-01) which has its own master data management and which is opened from the file card (PVS is the CLIENT / DEVICE is the SERVER). The corresponding PC program to start the ECG is located at C:\REST: ECG and is called ECG.BAT. (3) A pulmonary function setup (GDT-D-10) with incorporated master data management which is operated from the device and communicates with the PVS (PVS is the SERVER / DEVICE is the CLIENT). The spirometry program is called D: \ LUFU SPIRO.exe. 1. Communication between PVS and phoropter (no possibility for master data management PVS = SERVER DEVICE = CLIENT Metering at the phoropter is performed The push of a button on the DEVICE sends the test results as record type 6310 via serial line PVS receives data and associates it with the current patient GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 12 von 57 Date: 10/01/2013 2. Communication between PVS and ECG recorder PVS = CLIENT DEVICE = SERVER Patient for the next examination is chosen in the PVS PVS writes file F: \ GDT \ EKG1PVS1.001 with record type 6302 to request a new examination (resting ECG: 8402 = EKG01) Switchover to device software by opening the program via the ECG.BAT in the directory C:\REST.ECG DEVICE reads/processes and deletes the file F:\GDT\EKG1PVS1.001 Resting ECG for the (from the DEVICE) transmitted patient is performed DEVICE writes file F: \ GDT \ PVS1EKG1.001 with record type 6310 to communicate the results, exit the program and then switch to PVS PVS reads and deletes file F: \ GDT \ PVS1EKG1.001 PVS assigns data to the current patient 3. Communication between PVS and pulmonary function setup PVS = Server DEVICE = CLIENT Patient for the examination is available in the PVS The push on a button of the the DEVICE requests patient data: DEVICE writes file F:\GDT\PVS_LUFU.001 with record type 6300 to request the current patient data PVS reads/processes and deletes the file F: \ GDT \ PVS_LUFU.001 PVS writes the file F: \ GDT \ LUFU_PVS.001 with record type 6301 to transmit the current master data set DEVICE reads/processes and deletes the file F:\GDT\LUFU_PVS.001 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 13 von 57 Date: 10/01/2013 Spirometry for the (from PVS transmitted) patient is performed DEVICE writes file F:\GDT\PVS_LUFU.002 with record type 6310 to transfer the results Another spirometry for the same patient is performed DEVICE writes the file F:\GDT\PVS_LUFU.003 with record type 6310 to transfer the results PVS reads/processes and deletes the files F:\GDT\PVS_LUFU.002 and PVS_LUFU.003 PVS allocates the files to the patient GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 14 von 57 Date: 10/01/2013 2.6 Annotated example files 2.6.1 Structure of a GDT line: 0163101Schmidt<CR><LF> Length of line incl. CR LF Field identifier of the line content Content of the resp. data field End of line (CR/ LF) 2.6.2 Example file “Transmission of master data” (Stammdaten übermitteln) (6301) 01380006301↓↵ ; Record type “Transmission of master data” (Stammdaten übermitteln) 01681000000292↓↵ ; Record length 0228200Obj_Kopfdaten↓↵ ; Start identifier object „Obj_Kopfdaten“ (Obj_header_data) 0178315EKG_TYP1↓↵ ; GDT-ID of the receiver (e.g. ECG recorder) 0178316PRAX_PVS↓↵ ; GDT-ID of the sender 014921803.01↓↵ ; Version number GDT 01082015↓↵ ; End of object (Object contains 5 fields) 0208200Obj_Patient↓↵ ; Start identifier object “Obj_Patient” (Obj_patient) 014300002345↓↵ ; Patient number 0193101Doe↓↵ ; Name 0143102John↓↵ ; First name 017310301101945↓↵ ; Date of birth (DOB) 01031101↓↵ ; Gender (1=male) 01082017↓↵ ; End of object (Object contains 7 fields) 0288200Obj_Basisdiagnostik↓↵ ; Start identifier object “Obj_Basisdiagnostik” (Obj_basic_diagnostics) 0153622178.00↓↵ ; Height 0153623079.00↓↵ ; Weight 01082014↓↵ ; End of object (Object contains 4 fields) 011820219↓↵ ; End of record (Record contains 19 fields) ↓↵ = CR / LF Each line has to be closed with CR / LF (0D 0A hex)! GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 15 von 57 Date: 10/01/2013 2.6.3 Example file “Transmission of examination data” (Daten einer Untersuchung übermitteln) (6310) 01380006310↵↓ ; Record type 01681000001073↵↓ ; File length 0228200Obj_Kopfdaten↵↓ ; Start of a new object (Obj_header_data) 0178315PRAX_PVS↵↓ ; GDT-ID of the receiver 0178316LZBD_SYS↵↓ ; GDT-ID of the sender 014921803.01↵↓ ; Version number GDT 01082015↵↓ ; End of object 0208200Obj_Patient↵↓ ; Start of a new object (Obj_patient) 014300002345↵↓ ; Patient number 0193101Doe↵↓ ; Name 0143102John↵↓ ; First name 017310301101945↵↓ ; Date of birth (DOB) 01031101↵↓ ; Gender (1=male) 0082017↵↓ ; End of object 0288200Obj_Basisdiagnostik↵↓ ; Start of new object (Obj_basic_diagnostics) 0153622178.00↵↓ ; Height 0153632079.00↵↓ ; Weight 0148402BDM01↵↓ ; Examination: 24h blood pressure 017620023101998↵↓ ; Date of the examination 0346220Dies∨ist∨ein∨zweizeiliger↵↓ ; Findings 1 line (0346220This st is a two line …) 0416220Befund∨zur∨24h-Blutdruckmessung.↵↓ ; Findings 2 nd line (…0416220finding of a 24h blood pressure reading) 0566227Anmerkungen∨zu∨einer∨Langzeit-Blutdruckmessung.↵↓ ; Commentary (056627Commentary to a permanent blood-pressure reading 0506228Kurzzusammenfassung∨24∨h∨Blutdruckmessung↵↓ ; formatted text of results (Conclusion of the results) 0596228--------------------------------------------------↵↓ GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 16 von 57 Date: 10/01/2013 0596228∨∨∨∨∨∨∨∨∨∨diurnal phase∨∨∨∨∨∨∨nocturnal phase∨∨∨percentage loss ↵↓ 0596228∨∨∨∨∨∨∨∨∨6 AM – 10 PM∨∨∨∨∨10 PM – 6 AM∨∨∨∨∨Day/Night↵↓ 0596228Ps[mmHg]∨∨∨∨∨143∨∨∨∨∨∨∨∨∨∨∨∨∨∨134∨∨∨∨∨∨∨∨∨∨∨∨∨∨-6∨%↵↓ 0596228Pd[mmHg]∨∨∨∨∨∨92∨∨∨∨∨∨∨∨∨∨∨∨∨∨∨92∨∨∨∨∨∨∨∨∨∨∨∨∨∨∨0∨%↵↓ 0596228HF[P/min]∨∨∨∨∨∨71∨∨∨∨∨∨∨∨∨∨∨∨∨∨∨70∨∨∨∨∨∨∨∨∨∨∨∨∨-1∨%↵↓ 0168410SYSMXTG↵↓ ; Test identification (Manufacturer specific) 0298411Systole∨max∨Tagphase↵↓ ; Name of the test (Systole max. diurnal phase) 0128420142↵↓ ; Value 0138421mmHg↵↓ ; Unit 017843223101998↵↓ ; Date of reading 0158439163400↵↓ ; Time of reading 0128462140↵↓ ; Upper limit 0168410SYSMNTG↵↓ ; Next test identification 0298411Systole∨min∨Tagphase↵↓ ; Name of the test (Systole min. diurnal phase) 0128420112↵↓ ; Value 0138421mmHg↵↓ ; Unit 017843224101998↵↓ ; Date of reading 0158439031200↵↓ ; Time of reading 011820129↵↓ ; End of object 011820244↵↓ ∨ ↵↓ = = blank space CR and LF (20 hex) resp. (32 decimal) (0D 0A hex) resp. (13 10 decimal) 3 Code page In the following, the record types 6300, 6301, 6302, 6310 and 6311, which are the ones defined for the connection of medical devices, are described Every record starts with the field “8000” which marks the respective record type. Only the record type 6300 “Request master data” (Stammdaten anfordern) requires the record type 6301 “Transmission of master data” (Stammdaten übermitteln) in response. The other record types (6301, 6302, 6310 and 6311) can be transmitted at any time and do not require a response. Generally, the following directions of communication can be applied: 6300: