Micro-syringe as a result of the high frequency of clinical use, direct contact with patients, the failure of its equipment will have a direct impact on the patient's disease status. Researchers in this paper, by simulating the test fluid, electrical safety testing and analysis of statistical methods such as maintenance records, consider six kinds of common injection pump, in terms of performance, safety and the failure rate of three performance. Compared the performance analysis, summarized the various types of injection pump characteristics, researchers make suggestions to clinical departments, equipment procurement and equipment management departments for usage and improvement.
Equipment Failure ; Equipment Safety ; Syringes

This paper introduces the meaning of YY0709-2009's issue and its scope. It emphasizes the details of visual and audible alarms. Reasonable suggestions to comply with these requirements are provided at the end of the article. It will be of help to understand YY0709-2009 and to manufacture or test the product under YY0709-2009.
Equipment Failure ; Equipment and Supplies ; Quality Control

Theories of classified management which are based on risk governance are introduced into the newly revised , but the punishments on the manufacturers of unconformity products are not classified based on the severity and risks caused by the test items. This article analysed the disadvantages of current punishment measures on the manufacturers of unconformity products and the theoretical basis of classified punishments. The feasibility of classified punishments had also been studied and some basis of discretionary punishments was provided under the current regulations.
Equipment Failure ; Equipment and Supplies ; standards ; Punishment

This article elaborates electromagnetic compatibility of medical electrical equipment and the regulatory tests based on related standards. And elaborating the diversity and the necessity of rectification by specific cases and deeply discussing and summing up for improving the compatibility of medical electrical equipment.
Electricity ; Electromagnetic Fields ; Equipment Failure ; Equipment and Supplies

The article introduces the clinical testing method for the product of patient monitor, the definition of direct measurement and indirect measurement method, and the different testing methods. The clinical testing methods for none invasive blood pressure, pulse oxygen saturation and ECG analysis have significant value, which are important solutions to test the safety and effectiveness of medical devices by using the equivalent analysis method. These methods above are also provided as reference for other medical devices' clinical testing.
Equipment Failure Analysis ; Equipment Safety ; Equipment and Supplies ; standards ; Humans

In an effort to overcome the drawbacks of distraction osteogenesis using the Ilizarov external fixator, intramedullary lengthening devices have been developed and applied for long bone distraction osteogenesis. Several successful cases have been reported, leading to the next generation of distraction osteogenesis. However, intramedullary lengthening devices have their own problems, such as device failure, difficulty of control of the lengthening degree. The authors report on a case of device failure during distraction osteogenesis using ISKD(R) (Orthofix Inc.) in the distraction phase, and the strategy that involved switching to a lengthening over nail system, which uses the Ilizarov external fixator, in order to obtain the target length.
Equipment Failure ; Equipment Failure Analysis ; External Fixators ; Osteogenesis, Distraction*

This paper provides introduction and analysis of common malfunctions of ventilators System from the aspect of an engineer in the hospital, with a focus on feasible solutions to malfunctions.
Equipment Failure ; Maintenance ; Ventilators, Mechanical

According to the structural characteristics of spiral CT systems and our experiences, some relevant solutions to common malfunctions in daily maintenance are suggested.
Computers ; Equipment Design ; Equipment Failure ; Equipment Failure Analysis ; methods ; Humans ; Maintenance ; Tomography, Spiral Computed ; instrumentation

This paper discusses the test method of auditory alarm in YY0709-2009 by analyzing the test requirement and process. Consider of the acoustic theory and the problem during the test, it provides some suggestions for improvement.
Acoustics ; Clinical Alarms ; Equipment Failure ; Equipment Safety ; methods

In this paper, the common errors in medical devices test reports are classified and analyzed. And then the main 11 influence factors for these inspection report errors are summarized. The hierarchy model was also developed and verified by presentation data using MATLAB. The feasibility of comprehensive weights quantitative comparison has been analyzed by using the analytic hierarchy process. In the end, this paper porspects the further research direction.
Equipment Failure Analysis ; Equipment and Supplies ; standards ; Models, Theoretical