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1、Project name:Homecare Muti-parameter Recorder (H10)Document name:Risk management reportWritten: Date:Auditor: Date:Approved: Date:Revision RecordVer.Revision descriptionReviserDateTable of ContentsTable of Contents- 2 -Chapter1 Summary- 3 -Chapter2 Category- 4 -Chapter3 General Introduction- 6 -3.1
2、Product Overview- 6 -3.2 Intended Use- 6 -3.3 Composition- 6 -Chapter4 Members and Responsibility of Risk Management- 7 -Chapter5 Determination of Safety Characteristics- 8 -Chapter6 Summarization of the Risk Management- 12 -Chapter7 Evaluation of the Residual Risk- 31 -Chapter8 Completeness Evaluat
3、ion of Risk- 32 -Chapter 9 Information updating and risk management after manufacturing- 33 -Appendix A. Analysis method- 34 -A.1Harm analysis method- 34 -A.2 Risk estimate method- 34 -Appendix B. Analysis Method- 35 -B.1 Estimation of the severity of each hazard- 35 -B.2.Estimation of the likelihoo
4、d of each hazard- 36 -B.3.Estimation of the acceptability of each risk- 37 -Appendix CAbbreviations used- 38 -Appendix DContents of Tables- 39 -Chapter1 SummaryStandard informationStandardISO14971:2012NameMedical devices-Application of risk management to medical devicesTest product informationNameHo
5、mecare Muti-parameter RecorderModelH8ConfigurationMainframe,BP cuff,SpO2 sensor, ECG cable and electrodes,Android PadPhotoH8ConclusionAll known or foreseeable hazards have been analyzed. After carrying out corresponding risk control measures, have not introduced any new hazards, and there are no ALA
6、RP or N/ACC risk, so the risk/benefit analysis is not necessary.Fail itemNothingRemarkNothingChapter2 Category2.1 CategoryThis document is established according to standard ISO14971:2012 the risk management for medical devices. The goal is to systematically carry out the effective management of the
7、various risk processes for the companys R&D and manufacture of Homecare multi-parameter recorder, The document is the instructive direction for design, confirmation, production and sales, and for CE authentication, FDA authentication and SFDA authentication constituent.2.2 Relative supporting docume
8、ntItemStandardDescription1MDD 93/42/EECMedical Devices Directive: COUNCIL DIRECTIVE 2007/47/EC of 5 September 2007 concerning medical devices2ISO 780:1997Packaging Pictorial marking for handing of goods3EN 980:2008Terminology, symbols and information provided with medical devices-Graphical symbols f
9、or use in the labeling of medical devices4EN 1041: 2008Terminology, symbols and information provided with medical devices-Information supplied by the manufacturer with medical devices5IEC/TR 60878:2015Graphical symbols for electrical equipment in medical practice6EN ISO 13485: 2012Medical devices Qu
10、ality Management Systems Requirements for Regulatory Purposes7EN ISO14971: 2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)8EN ISO 14155: 2011Clinical investigation of medical devices for human subjects Good clinical practice9EN I
11、SO10993-1: 2009/AC:2010Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management(ISO10993-1:2003)10IEC 62133:2012 RLVSecondary cells and batteries containing alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary cells, and fo
12、r batteries made from them, for use in portable applications11EN 62304:2006/AC:2008 Medical devices - software-software lifecycle processes12EN 62366:2008Medical devices-Application of usability engineering to medical devices13EN ISO 81060-1:2012Non-invasive sphygmomanometers - Part 1: General requi
13、rements and test methods for non-automated measurement type14EN 1060-3:1997 +A2:2009Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems15EN 1060-4:2004Non-invasive sphygmomanometers-Part 4: Test procedures to determine the overa
14、ll system accuracy of automated non-invasive sphygmomanometer16IEC 60601-1：2005+A1：2012Medical electrical equipment; Part 1: General requirements for basic safety and essential performance17EN IEC 60601-1-2: 2007Medical electrical equipment Part 1: General requirements for safety -2 Collateral stand
15、ard: Electromagnetic compatibility - Requirements and tests18IEC 60601-1-6: 2010Medical electrical equipment-Part 1-6:General requirements for basic safety - Collateral Standard: Usability19EN 60601-2-47:2001Medical electrical equipment - Part 2-47: Particular requirements for the safety, including