DEVICE PVS 6301: PVS DEVICE GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 17 von 57 Date: 10/01/2013 6302: PVS DEVICE 6310: DEVICE PVS 6311: PVS DEVICE DEVICE = Medical device PVS = Medical office administrative system ((Arzt-)PraxenVerwaltungsSystem) Please note: • The objects described in the record types are stored in a separate file „GDTObjektkatalog“ (GDT object catalogue). Updates to the objects are performed in this file, but it has no influence on the currently present version of the interface. • Column “Occurrence” The frequency of the field is presented in the column “Occurrence” whereas the specification “n” marks those fields which can occur any number of times. Additionally, a level of hierarchy is allocated to every field in the column “Occurrence” . This means the appearance of this field is connected to the existence of another field, that is exactly the field which the superior level of hierarchy refers to. • In The column “Existence”, M and C stands for ‘must’ or ‘can’ exist. • The following exemplary extract of a record chart shall illustrate the structure of a record according to the specifications in the column “Occurrence” Field identifier Occurrence Label Existence 1 of the field contents must/ca Condition n (M/C) 2 3 4 Annotations … 8401 1 Field 8401 can only occur one time per record n Field 8410 can occur any number of times … 8410 8411 1 Field 8411 can only occur one time per field 8410 n Field 8460 can occur any number of times per 8410. … 8460 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 18 von 57 Date: 10/01/2013 3.1 Definition of record types: Request master data (Stammdaten anfordern) „6300“ SA 6300 Field identifier Änd. Header data Patient Healthinsurance card Occurrence Label Existence 1 of the field contents M/C Condition Record identification Length of record Obj_Kopfdaten (Obj_header_data) Obj_Patient Obj_Versichertenkarte (Obj_health-insurance_card) M C M Record type: Request master data Length of record See Annex D M C See Annex D See Annex D End of record M Contains the number of transmitted fields including FK 8000 and FK 8202 8000 8100 xxxx 1 1 1 xxxx xxxx 1 1 8202 1 2 3 4 Annotations 3.2 Definition of record types: Transmission of master data (Stammdaten übermitteln) „6301“ SA 6301 Field identifier Änd. Header data Patient basic diagn. Healthinsurance card Occurrence Label Existence 1 of the field contents M/C Condition 2 3 4 Annotations 8000 1 Record identification M 8100 xxxx 1 1 C M xxxx xxxx 1 1 M C See Annex D See Annex D xxxx 1 Length of record Obj_Kopfdaten (Obj_header_data) Obj_Patient Obj_Basisdiagnostik (Obj_basic_diagnostics) Obj_Versichertenkarte (Obj_health-insurance_card) Record type: Transmission of master data Length of record See Annex D C See Annex D 8202 1 End of record M Contains the number of transmitted fields including FK 8000 and FK 8202 3.3 Definition of record types: Request new examination (Neue Untersuchung anfordern) „6302“ SA 6302 Field identifier Änd. Occurrence Label Existence 1 of the field contents M/C Condition Record identification Length of record Obj_Kopfdaten (Obj_header_data) Obj_Patient Obj_Anforderung (Obj_request) Obj_Basisdiagnostik (Obj_basic_diagnostics) Obj_Dauermedikament (Obj_permanent_medication) M C M Record type: request new examination Length of record See Annex D M M C See Annex D See Annex D See Annex D C See Annex D Obj_Anforderung (Obj_request) C See Annex D 8000 8100 xxxx 1 1 1 xxxx xxxx xxxx 1 1 1 Permanent medication xxxx 1 Request xxxx 1 Header data Patient Request basic diagn. 2 3 4 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 19 von 57 Annotations Date: 10/01/2013 SA 6302 Field identifier Änd. Occurrence of the field contents M/C Condition Permanent diagnosis xxxx 1 Obj_Dauerdiagnosis (Obj_permanent_diagnosis) C See Annex D Healthinsurance card xxxx 1 Obj_Versichertenkarte (Obj_health-insurance_card) C See Annex D Referral xxxx xxxx xxxx xxxx xxxx 1 1 1 1 1 Obj_Überweisung (Obj_referral) Obj_Diagnosis Obj_Anhang (Obj_Annex) Obj_Empfänger (Obj_receiver) Obj_Arztidentifikation (Obj_physician_identification) C C C C C See Annex D See Annex D See Annex D See Annex D See Annex D 8202 1 End of record M Contains the number of transmitted fields including FK 8000 and FK 8202 Diagnosis Annex Receiver Physician identification 1 2 3 4 Label Existence Annotations 3.4 Definition of record types: Cancel requested examination (Angeforderte Untersuchung stornieren) „6303“ SA 6303 Field identifier Änd. Occurrence Label Existence 1 of the field contents M/C Condition 2 3 4 Annotations 8000 1 Record identification M 8100 xxxx 1 1 C M xxxx xxxx xxxx 1 1 1 M M C See Annex D See Annex D See Annex D xxxx xxxx 1 1 Length of record Obj_Kopfdaten (Obj_header_data) Obj_Patient Obj_Anforderung (Obj_request) Obj_Basisdiagnostik (Obj_basic_diagnostics) Obj_Anforderung (Obj_request) Obj_Dauermedikament (Obj_permanent_medication) Record type: cancel requested examination Length of record See Annex D C C See Annex D See Annex D Permanent diagnosis xxxx 1 Obj_Dauerdiagnosis (Obj_permanent_diagnosis) C See Annex D Healthinsurance card xxxx 1 Obj_Versichertenkarte (Obj_health-insurance_card) C See Annex D Referral xxxx xxxx xxxx xxxx xxxx 1 1 1 1 1 Obj_Überweisung (Obj_referral) Obj_Diagnosis Obj_Anhang (Obj_Annex) Obj_Empfänger (Obj_ receiver) Obj_Arztidentifikation (Obj_physician_identification) C C C C C See Annex D See Annex D See Annex D See Annex D See Annex D 8202 1 End of record M Contains the number of transmitted fields including FK 8000 and FK 8202 Header data Patient Request basic diagn. Request Permanent medication Diagnosis Annex Receiver Physician identification GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 20 von 57 Date: 10/01/2013 3.5 Definition of record types: Transmission of examination data (Daten einer Untersuchung übermitteln) „6310“ SA 6310 Field identifier Änd. Header data Patient Request basic diagn. Request Healthinsurance card Occurrence Label Existence 1 2 of the field contents M/C Condition 8000 1 Record identification M 8100 xxxx 1 1 C M xxxx xxxx xxxx 1 1 1 M M C See Annex D See Annex D See Annex D xxxx xxxx 1 1 Length of record Obj_Kopfdaten (Obj_header_data) Obj_Patient Obj_Anforderung (Obj_request) Obj_Basisdiagnostik (Obj_basic_diagnostics) Obj_Anforderung (Obj_request) Obj_Versichertenkarte (Obj_health-insurance_card) Record type: Transmission of examination data Length of record See Annex D M C See Annex D See Annex D 6200 6205 6206 6210 1 C C C M MMDDYYYY of examination 1 Day of storage for treatment data Current Diagnosis Central pharmaceutical number Medication prescribed 1 Medication without prescription M Number of packages (factor) Information about intake Free of charge Nocturnal BVG Accident Me-too prescription Findings External findings C C C C C C C C C n 1 6211 6214 6218 6406 6407 6408 6409 6431 6220 6221 1 1 1 1 1 1 1 N N 6227 6226 N N 6228 Annex xxxx 6330, 6332, 6334, … 6398 6331, 6333, 6335, … 6399 8405 