ARCHETYPE Medical device (openEHR-EHR-CLUSTER.device.v1)

ARCHETYPE IDopenEHR-EHR-CLUSTER.device.v1
ConceptMedical device
DescriptionAn instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements.
UseUse to record the details of a medical device used in the provision of healthcare. Use of the term 'medical device' varies depending on context. Within the Standards world, the term device tends to refer to mechanical or electronic devices that support healthcare and require rigorous documentation regarding location tracking, maintenance, calibration, software versions etc. Within the terminology context the use of device is very broad, including any medical device that can be used in direct or indirect provision of clinical care, as long as it does not act in a way that exerts a direct pharmacological, metabolic or immunological effect. Examples of medical devices range from simple devices such as urinary catheters, tongue depressors, contact lenses, artificial joint implants, breast implants and plain dressings through to advanced devices such as artificial hearts, syringe drivers, spirometers, mobile phone applications and computerised devices that capture point-of-care medical measurements. In the complex situation where a surgically implanted device is used as the means to deliver therapeutic agents such as chemotherapy directly into the body, this archetype will be used to record only the details about the medical device itself and the order for medication and details about the actual administration of the therapeutic agent will be recorded using specific medication-related INSTRUCTION and ACTION archetypes. This archetype is designed to provide the framework for structured representation of any medical device and the data elements that are contained here are not specific for any one type of device. Single use devices will commonly require data elements such as Lot Number and Date of Expiry. In contrast these are usually not relevant for durable devices which will often have a set of identifiers, including a UID, Serial Number, Model etc. Further, different types of devices will require specific information relevant to their purpose. This data can be recorded using specific CLUSTER archetypes inserted into the 'Specific properties' SLOT. For example: use of a urinary catheter may require additional details about the diameter and length of catheter, material composition, number of lumens etc. If the medical device has a number of components that require recording of details, each individual component should be recorded explicitly by using an additional CLUSTER.device archetype inserted into the 'Components' SLOT. The data field 'Software Version' allows for only a single version to be recorded. This is primarily applicable for a device which is a software application. If the device has multiple software or hardware components that need to be specified, this should be done by using an addition CLUSTER.device inserted into the 'Components' SLOT. To record additional details for durable or persistent devices that relate to ownership, physical location tracking, maintenance schedules etc, use CLUSTER.device_details archetype inserted into the 'Asset management' SLOT in this archetype. This archetype has been designed for generic use within other archetypes that need to describe a device. Examples include: OBSERVATION.blood_pressure for the sphygmomanometer; OBSERVATION.ecg for the ECG machine; OBSERVATION.urinalysis for the reactent strips and the device used for testing; ACTION.procedure; and CLUSTER.exam_tympanic_membrane to detail the otoscope used.
MisuseNot to be used to record data about medicinal products that exert a direct pharmacological, metabolic or immunologic effect. For example: a medicine impregnated dressing that requires a prescription should be recorded using the INSTRUCTION.medication_order archetype, focused on the active ingredients, dosage etc.
PurposeTo record the details of a medical device used in the provision of healthcare.
ReferencesHL7 FHIR Resource - Device R0.0.82 DSTU1 [Internet]. Health Level Seven International; [accessed 2015 Feb 25]. Available from: http://hl7.org/fhir/DSTU1/device.html.

Guidelines for 64-bit Global Identifier (EUI-64) [Internet]. IEEE Standards Association [cited: 2015-02-25]. Available from: http://standards.ieee.org/regauth/oui/tutorials/EUI64.html.
