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神经传导速度测量仪

型号:NC-stat DPNCheck

糖尿病神经病变是糖尿病最常见的慢性并发症之一,病变可累及中枢神经及周围神经,以后者为常见。由于缺乏统一的诊断标准和检测方法,其患病率有较大差异,在10%~96%。NeuroMetrix公司开发的一款糖尿病神经病变检测装置(DPNCheck),其原理在于检测腓肠神经传导速度和振幅变化,腓肠神经作为远端感觉神经,是DPN神经传导变化的生物标记物,能很好的提示DPN变化情况,为糖尿病神经病变的早期筛查与诊断提供依据。
本体重量:
160g
外形尺寸:
5.5 cm x 19.0 cm x 11.6 cm

1、独家腓肠神经检查装置,与金标准有良好的相关性
腓肠神经检查装置DPNCheckNeuroMetrix公司研发,目前市面上无同类产品,产品具有独有的优势;DPNCheck与肌动电流描记器(神经传导检查金标准)比较具有良好的相关性,就敏感性和特异性方面,振幅敏感度88%、特异度94%,传导速度敏感度94%、特异度82%(如图1
                         
 
图1 DPNCheck与标准SNCV和SNAP测量方法相关性比较
 
2、独有的专利技术
该产品在中国、美国和澳大利亚等国均有取得专利,其中中国专利号CN201180055305.7(用于腓肠神经传导速度和振幅的自动化测量的装置和方法),美国专利号US9173581B2Apparatus and method for the automated measurement of sural nerve conduction velocity and amplitude),该技术普遍被学术专家接受并认可,其产品也在美国、欧洲、日本、加拿大、韩国及澳大利亚等国家批准上市;在英国谢菲尔德糖尿病神经病变培训计划中,指定作为培训使用产品。
 
3、定量且标准化的检测报告
通过在无神经病变的正常受试人员身上使用DPNCheck检测,从而获取腓肠神经传导反应的大规模数据库,根据腓肠神经的反应导出和振幅(Amp)及传导速度(CV)相关的正常界限值,一种是设定固定临界值:异常值 Amp 5μVCV 41m/s(无需输入年龄和身高即可使用),另一种根据AmpCV分别受年龄和身高影响,设定年龄和身高的临界值补偿,所以可以根据身高和年龄的差异,变动相应AmpCV的临界值(如图2)。
            
2 DPNCheck检测报告
A:固定临界值:异常值 Amp 5μVCV 41m/s
B:根据年龄和身高进行AmpCV临界值补偿
 
4DPNCheck小巧,使用方便快捷
神经传导速度检测装置DPNCheck无需特殊技术人员操作,使用简单(如图3),检查时间仅需3min即可完成,装置设计小巧、便携,适合临床门诊筛查,同时也适用于糖尿病病人的跟踪随访;整个检测过程无特殊器械和场所需要,满足并适用于各类医生需求。
 

                                                 

图3 DPNCheck装置检测腓肠神经示意图

 

Published Studies

Evaluation of Sural Nerve Automated Nerve Conduction Study in the Diagnosis of Peripheral Neuropathy in Patients with Type 2 Diabetes Mellitus (Archives of Medical Science, 2016)

 

Usefulness of the NC-stat DPNCheck Nerve Conduction Test in a Community Pharmacy as an Educational Tool for Patients with Diabetes (Canadian Pharmacists Journal, 2014)

 

Assessment of Diabetic Neuropathy Using a Point-of-Care Nerve Conduction Device Shows Significant Associations With the LDIFLARE Method and Clinical Neuropathy Scoring (Journal of Diabetes Science and Technology, 2014)

 

Reliability and Validity of a Point-of-Care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy (Plos One, Jan 2014)

 

Risk Factor Associations with Clinical Distal Symmetrical Polyneuropathy and Various Neuropathy Screening Instruments and Protocols in Type 1 Diabetes (Diabetes Research and Clinical Practice, 2011)

 