3 If 6206 exists If 6206 exists 0=no, 1=yes 0= no, 1=yes 0= no, 1=yes 0= no, 1=yes 0= no, 1=yes e.g. findings notice generated by the device Commentary C Number of following lines after the C identifier n 1 n 1 1 4 Annotations Result text, formatted m Obj_Anhang (Obj_Annex) Name of the free category C C Content of the free category M Patient information C GDT- Gerätedatenträger, Version:3.0, Release 1.0 If 6226 exists With this, the GDT length restriction in 6228 transmissions can be bypassed. For example, if the value 2 is assigned here, the following two 6228 lines make an overall row that should be assembled by the receiver. Random result text, formatted by the device See Annex D Even and following odd field identifiers belong together. If previous field identifier “Name of the free category” exists. Seite 21 von 57 Date: 10/01/2013 SA 6310 Field identifier Änd. Occurrence of the field contents M/C Condition Physician identification xxxx 1 Obj_Arztidentifikation (Obj_physician_identification) C See Annex D 8202 1 End of record M Contains the number of transmitted fields including FK 8000 and FK 8202 1 2 3 4 Label Existence Annotations 3.6 Definition of record types: Display data of an examination (Daten einer Untersuchung zeigen) „6311“ SA 6311 Field identifier Änd. Header data Patient Request Physician identification Occurrence Label Existence 1 2 3 4 Annotations of the field contents M/C Condition 8000 1 Record identification M 8100 xxxx 1 1 C M xxxx xxxx 4111 xxxx 1 1 1 1 Length of record Obj_Kopfdaten (Obj_header_data) Obj_Patient Obj_Anforderung (Obj_request) Health insurance number Obj_Arztidentifikation (Obj_physician_identification) M M C C See Annex D See Annex D 8202 1 End of record M Contains the number of transmitted fields including FK 8000 and FK 8202 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 22 von 57 Record type: display data of an examination Length of record See Annex D See Annex D Date: 10/01/2013 4 Field chart A chart of the field identifies that are used in the record types 6300, 6301, 6302, 6310, 6311. * Changes in the field chart are labeled as following at the most left column: *L Change of length *N New field which has been allocated only for the “GDT” version in accordance with the Central Institute *R Rule changes to preceding version Rule number for format and content checks * Nx.x New field from version x.x onwards * Obj Reference to object catalogue. Field identifier is described there Field identifier Label Length Type 0102 Person/company responsible for software var (alphanumeric)lnum e.g. company 0103 Software var alnum Name of the software 0132 Release stage of software var alnum 12.4 0201 (N)BSNR: Establishment number 9 num 947812345 0202 Name of the payer var alnum German Federal Pension Fund 0212 LANR (lifetime physician number) 9 num 123456789 0950 Central pharmaceutical number for permanent medication var alnum 4877800 0957 Administration form for permanent medication var alnum Caplet 3000 Patient number/patient ID var alnum 123456 3100 Name affix of the patient var alnum Von 3101 Name of the patient var alnum Doe 3102 First name of the patient var alnum Jane 3103 DOB of patient (MMDDYYYY) 8 date 3104 Title of the patient var alnum Dr. 3105 Health-insurance number of the patient var alnum 123456M789 3106 Full residence of the patient var alnum 50859 Cologne (Germany) 3107 Home street of the patient var alnum Holzweg 106 3108 Type of insurance, MFR 1 num 116 3 3110 Gender of the patient 1 num 112 1 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 23 von 57 Rule 020/304 Example 04121946 Date: 10/01/2013 Field identifier Label Length Type 3112 Postal code of the patient var alnum 50859 3113 Hometown of the patient var alnum Cologne 3114 Residence country code var alnum GER 3116 Health-insurance area 2 num 17 3119 Health-insurance number (electronic health card in Germany) of the patient 10 alnum A123456780 3618 Cellphone number of the patient var alnum 0049-172 9335 172 3619 Email address of the patient var alnum j.doe@dummy.com 3622 Height of the patient in cm var float 175.50 3623 Weight of the patient in kg var float 90.50 3626 Phone number of the patient var alnum 0049-951 3458 200 3628 Native language of the patient var alnum English 3649 Start of permanent diagnosis 8 date 01012012 3650 Permanent diagnosis var alnum Diabetes mellitus 3651 Start of permanent medication 8 date 12112011 3652 Permanent medicament var alnum Adalat 3654 Risk factor var alnum Smoker 3656 Allergies var alnum Neurodermatitis 3658 Accidents var alnum Motor bike accident 3660 Surgeries var alnum Appendix 3662 Anamnesis var alnum Premature delivery 3664 Number of deliveries var num 2 3666 Number of children var num 3 3668 Number of pregnancies var num 4 3670 Permanent therapy var alnum Patient-controlled Analgesia (PCA) 3672 Follow-up appointment 8 date 01121993 3673 Permanent diagnosis ICD-Code 3,5,6 alnum E10.21 3674 Diagnostic confidence for permanent diagnosis 1 alnum Z 3675 Body side localization for permanent diagnosis 1 alnum R 3676 Diagnosis explanation for permanent diagnosis var alnum ECG definite 3677 Diagnosis derogation for permanent diagnosis var alnum true GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 24 von 57 Rule Example Date: 10/01/2013 Field identifier Label Length Type 3700 Label of the basic-diagnostic category var alnum Cardiovascular family history 3701 Content of the basic-diagnostic category var alnum Yes 4104 No. of contracted health insurance 5 num 27106 4106 Payer billing area 2 num 00 4109 Day of last reading of the healhinsurance card in the quarter 8 date 07082012 4110 Valid-to date 4 num 0913 4111 Health-insurance number 7 num 12568008 4112 Insurance status 4 num 1000 4113 Status addition / DMP-labeling 1 alnum 1 4121 Schedule of fees 1 num 1 4122 Billing area 2 num 00 4200 Desired date (MMDDYYYY) var alnum 05142002 4202 Accident, Consequences of accident 1 num 1 4203 Treatment according to . § 116b SGB V 1 num 4204 Restricted entitlement according to § 18 Abs. 3a SGB V 1 num 4205 Assignment var alnum 4207 (Suspected) Diagnosis var alnum 4208 Findings / Medication var alnum 4209 Assignment/diagnosis/suspicion var alnum X-ray left hand 4217 (N)BSNR: Establishment number of the initiator 9 num 123456700 4218 (N)BSNR Establishment number of the referring person 9 num 234567800 4219 Referral from other physician var alnum General medicine 4220 Referral to var alnum Radiologist 4221 Type of treatment 1 num 1 4229 Exceptional medical indication 5 num 32005 4231 Follow-up exam of a known infection 1 num 4237 Hospital name var alnum XYZ General Hospital 4241 LANR (lifetime physician number) of the initiator 9 num 123456789 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 25 von 57 Rule Example 1 Suspected hepatitis Date: 10/01/2013 Field identifier Label Length Type 4242 LANR (lifetime physician number) of the referring person 9 num 234567890 6001 ICD Code 3,5,6 alnum L50.0 6003 Diagnostic