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世联翻译公司完成体连接器专业领域英文翻译
发布时间：2018-01-10 09:12 点击：
世联翻译公司完成体连接器专业领域英文翻译
Firmware Description
BodystikGeratherm Respiratory GmbHSection 1Basic Information1.1 LabelingFirmware name and version1.1.1 Embedded SWManufacturer: Geratherm Respiratory GmbHAddress: Sparkassenpassage 1, 97688 Bad Kissingen, GERMANYFW Name VersionBody 1.3.001.2 Level of ConcernThe Bodystik Firmware is a software system to perform lung function measurements. When we established the “level of concern”, the following aspects were taken into account:It could not immediately threaten the patient's or operator's life under plausible conditionsIt could not directly cause irreversible illness or permanent injury under plausible conditionsIt does not directly control (without operator intervention) delivery of energy, administration of parenteral drugs, or life-sustaining functionsIt does not provide a diagnosisIt provides information/data onlyCompetent health professionals would be reasonably expected to exercise judgment in the use of the information providedIt does not provide alarms for life threatening conditionsIt does neither consolidate nor obscure information or data that is available to the user in the predicate deviceThe treatment information provided will be verified and judged through various quality assurance proceduresFor the above mentioned reasons we classified this FW as moderate concern (Class B).1.3 Functional StructureSee attached document “PFBS0021R1 (Flussdiagramm embedded Software Bodystik.pdf)”1.4 Hardware RelationshipSee attached document “PFBS0020R3 (Tech. Dok. Blockschaltbild Bodystik).pdf“1.5 Operating EnvironmentThe environmental requirements depend on the workstation used and are specified for each platform individually.TECHNICAL SPECIFICATIONSProcessor Pentium III or greater, Minimum 1,6 GHz, recommended 2GHz or moreRAM Minimum 1GB for X86, 2GB for x64 or moreGPU DirectX 9-capable video card that runs at 1024 x 768 or higher displayresolutionMass Storage Minimum 3GBAudio -Monitor XGA (1024x768) or moreOS Windows XP or Windows 7Interfaces USB 1.1 or better1.6 Indication for useBodystik is used whenever measurement of lung function is required. This includes i.e. diagnosis of different lung diseases, expertises in occupational medicine, therapy control.1.7 ContraindicationThere is no contraindication for use of Bodystik embedded software.1.8 Approval HistoryBodystik was released by Geratherm Respiratory GmbH based on EC-Certificate issued by SLG, a Notified Body according to Annex XI of the Council Directive 93/42/EEC. Administration Class: IIb, The approval date is June, 22th, 2013 in EU.Bodystik is the first time to apply in China for CFDA approval. Administration Class: ⅡSection 2Implementation procedure2.1 Summary of software development specificationBodystik Version 1.3.00ITEM DescriptionProgramming language CDevelopment tools - AVR Studio 4 V4.18 Build 716- WinAVR Compiler version 20100110Methods - AVR Simulator V4.18 Build 716Product quantity of source code - Source code line: ~6,000Development personal Average of 2 developers over 7 years period.2.2 Risk managementSee attached document “ PFBS0014R1 (Masterfile Risikomanagement Bodystik).docx”2.3 Software Requirement SpecificationSee attached documents “lastenheft_body.pdf” and “pflichtenheft_body.pdf”2.4 Life cycleSee attached document “OPDE0001R1 (Softwareentwicklung).pdf2.5 Validation & VerificationSee attached documents “verifikation_bodystik.pdf” and “validierung_bodystik.pdf”2.6 Defect managementBugs are inevitable when writing complex software. No tool or methodology is known today which could guarantee the absence of bugs in large-scale software; therefore it is crucial to handle these issues properly during all stages of the product and project lifecycle in order to ensure the safety and effectiveness of the resulting device and to avoid the reoccurrence in future releases.For handling of embedded software defects see document “OPDE0002R1 (Hardwareentwicklung).pdf”Following tools support development in defect detection and elimination:- AVR SimulatorFor statistics of defects in different versions of the embedded software see attached document “Änderungsbericht Bodystik”.2.7 Revision historyDate SW Version Descriptions2011-03-04 1.0.01 First release2012-01-17 1.1.01 See attached document “Änderungsmitteilung V1.1.pdf”2012-10-12 1.1.81 See attached document “ Änderungsmitteilung V1.1.81.pdf”2013-02-08 1.2.01 development version – not approved2013-10-22 1.3.00 See attached document “ Änderungsmitteilung V1.3.00.pdf”For description of software change process and version releasing see attached document „ OPDE0001R1 (Softwareentwicklung).pdf”2.8 Clinical evaluationSee attached document “PFBS0018R1 (Nachweis klinische Bewertung Bodystik).pdf” and „PFBS0019R1 (Report of clinical evaluation Bodystik).pdf“Section 3Core AlgorithmSee attached documents “PFBS0022R1 (Beschreibung Embedded Software Bodystik).pdf”北京翻译公司,天津翻译公司,郑州翻译公司,西安翻译公司,重庆翻译公司,长沙翻译公司,济南翻译公司,青岛翻译公司,