Clinical Outcomes of Electrodiagnostic Testing Conducted in Primary Care (Journal of the American Board of Family Medicine, 2010)

 

Repeatability of Nerve Conduction Measurements Derived Entirely by Computer Methods (Biomedical Engineering Online, 2009)

 

Multi-site Testing with a Point-of-Care Nerve Conduction Device Can Be Used in an Algorithm to Diagnose Diabetic Sensorimotor Polyneuropathy (Diabetes Care, 2008)

 

Utilization of Nerve Conduction Studies for the Diagnosis of Polyneuropathy in Patients with Diabetes: A Retrospective Analysis of a Large Patient Series (Journal of Diabetes Science and Technology, 2008)

 

Validation of a Novel Point-of-Care Nerve Conduction Device for the Detection of Diabetic Sensorimotor Polyneuropathy (Diabetes Care, 2006)

糖尿病患者

基本
参数
项目
参数
额定电压
3V
体积
5.5 cm x 19.0 cm x 11.6 cm
重量
160g
 
技术
参数
通道
2
CMRR (常规)
≥ 100 dB
增益
x977
噪声(常规)
< 2 µV rms
频率响应
(3 dB) 2 Hz – 2 kHz
采样频率
10 kHz
ADC分辨率
16比特(有效)
刺激器式恒定电流
单相
刺激器最大电压(常规)
420V
刺激器最大电流
100mA硬件,软件限制为70mA
刺激器最小脉冲宽度
100µS
刺激频率
1Hz(最大)
皮肤温度测定
非接触式,红外线
电池
3.0 Vdc 锂离子(CR123A
LCD显示
2位,7-
耐水性
IEC 529 IPX0不可进水
分类
BF 应用部分, IEC 60601-1

神经传导速度(m/sec)【CV】:兴奋度经由神经的速度
动作电位振幅(μV)【Amplitude】:兴奋度经由神经的大小

1.England et al. Distal symmetrical polyneuropathy: definition of clinical research. Muscle Nerve. 2005;31.
 
2.Dyck et al. Clinical and neuropathological criteria for the di agnosis and staging of diabetic polyneuropathy. Brain. 1985;108 (Pt 4).
 
3.Burke et al. Sensory conduction of the sural nerve in polyneuropathy. J Neurol Neurosurg Psychiatry. 1974;37.
 
4.Albers et al. Subclinical neuropathy among Diabetes Control and Complications Trial participants without diagnosable neuropathy at trial completion: possible predictors of incident neuropathy? Diabetes Care. 2007;30.
 
5.Dyck et al. Fiber loss is primary and multifocal in sural nerves in diabetic polyneuropathy. Ann Neurol. 1986; 19.
 
6.Veves et al. The relationship between sural nerve morphometric findings and measures of peripheral nerve function in mild diabetic neuropathy. Diabet Med. 1991;8.
 
7.Perkins et al. Glycemic control is related to the morphological severity of diabetic sensorimotor polyneuropathy. Diabetes Care. 2001;24.
 
8.Kizitan et al. Peripheral neuropathy in patients with diabetic foot ulcers: clinical and nerve conduction study. J Neurol Sci. 2007;258.
 
9.Charles, et al. Low peripheral nerve conduction velocities and amplitudes are strongly related to diabetic microvascular complications in type 1 diabetic: the EURODIAB Prospective Complication Study. Diabetes Care. 2010;33.
 
10.Lee et al. Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy. PLoS One. 2014; 22.
 
11.Olaleye D, Perkins BA, Bril V. Evaluation of three screening tests and a risk assessment model for diagnosing peripheral neuropathy in the diabetes clinic. Diab Res Clin Pract, 2001; 54(2):115-28.
 
12.Perkins BA1, Grewal J, Ng E, Ngo M, Bril V. Validation of a novel point-of-care nerve conduction device for the detection of diabetic sensorimotor polyneuropathy. Diabetes Care. 2006;29(9):2023-7.
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