confidence 1 alnum Z 6004 Body side localization 1 alnum R 6006 Diagnosis explanation var alnum clinical 6008 Statement of facts for a diagnosis derogation var alnum Condition after gender reassignment 6200 Day of storage of treatment data (MMDDYYYY) 8 date 6201 Time of treatment data elicitation 6 time 110435 6205 Current diagnosis var alnum Diabetes test 6206 Central pharmaceutical number var alnum 4877800 6210 Medication prescribed var alnum Adalat 6211 Medication without prescription var alnum Sostril 6214 Number of packages (factor) 3 num 008 6218 Information about intake var alnum 1-0-0 6220 Findings var alnum High blood pressure 6221 External findings var alnum Suspicion of obstruction *N2.1 6226 Number of following lines after the identifier 6228 var num 2 *N 6227 Commentary var alnum Belastung abgebrochen *N 6228 Formatted result charts text var alnum See examples in annex 6302 File archiving label var alnum 000001 6303 File format var alnum PDF 6304 Content of file var alnum File analysis 6305 File path var alnum \\FS1\DATA\00712.PDF 6329 Content of the file in BASE64coded attachment var alnum *N2.1 63306398 Name of the free category var alnum PATINFO *N2.1 63316399 Content of the free category var alnum Patient is cheerful 6406 Free of charge 1 num 0=no, 1=yes 6407 Noctu 1 num 0=no, 1=yes 6408 BVG 1 num 0=no, 1=yes 6409 Unfall 1 num 0=no, 1=yes GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 26 von 57 Rule 008 Example 12261993 Date: 10/01/2013 Field identifier Label Length Type 6431 Aut Idem 1 num 0=no, 1=yes 8000 Record identification 4 alnum 6301 8100 Length of record 7 num 0000747 8200 ObjektIdent (object identifier) var alnum e.g.: Obj_Kopfdaten (Obj_header_data) 8201 End of object var num Contains the number of transmitted fields in the object, including 8200 and 8201 8202 End of record var num Contains the number of transmitted fields in the record, including 8000 and 8202 (Example: 7) 8310 Request identifier var alnum 223 8314 Request UID var alnum Secured and unique request ID (UID) *N 8315 GDT-ID of the receiver var alnum ROP200U1 *N 8316 GDT-ID of the sender var alnum PRAX_PVS *L 8402 Device and process specific characteristic map var alnum ECG01, see Annex B 8403 Schedule of fees 1 num 1 8404 Subcategory to field identifier 8402 8405 Information about patient var alnum Additional information: Overweight 8407 Gender 1 num 2 8410 Test identifier var alnum FEV1 8411 Label of test var alnum Obj. refr. cyl. right 8412 Test-OID var alnum 8413 Test/device ID var alnum 8418 Status of the test 1 alnum B 8420 Result value var float -3.70 8421 Unit var alnum Diopter 8425 Budget-free 1 num 1 8428 Sample identifier var alnum SE 8429 Sample index 2 num 01 8430 Sample label var alnum Smear test 8431 Sample specification var alnum Left eye 8432 Date of collection (MMDDYYYY) 8 date GDT- Gerätedatenträger, Version:3.0, Release 1.0 Rule Example Left kidney Seite 27 von 57 008 01311994 Date: 10/01/2013 Field identifier Label Length Type 8433 Time of collection 6 time 091520 *N 8437 Unit(s) for data stream var alnum Min, mmHg, mmHg *N 8438 Data stream var alnum 5,120,80… or (5,120,80),(10,128,92)… can contain float values *N*R 8439 Time of collection 6 time 8460 Normal value text var alnum negative *N 8461 Normal value lower bound var float -15.00 *N 8462 Normal value upper bound var float 12.00 8470 Test-related notes var alnum Frozen serum required 8480 Results text var alnum negative 8501 Urgency 1 num 1 (1=emergency, 2=urgent) 8504 Intake of medication at the time of sample collection var alnum 8510 Pregnancy 1 num 1 (0=nein, 1=ja) 8511 Gestation length (in weeks, days) 3 num 24,2 8512 1st day of cycle (MMDDYYYY) 8 date 09102012 8601 Name of invoice recipient var alnum Doe 8602 Title, Forename of invoice recipient var alnum Dr. Jane 8606 City of residence of the invoice recipient var alnum 50226 Cologne 8607 Street of residence of the invoice recipient var alnum Main Street 1 8608 Commentary/Reference number var alnum 222/234AH 8609 Type of billing 1 alnum P 8610 Private charges 1 num 2 8615 Principal var alnum 123456600 8990 Signature (sign of initials) var alnum Dr. Huber 9103 Date of creation (MMDDYYYY) 8 date 10202012 *N2.1 9152 Counter URL 4 num 1 *N2.1 9153 Description URL var alnum Data scale of Pat. 00712 *N2.1 9154 URL var alnum \\FSI\DATA\00712.PDF *N2.1 9206 Used character set 1 num 2 *N 9218 Version GDT 5 alnum 03.00 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 28 von 57 Rule 090 Example 125600 Date: 10/01/2013 date = Date in the format MMDDYYYY time = Time in the format HHMMSS num = numerical, fields with fixed lengths have to be filled with leading zeros alnum = alphanumerical float = Floating-point number with a dot as decimal mark. 5 Chart of rules The rules are divided into number ranges according to their nature: 000 – 099 Format check 100 – 199 Content check 200 – 299 Existence check 300 – 399 Context check No. of rule. Category Check Description 008 Format MMDDYYYY MM=Month, DD=Day, YYYY=Year 020 Format MMDDYYYY Range of value: MM=00-12, DD=00-31; JJJJ=0000-9999 090 Format HHMMSS HH=Hours; MM=Minutes; SS=Seconds Range of value: HH=00-24; MM=00-59; SS=00-59 (possibly missing seconds have to be inserted with 00) 112 Allowed content 1, 2 116 Allowed content 1, 2, 5 Type of insurance MFR 304 Context Datum kleiner oder gleich Maschinendatum Avoid key errors 6 Annex 6.1 Annex A: Block format for serial data transmission, including examples 6.1.1 Transmission protocol The file is transferred in blocks. The reception of a transmission block has to be confirmed within 10 seconds by sending an ACK (06h), followed by a 1 (31h) for a complete and correct transmission or a 0 (30h) for an incomplete transmission. 6.1.2 Transmission block A transmission block is constructed as follows: <Send sequence number><Label>[<data field>]<CRC-16><CR> GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 29 von 57 Date: 10/01/2013 6.1.3 Meaning of the respective fields Send sequence number Length: 1 Byte The send sequence number is incremented cyclically from 1 (31h) to 9 (30h). If the same transmission block has to be resent because of a faulty transmission, the send sequence number remains the same. The value 0 (30h) is used for synchronization. It is used for the first transmission after switching on the device and after the occurrence of transmission errors. Label Length: 3 Bytes The following labels are defined: B00 Start of transmission / first data block B01 Data block B02 End of transmission / last data block Data field Length: max. 128 Bytes The data field contains the actual data. Multiple lines can be combined into a data field. A line can also be distributed across several data fields. The character 1 Ch (field separator FS) is used for the separation of two lines. The record length and length of lines are calculated including CR /LF. With the exception of the field separator, no ASCII-characters smaller than 20h may be used within the data field. CRC-16 Length: 4 Bytes 16 Bit CRC within send sequence number, label and data field. The value is sent as ASCII-Hex. Example: 2A9Eh is sent as 32h 41h 39h 45h. (To generate the checksum according to CRC-16, please refer to the source code examples of older GDT record descriptions or to sources from the internet, such as “WIKIPEDIA”.) CR Length: 1 Byte Carriage return (0Dh) completes the data block. 