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2010-06-29
Other Details LanguageAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2010-06-29
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=openEHR Foundation, references=HL7 FHIR Resource - Device R0.0.82 DSTU1 [Internet]. Health Level Seven International; [accessed 2015 Feb 25]. Available from: http://hl7.org/fhir/DSTU1/device.html. Guidelines for 64-bit Global Identifier (EUI-64) [Internet]. IEEE Standards Association [cited: 2015-02-25]. Available from: http://standards.ieee.org/regauth/oui/tutorials/EUI64.html., current_contact=Heather Leslie, Atomica Informatics, heather.leslie@atomicainformatics.com, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=D1349AAD9444365B34B1BAFDE9F0BD4A, build_uid=fdf1b399-f40d-488c-9a16-281daae7d28c, revision=1.1.4}
Keywordsdevice, machine, implant, appliance, catheter, prosthesis, aid, biomedical, instrument, equipment, meter, monitor, software
Lifecyclepublished
UIDdbd6f4b3-a3e6-41b1-a21e-3530ac1ca212
Language useden
Citeable Identifier1246.145.663
Revision Number1.1.4
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements., archetypeConceptComment=null, otherContributors=Tomas Alme, DIPS, Norway
Erling Are Hole, Helse Bergen, Norway
Vebjørn Arntzen, Oslo universitetssykehus HF, Norway (Nasjonal IKT redaktør)
Koray Atalag, University of Auckland, New Zealand
Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor)
Mate Bestek, 3fs, Slovenia
Lars Bitsch-Larsen, Haukeland University hospital, Norway
Diego Bosca, VeraTech for Health, Spain
Margaret Campbell, Queensland Health, Australia
Rong Chen, Cambio Healthcare Systems, Sweden
Bjørn Christensen, Helse Bergen HF, Norway
Stephen Chu, Queensland Health, Australia
Lisbeth Dahlhaug, Helse Midt - Norge IT, Norway
Samo Drnovsek, Marand ltd, Slovenia
Ivan Drvaric, NIJZ- National institute for public health of Slovenia, Slovenia
Shahla Foozonkhah, Iran ministry of health and education, Iran
Einar Fosse, National Centre for Integrated Care and Telemedicine, Norway
Mikkel Gaup Grønmo, FSE, Helse Nord, Norway (Nasjonal IKT redaktør)
Heather Grain, Llewelyn Grain Informatics, Australia
Grahame Grieve, Australia
Sam Heard, Ocean Informatics, Australia
Ingrid Heitmann, Oslo universitetssykehus HF, Norway
Anca Heyd, DIPS ASA, Norway
Tom Jarl Jakobsen, Helse Bergen, Norway
Gorazd Kalan, Outpatient pediatric care clinic, Slovenia
Lars Karlsen, DIPS ASA, Norway
Lars Morgan Karlsen, DIPS ASA, Norway
Daniel Karlsson, National Board of Health and Welfare, Sweden
Jeanette Krabbedal-Mathisen, Helse Bergen HF, Norway
Russell Leftwich, Russell B Leftwich MD, United States
Sabine Leh, Haukeland University Hospital, Department of Pathology, Norway
Heather Leslie, Atomica Informatics, Australia (openEHR Editor)
Vesna Levasic, Orthopaedic Hospital Valdoltra, Slovenia
Hallvard Lærum, Direktoratet for e-helse, Norway
Luis Marco Ruiz, Norwegian Center for Integrated Care and Telemedicine, Norway
Ian McNicoll, freshEHR Clinical Informatics, United Kingdom (openEHR Editor)
Bjoern Naess, DIPS ASA, Norway
Dave Nurse, Allocate Software, United Kingdom
Anne Pauline Anderssen, Helse Nord RHF, Norway
Rune Pedersen, Universitetssykehuset i Nord Norge, Norway
Živa Rant, National Institute of Public Health, Slovenia
Anoop Shah, University College London, United Kingdom
Thor-Einar Stemland, Helse Bergen, FOU Seksjon for e-helse, Norway
Micaela Thierley, Helse Bergen, Norway
Nils Thomas Songstad, UNN HF, BUK, Barneavdelingen., Norway
John Tore Valand, Haukeland Universitetssjukehus, Norway (Nasjonal IKT redaktør)
Nils Widnes, Helse-Bergen, Norway, originalLanguage=en, translators=
  • German: Anneka Sargeant, Institut für Medizinische Informatik - Universitätsmedizin Göttingen, anneka.sargeant@med.uni-goettingen.de
  • Swedish: Sofia Lång Janstad, Karolinska University hospital, Stockholm Region,, sofia.lang-janstad@regionstockholm.se
    Other Contributors: Sajjad Saffari Miandoab (Karolinska University hospital), Jörgen Kuylenstierna (openEHR Sverige), Josephine de Flon (Karolinska University hospital), Magnus Stridsman (Region Östergötland), Malin Larsson (Karolinska University hospital), Therese Högberg Mårder (Region Östergötland), Linda Rosen (Region Östergötland), Åsa Skagerhult (openEHR Sverige)
  • Spanish (Argentina): Alan March, Hospital Universitario Austral, Buenos Aires, Argentina, amarch@cas.austral.edu.ar, MD
  • Norwegian Bokmål: John Tore Valand, Helse Bergen HF
  • Portuguese (Brazil): Osmeire Chamelette Sanzovo, Hospital Sírio Libanês - SP, osmeire.acsanzovo@hsl.org.br
  • Arabic (Syria): Mona Saleh
  • French: Vanessa Pereira, Luxembourg Institute of Health (LIH), vanessapereira@protonmail.com
  • Dutch: Pieter Bos, Jelte Zeilstra, Nedap
, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={relationships=[], source=[], capabilities=[], activities=[], details=[], context=[], ism_transition=[], other_participations=[], data=[], credentials=[], target=[], items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Device name, description=Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device., comment=This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available. , uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=ELEMENT, level=1, text=Type, description=The category or kind of device., comment=Not applicable if a category is already recorded in 'Device name'. Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=ELEMENT, level=1, text=Description, description=Narrative description of the medical device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=SLOT, level=1, text=Properties, description=Further details about specific properties about the medical device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=ELEMENT, level=1, text=Unique device identifier (UDI), description=A numeric or alphanumeric string that is associated with this device within a given system., comment=Often fixed to the device as a barcode., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0004], code=at0004, itemType=ELEMENT, level=1, text=Manufacturer, description=Name of manufacturer., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=ELEMENT, level=1, text=Date of manufacture, description=Date the device was manufactured., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0020], code=at0020, itemType=ELEMENT, level=1, text=Serial number, description=Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=ELEMENT, level=1, text=Catalogue number, description=The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=ELEMENT, level=1, text=Model