16、essential performance, of ambulatory electrocardiographic systems20IEC 60601-2-49: 2011Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment21IEC 80601-2-30: 2009+AMD1:2013 CSVMedical electrical equipment Part 2-30: Particular
17、requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers22ISO 80601-2-61: 2011Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentChapter3 General Introduction3.1 Product
18、OverviewZTE homecare multi-parameter recorder is mainly composed of host recorder(H8),3-Lead ECG cable, blood pressure cuff and SPO2 probe which for monitoring the physiological data of ECG,SPO2 and NIBP at home. It can realize data transmission between the H8 and the android Pad through the unique
19、data transmission interface. Moreover, The recorder equipped transmission and realize users registration and users historical data records. The equipment operating system customized for android 4.4.2 system, elaborate design is easy to operate and carry.3.2 Intended UseThis recorder is mainly used i
20、n household mode, intended use for measuring the physiological data of elder people, provide a convenient measurement of electrocardiogram (ECG),SPO2 and non-invasive blood pressure. Provide reference data for the doctor and clinical diagnosed.3.3 CompositionThe homecare multi-parameter recorder inc
21、ludes the following components: Power supply module, Display module, User interface, Signal collection & process module, Control module, and NIBP module, , ECG module, SpO2 module.Chapter4 Members and Responsibility of Risk ManagementMemberDepartmentPositionResponsibilitySignatureDirectorResearch an
22、d development departmentTechnology managerBe responsible for planning, approval and application of risk management report.MemberResearch and development departmentmanagerAnticipate the activities of planning, writing, evaluation and application of risk management report.Research and development depa
23、rtmentengineerProvide information and experiences from the viewpoint of technology;Anticipate the activities of risk analysis and review; Review the activities of risk management;Provide risk control methods in the viewpoint oftechnology.Manufacture departmentmanagerProvide information and experienc
24、es from the viewpoint of manufacturing;Anticipate the activities of risk analysis and review; Review the activities of risk management;Provide risk control methods in the viewpoint ofmanufacturing.Market departmentmanagerProvide information and experiences from the viewpoint of product control, sale
25、 and after sale service;Anticipate the activities of risk analysis and review; Review the activities of risk management;Provide risk control methods in the viewpoint ofproduct control, sale and after sale service.Quality department Quality directorAnticipate the activities of risk analysis and revie
26、w;Verification the effect of risk management methods.Quality department Test operator(When necessary) test product.Chapter5 Determination of Safety CharacteristicsTable 1 Qualitative and quantitative analysis of the characteristicsNoSafety-related characteristics that could have impact on safetyYes/
27、NoSafety-related characteristics identification1What is the intended use and how is the medical device to be used?Yes Condition: The homecare multi-parameter recorder can be used in home, lab environment.Intended use: The H10 used in household mode, intended use for measuring the physiological data
28、of elder people, provide a convenient measurement of electrocardiogram (ECG), SPO2 and non-invasive blood pressure. Provide reference data for the doctor and clinical diagnosed.Patient: AdultMethod: SpO2 Measuring Range: 0%100%. HR: 20bpm300bpm. NIBP Measuring range: SBP 40270mmHg(Adult)DBP 10215mmH
29、g(Adult) Pmean 20235mmHg(Adult)User/operator: clinicians and home-care operators are users of the device. 2Is the medical device intended to be implanted?NoThe recorder is for non-invasive use only.3Is the medical device intended to contact the patient or other persons?YesThe cuff/sensor/electrode c
30、ontact the patients skin.Working mode: the contact consists of short-term contact (one contact or multiple contacts range(s) within 24 hours) and long-term contact (one contact or multiple contacts accumulated range(s) between 30days and 25 hours).4What materials or components are incorporated in th