6.1.4 Examples Please note: The character ‚|‘ signifies the field separator (1Ch). For illustrational purposes the data field length has been limited to 32 characters. 6.1.4.1 Request of master data (see definition charts on p. 19ff. for translation of the object names) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 30 von 57 Date: 10/01/2013 Client sends: C: 1B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 1 Server responds: S: 7B00 01380006301|01681000000217|0228200Obj_Kopfdaten|0178315ROP<CRC> <CR> C: <ACK> 1 S: 8B01 200U1|0178316QMS-GDT1|014921803.00|01082015|0208200Obj_Pat<CRC> <CR> C: <ACK> 1 S: 9B01 ient|014300010027|0123101Axt|0143102Berta|017310301041965<CRC> <CR> C: <ACK> 1 S: 1B02 |01031102|01082017|011820215<CRC> <CR> C: <ACK> 1 6.1.4.2 Procedure when transmission errors occur Upon receipt of <ACK> 0 or after the occurrence of a timeout, the last transmission block is sent again. If an error occurs two times in a row, the send sequence number is set back to 0 and the transmission is repeated from the first data block. After the second unsuccessful attempt to transfer the file, the transmission is aborted. The error handling takes place on a higher level. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 31 von 57 Date: 10/01/2013 6.1.4.3 Examples for transmissions including errors Repetition of a transmission block C: 1B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 Error occured Resend data block with the same send sequence number (in this example, number 2) C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 1 correctly this time the data block is received Synchronization after transmission errors C: 1B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 Error occured Resend data block with the same send sequence number (in this example, number 2) C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 Error occurred a second time C: 0B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> New synchronization with send sequence number 0 S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 1 Abortion of a transmission after transmission errors C: 1B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 Error occured Resend data block with the same send sequence number (in this example, number 2) C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Error occured Seite 32 von 57 Date: 10/01/2013 C: 0B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> New synchronization with send sequence number 0 S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 Error occured C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: <ACK> 0 Error occured Sender stops the transmission. Receiver remains in standby mode. Transmission error at request of master data The problem that both client and server try to send a file can occur in the following situation: C: 1B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> S: <ACK> 1 C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> S: [<ACK> 1] Confirmation of receipt sent by server but the client does not receive it C: 2B02 GDT1|0178316ROP200U1|014921803.00|01082015|01082028<CRC> <CR> Repeated transmission of the same block S: 7B00 01380006301|01681000000217|<CRC> <CR> Server already sends the 1st block of the requested master data C: 0B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> Repeated transmission by the client with a new synchronization S: 7B00 01380006301|0158100000217|<CRC> <CR> Server repeats transmission of the 1st block of the master data (ACK 1 of the client is missing) C: 0B00 01380006300|01681000000119|0228200Obj_Kopfdaten|0178315QMS-<CRC> <CR> Client repeats attempt of synchronization GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 33 von 57 Date: 10/01/2013 S: 0B00 01380006301|0158100000217|<CRC> <CR> Repeated transmission by the server with new synchronization S: 0B00 01380006301|01681000000217|<CRC> <CR> Server repeats attempt of synchronization The transmission is aborted by server and client after the timeout (“wait for ACK”) (see 6.1.4.2). GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 34 von 57 Date: 10/01/2013 6.2 Annex B: Device and process specific characteristic map „8402“ Field 8402 was defined as follows in the revision of the GDT: Field identifier: 8402 Label: Device and process specific characteristic map Function: The field is used to group the transmission data. Typ: The previous type of 2 (alnum) was extended to 1-6 (alnum). Regel: The content of the field consist of one text part with a maximum of 4 characters for the group identifier plus a following 2-digit number ranging from 00-99 (e.g. LUFU09). The number 00 is thereby generally reserved as field identifier for non-specified examinations. The group identifier ALLG (generally ALLG00) is appointed for non-classified examinations. The list of field contents is dynamic and is centrally administered by the ZI (CI). The subsequently listed groups and field identifiers are therefore only a first draft which is optionally extendable. Contrary to the field identifier 8402, the respective Testidents (test identifiers) can be assigned manufacturer-specifically. ALLE__ Allergology ALLE01 Allergological anamnesis ALLE02 Allergological findings ALLE03 Allergological diagnosis ALLE04 Prick test ALLE05 Intradermal test ALLE06 Challenge test (e.g. histamine challenge test) ALLE07 In vitro test ALLE08 Insect poison ALLE09 Patch test ALLE10 Daily desensitization ALLG__ ALLG00 Examinations, general Non-classified examinations APNO__ Sleep apnea examinations APNO00 Apnea, general APNO01 Long-term sleep apnea screening APNO02 Polysomnography AUDI__ GDT- Gerätedatenträger, Version:3.0, Release 1.0 Audiometric examinations Seite 35 von 57 Date: 10/01/2013 AUDI00 Audiometry, general AUDI01 Pure-tone audiogram AUDI02 EEG-Audiometry BDM__ Measurement of blood pressure BDM00 Measurement of blood pressure, general BDM01 Long-term measurement of blood pressure Cardiotocography CTG__ CTG01 Cardiotocography DERM__ DERM01 Dermatology Dermal camera (serial) DICO__ DICOM DICO01 CT DICO02 MRT EKG__ Electrocardiography EKG00 ECG, general EKG01 Resting-ECG EKG02 Arrhythmia-ECG EKG03 Late potentials ECG EKG04 Long-term ECG ERGO__ Stress examinations ERGO00 Stress-examinations, general ERGO01 Stress-ECG ERGO02 Stress flow-volume ERGO03 Blood gases ERGO04 Stress blood gases ERGO05 Spiroergometry ERGO06 Breath gas analysis ERGO07 Pulse oximetry ERGO08 Indirect Calorimetry ERGO09 Indirect Calorimetry with canopy cover ERGO10 Cardiac output determination via CO2 feedback ERGO11 Respiratory