number, description=The exact model number assigned by the manufacturer and found on the device label or accompanying packaging., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, text=Batch/Lot number, description=The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, text=Software version, description=Identification of the version of software being used in the medical device., comment=When the medical device is an actual software application, record the version of the software using this data element. When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development)., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Date of expiry, description=Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging., comment=This date usually applies only to single use or disposable devices., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Other identifier, description=Unspecified identifier, which can be further specified in a template or at run time., comment=Coding of the name of the identifier with a coding system is desirable, if available., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Asset management, description=Further details about management and maintenance of the device., comment=For example: Owner, Contact details, Location, Network address, Date due for replacement, Calibration details etc., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.device_details.v1 and specialisations or
openEHR-EHR-CLUSTER.device_details.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=SLOT, level=1, text=Components, description=Additional structured informations about identified components of the device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.device.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0026], code=at0026, itemType=SLOT, level=1, text=Extension, description=Additional information required to capture local context or to align with other reference models/formalisms., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0027], code=at0027, itemType=SLOT, level=1, text=Multimedia, description=Digital representation of the device., comment=For example: a technical diagram of a device, or a digital image., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.media_file.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the device not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], content=[], description=[], contacts=[], state=[], events=[], provider=[], identities=[], protocol=[]}, topLevelItems={items=ResourceSimplifiedHierarchyItem [path=ROOT_/, code=at0000, itemType=CLUSTER, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=items, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Device name, description=Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device., comment=This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available. , uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=ELEMENT, level=1, text=Type, description=The category or kind of device., comment=Not applicable if a category is already recorded in 'Device name'. Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=ELEMENT, level=1, text=Description, description=Narrative description of the medical device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=SLOT, level=1, text=Properties, description=Further details about specific properties about the medical device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=ELEMENT, level=1, text=Unique device identifier (UDI), description=A numeric or alphanumeric string that is associated with this device within a given system., comment=Often fixed to the device as a barcode., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0004], code=at0004, itemType=ELEMENT, level=1, text=Manufacturer, description=Name of manufacturer., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=ELEMENT, level=1, text=Date of manufacture, description=Date the device was manufactured., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0020], code=at0020, itemType=ELEMENT, level=1, text=Serial number, description=Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=ELEMENT, level=1, text=Catalogue number, description=The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=ELEMENT, level=1, text=Model number, description=The exact model number assigned by the manufacturer and found on the device label or accompanying packaging., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, text=Batch/Lot number, description=The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, text=Software version, description=Identification of the version of software being used in the medical device., comment=When the medical device is an actual software application, record the version of the software using this data element. When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development)., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Date of expiry, description=Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging., comment=This date usually applies only to single use or disposable devices., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Other identifier, description=Unspecified identifier, which can be further specified in a template or at run time., comment=Coding of the name of the identifier with a coding system is desirable, if available., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Asset management, description=Further details about management and maintenance of the device., comment=For example: Owner, Contact details, Location, Network address, Date due for replacement, Calibration details etc., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.device_details.v1 and specialisations or
openEHR-EHR-CLUSTER.device_details.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=SLOT, level=1, text=Components, description=Additional structured informations about identified components of the device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.device.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0026], code=at0026, itemType=SLOT, level=1, text=Extension, description=Additional information required to capture local context or to align with other reference models/formalisms., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0027], code=at0027, itemType=SLOT, level=1, text=Multimedia, description=Digital representation of the device., comment=For example: a technical diagram of a device, or a digital image., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.media_file.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the device not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]