31、e medical deviceYesABS, Terylene, stainless steel, silicone, coupling gel- 8 -or are used with, or are in contactwith, the medical device?5Is energy delivered to or extracted from the patient？YesThe recorder delivers energy of light and electricity to the patient.6Are substances delivered to or extr
32、acted from the patient?No7Are biological materials processed by the medical device for subsequent re-use, transfusion ortransplantation?NoNo biological materials processed.8Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controlsapplicabl
33、e?NoThe SpO2 sensor, cuff ,ECG probe should be cleaned before use.9Is the medical device intended to be routinely cleaned or disinfected by the user?YesThe device shall be cleaned if it is regarded as necessary for the hospital regulations.10Is the medical device intended to modify the patient envir
34、onment?NoThe medical device isnt intended to modify the patient environment.11Are measurements taken?YesDuring measurement, if sensor/cuff isimproperly placed, it may affect the accuracy of the measurement results.12Is the medical device interpretative?YesHomecare multi-parameter recorder provides t
35、his function.In the measurement, the device captures the blood pressure information, blood saturation information, pulse rate information, ECG signal , thus obtaining the BP values, SpO2 values, PR values, ECG waveform.13Is the medical device intended for use in conjunction with other medical device
36、s, medicines or other medical technologies?NoThe device shall not be used in conjunction with other medical devices.Advice not used with defibrillator or MRI equipment.14Are there unwanted outputs of energy or substances?YesThere may be unwanted outputs of energy under the fault conditions, e.g., le
37、akage current.15Is the medical device susceptible to environmental influences?YesIn the allowable range, temperature, humidity and atmospheric pressure have no effect on themeasurement results. But the patient movement may affect the measurement results.The measurement is susceptible to strong elect
38、ricalinterference, such as power-line and electrical static.16Does the medical device influence the environment?YesThe system may generate unexpected EMI17Are there essential consumables or accessories associated with the medical device?YesSpO2 sensor, cuff, ECG cable and electrodes18Is maintenance
39、or calibration necessary?No19Does the medical device contain software?YesThe device contains embedded software.20Does the medical device have a restricted shelf-life?YesThe material aging, will lost asepsis function.21Are there any delayed or long-term use effects?e.g., ergonomics and accumulativeef
40、fects.YesLong time SpO2 measurement will make patient feeling uncomfortable due to the raising temperature inside the clips.22To what mechanical forces will the medical device be subjected?YesThe device will be subjected to unexpected impact, vibration, dropping or crushing.23What determines the lif
41、etime of the medical device?YesCorrect operation and good maintenance24Is the medical device intended for single use?No25Is safe decommissioning or disposal of the medical device necessary?YesAccord with local environment safeguard.26Does installation or use of the medical device require special tra
42、ining?YesThe user need to read user manual for correct operation.27How will information for safe use be provided?YesThe information for safe must be provided.28Will new manufacturing processes need to be established or introduced?NoNow throughput meets requirement.29Is successful application of the
43、medical device critically dependent/on human factors such as the userinterface?29.1Can the user interface design features contribute to use error?YesThe user need to read user manual and familiar with the user interface.29.2Is the medical device used in anenvironment where distractions can cause use
44、 error?YesTo be used in an un-allowed environment, may cause use error.29.3Does the medical device have connecting parts or accessories?Yes SpO2 sensor, cuff, Temperature probe, ECG cable and electrodes.29.4Does the medical device have a control interface?YesThe device is controlled by operating the buttons.29.5Does the medical device display information?NoThe device displays the information including physiological parameters like SpO2 value,BP value, PR value, etc., an