drive measurements via CO2 feedback GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 36 von 57 Date: 10/01/2013 FILE__ FILE01 File transfer Camera (Video/Digital), general via interface HÄMA__ Blood count HÄMA01 Smaller blood count HÄMA02 Major blood count HÄMA03 Manual differential leukocyte count HÄMA04 Reticulocytes HÄMA05 CD4/CD8 LUFU__ Pulmonary function test LUFU00 Pulmonary function, general LUFU01 Slow spirometry LUFU02 Forced spirometry (flow volume) LUFU03 MVV (Maximal Voluntary Ventilation) LUFU04 Body plethysmography LUFU05 FRC pl (lung volume – Body plethysmography) LUFU06 FRC He (lung volume – Helium feedback) LUFU07 Resistance after wedge pressure method LUFU08 Resistance after impulse oscillation method LUFU09 Resistance after oscilloresistometry method LUFU10 Compliance LUFU11 Measurement of respiratory muscles LUFU12 Measurement of respiratory drive LUFU13 Diffusion Single-Breath LUFU14 Diffusion Steady-State LUFU15 Diffusion Rebreathing LUFU16 Diffusion membrane factor LUFU17 Capnography LUFU18 Rhinomanometry LUFU19 Calm breath analysis NEUR__ Neurological measurement NEUR00 Neurology, general NEUR01 Long-term EEG NEUR02 EEG with simultaneous ECG recording NEUR03 Motoric NLG GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 37 von 57 Date: 10/01/2013 NEUR04 Sensorial NLG NEUR05 Evoked potential responses NEUR06 Rotational testing NEUR07 Nystagmus analysis NEUR08 Saccades test NEUR09 Posture NEUR10 Biofeedback NEUR11 ERG/EOG NEUR12 EMG of the eye muscles NULL__ NULL01 Empty Device Empty Device, only for sending patient master data to the database OPTO__ Ophthalmology OPTO00 Ophthalmology, general OPTO01 Monocular testing, objective OPTO02 Monocular testing, subjective OPTO03 Monocular testing glasses/contact lense OPTO04 Aperture sensitivity measurement (visual acuity) OPTO05 Perimetry measurement OPTO06 Intraocular pressure measurement OPTO07 Cornea measurement (curvature/axial position) OPTO08 Cornea measurement (3D geometry data) OPTO09 Fundus images OPTO10 Angiography images OPTO11 Slit lamp images OPTO12 Topography images OPTO13 Layer images OPTO14 Generic image data PROV__ Provocation Test PROV00 Provocation, general PROV01 Specific Aerosol provocation PROV02 Unspecific Aerosol provocation PROV03 Cold air provocation PROV04 Bronchodilatation GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 38 von 57 Date: 10/01/2013 SCAN__ SCAN01 Scanner Scanner, general with TWAIN standard SONO__ Sonography measurements SONO00 Sonography, general SONO01 Ultrasound doppler URO__ Urology URO00 Urology, general URO01 Uroflowmetry VDDS__ VDDS01 VDDS dental interface Dental x-ray system with VDDS interface VIDE__ Video coverage VIDE01 Sonography VIDE02 Angiography VIDE03 Endoscopy VIDE04 Laparascopy VIDE05 Arthroscopy VIDE06 Microscopy VIDE20 C-arm XRAY__ XRAY01 X-ray image X-ray image GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 39 von 57 Date: 10/01/2013 6.3 Annex C: Transmission of measurement data Measurement data can have various dimensions. In the easiest case, there is only one single result value, a one-dimensional number which is important in itself. 0 reading point This case of one or more one-dimensional numbers is represented in the GDT with the following sequence 8410 Test-Ident … 8420 Result value Example (Body height at a certain time): 8410 Height … 8420 184 Often, however, the development of measuring data compared to equidistant time frames. Height [cm] Time [months] This case can easily and effectively be displayed with the sequence 8410 Test-Ident … 8417 Bitstream (as single value) Example (Body height over a specific period): 8410 Height … 8417 184,185,187,190,190 If the measuring data is not equidistant, the second dimension has to be directly indicated: 8410 Test-Ident … 8417 Bitstream (as a couple) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 40 von 57 Date: 10/01/2013 Again the same example (Body height and months since start of measurement): 8410 Height … 8417 (184,0),(186,2),(188,7),(190,20) The illustration of several measurement parameters is possible since the sequence 8410 … 8417 can occur n-times. Again the same example (but with the additional evolution of weight next to height): a) At equidistant measurement values (Height and weight were measured in the same time frames): 8410 Height … 8417 (184,65),(186,65),(188,69),(190,72) b) If, however, the measurement values were measured at different times, which means that for every value an additional time reference is given, the following sequence occurs: 8410 Height … 8417 (184,0),(186,2),(188,7),(190,20) … 8410 Weight … 8417 (65,0),(66,4),(69,7),(72,20) Extension of the GDT compared to Version 1.0 But what happens, if the measurement values of several samples (or samples taken at different times) shall be transmitted at the same time, to be displayed comparatively by an analysis program? Until now, the GDT did not offer a direct possibility for such a scenario. Sample 1 Measurement values Sample 2 Time GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 41 von 57 Date: 10/01/2013 Therefore, sample and time of the measurement are defined as a new level of hierarchy: 3000 Patient data … 8402 Measuring device … 8405 Sample … 8406 Date 8407 Time … 8410 Test-Ident … 8420 Measurement values … or 8417 multiple measurement values With the additional introduction of time as a hierarchy level, time series can be transmitted more easily and clearly (compared to the use of multidimensional tuples in field 8417). The possibility of transferring time as an autonomous dimension in the field 8417 continues to exist, however. This gives the following set of data representation: 6310 record Existence 1 3000 Patient data 1 Device 1 Description 1 2 3 4 … 8402 … 6205-6228 … 8405 Sample n … 8406 Date 1 8407 Time 1 8410 Test-Ident n Bitstream n … 8417 GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 42 von 57 Date: 10/01/2013 … 8420 Messwert (alternativ) 1 This kind of display allows the directional representation of all necessary measurement data. It is downward compatible to the GDT Version 1.0! If the fields 8405 (Sample) and 8406 (Date) exist only once or not at all, the structure of the record set is the same (as far as the illustration of data is concerned) as in the GDT Version 1.0. 6.4 Annex D: Building Blocks / Objects Here you find the list of objects that are used in the record description. You can find a detailed description of these objects (composition of the field labels, rules for their existence, descriptions, etc.) in the document “Object catalogue as extension to the xDT data record description” (‘Objektkatalog als Ergänzung zu den xDT-Datensatzbeschreibungen’ in German). Obj_Anforderung (Obj_request) Obj_Diagnosis Obj_Schein (Obj_certificate) Obj_Anhang (Obj_annex) Obj_Einweisung (Obj_admission) Obj_Terminanfrage (Obj_appointment_request) Obj_Arztidentifikation (Obj_physician_identification) Obj_Kopfdaten (Obj_header_data) Obj_Ueberweisung (Obj_referral) Obj_Basisdiagnostikdia (Obj_basic_diagnostics Obj_Patient Obj_Versichertenkarte (Obj_health-insurance_card) Obj_Dauerdiagnosis (Obj_permanent_diagnosis) Obj_RgEmpfänger (Obj_invoice_recipient) Obj_Dauermedikament (Obj_permanent_medication) Obj_Satzende (Obj_end_of_record) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 43 von 57 Date: 10/01/2013 6.5 Example files “Best Practice“ The following example files show common practical processes with their required field labels and record types: Key notes: DEVICE = Medical device, PVS = (Arzt-)PraxenVerwaltungsSystem (medical office administrative system) 6.5.1 Request master data “6300” (DEVICE to PVS) Construction of record type 6300 Commentary Request master data (6300) is a process from the medical device (DEVICE) to the PVS. In the object Obj_Patient, an identification can occur via 3119 as an alternative to the patient number. Otherwise, the data of the current patient is requested. 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Satzende (Obj_end_of_record) Process: DEVICE to PVS. Example as before 6.5.2 Transmission of master data “6301” (PVS to DEVICE) Construction of record type 6301 Commentary 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_ArztIdent (Obj_physician_identification) Example of a minimal master data transmission; generally the object Obj_ArztIdent (Obj_physician_identification) should be transferred in every process where the PVS sends data to the DEVICE. 4. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE. Example with physician identification 6.5.3 Request new examination “6302” (PVS to DEVICE) Example 1: Construction of record type 6302 Commentary Minimal version. The request of an examination, including the physician identification and the request identification. 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) 4. Obj_ArztIdent (Obj_physician_identification) 5. Obj_Satzende (Obj_end_of_record) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 44 von 57 Date: 10/01/2013 Process: PVS to DEVICE. In this case with physician identification Example 2: Construction of record type 6302 Commentary Request of an examination including data of the health insurance card as well as detailed permanent medical information and the basic diagnosis. 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) 4. Obj_Versichertenkarte (Obj_healthinsurance_card) 5. Obj_Basisdiagnostik (Obj_basic_diagnostics) 6. Obj_DauerDiag (Obj_permanent diagnostics) 7. Obj_DauerMed (Obj_permanent_medication) 8. Obj_ArztIdent (Obj_physician_identification) 9. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE. In addition to the musthave objects Obj_Kopfdaten (Obj_header_data) and Obj_Patient, the objects Obj_Versichertenkarte (Obj_health-insurance card), Obj_Basisdiagnostik (Obj_basic diagnostics), Obj_DauerMed (Obj_permanent_medication), and Obj_DauerDiag (Obj_permanent_diagnosis) are transmitted. The medical device is initialized with the permanent medical data, the basic diagnosis and the insurance data. 6.5.4 Transmission of examination data “6310” (DEVICE to PVS) Construction of record type 6310 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Untersuchung (Obj_exam) 4. Obj_Anhang (Obj_annex) 5. Obj_Satzende (Obj_end_of_record) Process: DEVICE to PVS GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 45 von 57 Date: 10/01/2013 6.5.5 Display data of an examination “6311” (PVS to DEVICE) Construction of record type 6311 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) 4. Obj_ArztIdent (Obj_physician_identification) 5. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE; The specification says 4111, but this is not listed in the example. 6.5.6 Appointment request “6302” (PVS to DEVICE) Construction of record type 6302 Commentary 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) 4. Obj_Terminanfrage (Obj_appointment_request) 5. Obj_ArztIdent (Obj_physician_identification) For an appointment request, the fields SMS text message and email address have to be filled out in the object Obj_Patient, to guarantee confirmation of the appointment. In the object Obj_Terminanfrage, the listing of the suspected diagnosis as well as the request of referral to a specialist, are especially important for the ongoing workflow. 6. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE; Phone number for text message or email address have to be assigned to the object Obj_Patient 6.5.7 Referral to specialist “6302” (PVS to DEVICE) Construction of record type 6302 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Kommentar With the process referral to specialist, an appointment request is initiated, which includes detailed permanent medical data and the basic diagnosis. The object Obj_Untersuchung (Obj_exam) can be used to provide previous find- Seite 46 von 57 Date: 10/01/2013 4. Obj_Terminanfrage (Obj_appointment_request) 5. Obj_Basisdiagnostik (Obj_basic_diagnostics) ings. The object Obj_Anhang (Obj_annex) can be used to display the declaration of content or previous findings of other physicians. 6. Obj_Versichertenkarte (Obj_healthinsurance_card) 7. Obj_Einweisung (Obj_admission) 8. Obj_DauerMed (Obj_permanent_medication) 9. Obj_DauerDiag (Obj_permanent diagnostics) 10. Obj_Anhang (Obj_annex) 11. Obj_Untersuchung (Obj_exam) 12. Obj_ArztIdent (Obj_physician_identification) 13. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE; Phone number for text message or email address have to be assigned to the object Obj_Patient 6.5.8 Hospitalization “6302” (PVS to DEVICE) Construction of record type 6302 Commentary 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) 4. Obj_Terminanfrage (Obj_appointment_request) 5. Obj_Basisdiagnostik (Obj_basic_diagnostics) With the process hospitalization, an appointment request is initiated, which includes detailed permanent medical data and the basic diagnosis. The object Obj_Untersuchung (Obj_exam) can be used to provide previous findings. The object Obj_Anhang (Obj_annex) can be used to display the declaration of content or previous findings of other physicians. 6. Obj_Versichertenkarte (Obj_healthinsurance_card) 7. Obj_Einweisung (Obj_admission) 8. Obj_DauerMed (Obj_permanent_medication) 9. Obj_DauerDiag (Obj_permanent diagnostics) 10. Obj_Anhang (Obj_annex) 11. Obj_Untersuchung (Obj_exam) 12. Obj_ArztIdent (Obj_physician_identification) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 47 von 57 Date: 10/01/2013 13. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE; Phone number for text message or email address have to be assigned to the object Obj_Patient 6.5.9 Transmission of emergency data “6302” (PVS to DEVICE) Construction of record type 6302 Commentary In the area of emergency cases, the provision of permanent medical information and basic diagnostics is crucial. Additionally, the required emergency data set can be initialized with this record type. 1. Obj_Kopfdaten (Obj_header_data) 2. Obj_Patient 3. Obj_Anforderung (Obj_request) 4. Obj_Basisdiagnostik (Obj_basic_diagnostics) 5. Obj_DauerMed (Obj_permanent_medication) 6. Obj_DauerDiag (Obj_permanent diagnostics) 7. ArztIdent (Obj_physician_identification) 8. Obj_Satzende (Obj_end_of_record) Process: PVS to DEVICE GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 48 von 57 Date: 10/01/2013 7 Illustration of the workflows The GDT interface was created for the communication of the PVS with all kinds of medical devices (DEVICE). The PVS thereby transmits chosen master data and, if applicable, medical data of a patient to the medical device. The concept of the GDT interface is based on one basic workflow. In reality, however, further workflows exist which shall be displayed in the following section. 7.1 Basic-Workflow 7.1.1 • • Requirements PVS o Selection of patient o (optional) choosing patient o (optional) choosing procedure o (optional) additional text o Creation of a request according to record type 6302 Save as file Sending via V.24 / RS232 interface or Writing in a file according to naming convention of the GDT Waiting for results DEVICE o Waiting for request from PVS o Evaluates the requirement data and starts the requested procedure o Process and evaluation time of the DEVICE GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 49 von 57 Date: 10/01/2013 o • 7.1.2 • Sending via V.24 / RS232 interface or Writing in a file according to naming convention of the GDT Terminating the operation PVS o • Creation of a result and/or end signal with record type 6310 Reception and storage of results data Illustration of results data PVS o Selection of patient o Creation of a request according to record type 6311 Save as file Sending via V.24 / RS232 interface or Writing in a file according to naming convention of the GDT (optional) Waiting for termination of the operation on this DEVICE DEVICE o Selection of the patient’s examination and/or treatment data o Consideration of the results and/or further interactive work with the existing data o Finishing the evaluation 7.2 Storage of patient master data Record type 6301 has been defined to allow the synchronization of databases. The aim is that all master data of the PVS (both new and changed data) can be transmitted to the DEVICE. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 50 von 57 Date: 10/01/2013 7.2.1 Single or direct transmission of data The DEVICE must be able and in the condition to directly receive and process master data. • • PVS o Selection of the patient o Creation of a request according to record type 6301 Save as file Sending via V.24 / RS232 interface or Writing in a file according to naming convention of the GDT NO waiting on the DEVICE DEVICE o 7.2.2 Takeover of the master data into the own database Batch transmission of master data In this mode, the transmission via serial interface is not possible. However, the DEVICE does not have to able to receive master data permanently, but can do this periodically. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 51 von 57 Date: 10/01/2013 • • PVS o Selection of the patient o Creation of a request according to record type 6301 Save as file Writing in a file according to naming convention of the GDT NO waiting on the DEVICE DEVICE o Takeover of the master data into the own database 7.3 Simple form of a GDT request In reality, it has turned out that for many executions only a simple data transmission has been realized. This simple form was mostly the result of the necessity to actively control the DEVICE with the PVS. The advantage of this method is its flexibility. Various DEVICES can be installed which can be controlled by the operator him/herself. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 52 von 57 Date: 10/01/2013 • PVS o • • Creation of a request according to record type 6301 (at most times, a file is stored at the selection of a patient) DEVICE o The DEVICE is selected by the operator and the working mod of the device is started o Working with the DEVICE o (optional) creating of a result in form of record type 6310 PVS o 7.3.1 When the work with one patient is finished (e.g. exiting the medical documentation/file card, the existence of a record type 6310 is checked and added to the patient data, if existent. Result Same process as in 7.3. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 53 von 57 Date: 10/01/2013 7.4 Asynchronous communication Modern PVSs have the possibility to process and transmit GDT requests without having to wait for the results. Arriving result data is automatically accepted and processed by background utility programs which work in batch modes. • • Request new examination (record type 6302) o FK 8402 device and process specific characteristic map. This information is given per medical device o FK 8404 subcategory to FK 8402 (e.g. choice of an organ) o FK 8408 allocation of a Study-UID, so that several result files can be created for one examination (.e.g. creation of more than one image; record type 6310 exists multiple times) o FK 8409 allocation of an identifier (text) for one examination procedure o FK 8410 test identifier: Multiple test identifiers can be allocated in a series of tests o FK 8411 labeling of the tests o FK 8491 Referring physician (e.g. Dr. med. Doe/123456499) Transmission of examination data (record type 6310) o All fields from the previously created record type 6302 and optionally o FK 6325 labeling of the (partial) task (e.g. reference to a picture: later hand, hand AP axial) o FK 8412 file name of a result file (e.g. thumbnail-image) GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 54 von 57 Date: 10/01/2013 7.5 Asynchronous communication in equipment sharing As part of the construction and rationalization of equipment sharing, medical health care centers and laboratory joint practices, medical devices are used by multiple medical offices. Most of the time, the devices have their own rooms. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 55 von 57 Date: 10/01/2013 7.5.1 Process GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 56 von 57 Date: 10/01/2013 Multiple PVSs send an exanimation or treatment request to a central DEVICE. The DEVICE has a work list with pending processes. After the DEVICE has finished the processes, the medical offices need to be able to access the data again. 7.5.2 • Extensions of the GDT Necessity to generate globally individual labels for requested operations of a medical device as well as mapping the results. 7.5.3 Necessity of a definition for transmission paths As long as the data is only shared in an office’s own LAN (network), the data transmission can be freely defined via various transmission paths. As soon as the data leaves the office network, however, medical data protection (e.g. encryption) and other norms have to be considered to avoid an unnecessary complication of communication in heterogeneous networks. GDT- Gerätedatenträger, Version:3.0, Release 1.0 Seite 57 von 57 Date: 10/01/2013