资源描述
XXX Co., LtdCE Tech ni cal FileXXX Co., LtdClinical Evaluation Report7Product Name:Model No.:Docume nt No.:Versio n:Date :Date :Date :Complied by :Reviewed by:Authorized by:Content1. General details 32. Description of the product and its intended use 32.1 Intended use: 32.2 Contraindication 32.3 Description of the product ( see the form below) 33. The background of clinical evaluation and selection of clinical data models43.1 The R&D of the product background 53.2 Range of cli ni cal evaluati on 103.3 Overview of the cli nical evaluati on phase 103.4 Cli ni cal evaluati on of pers onnel qualificati ons 114. Information retrieval process 124.1 Range of information retrieval 125. Analysis of clinical data 135.1 Evaluati on of product performanee 135.2 Security evaluation 175.3 Devices of clinical literature evaluation 185.3 Product docume nts and manuals 395.4 Equivale nt device s adverse events (see the form belo.w)396. Conclusions 411. General detailsThe O-Wave I produced by XXX Co., Ltd, it main utilizes the en ergy gen erated by the sole noid drive actuate bullet body in side therapeutic han dle, so that the impact of the bullet body to pulse collid ing the therapeutic head, the acoustic pulse will be con verted to the exact ballistic shock wave, have a good therapeutic effect for musculoskeletal disorder and other. The product mainly con sists of host, Therapeutic han dle (therapeutic head) and foot switch, which hosts in clud ing upper and lower case, power supply, main board and touch screen. Accessories include power line, handwriting pen, handle bottom case, keys and aluminium alloy suitcase. Supplies accessories include silicone cap and therapeutic head. The product main models: OCE-ESWT-001 (double-end )、OCE-ESWT-002 (single-end) ; power requirement:100-240V AC , freque ncy: 50/60Hz.2. Description of the product and its intended use2.1 Intended use:The O-wave I used in the area of adjuva nt therapy of chronic joint pain and muscular pain.2.2 Contraindicationa) Pregnant women and women menstrual period, person with sensitive skin, heart disease, abnormal blood pressure, malig nant tumors, cerebrovascular patie nts , patie nts with acute disease or other pers on treated by doctor must con sult a doctor rear can use this product.b) It is contrain dicated for use by those who has a skin perceptual disturba nee or is not sen sitive about the heat.c) It is not permitted to give children or people who were no ability to express consciousness to use.d) It is prohibited to use when bathing, sweating and sleeping.2.3 Description of the product(see the form beloWProductMainmodelsStructural compositionPerformance specificationOutside drawingOCE-ESWT-001(double-e nd)Main con sists of host, therapeutichan dle(therapeutic head) and* Liquid crystal display (LCD) scree n800 480* Power:AC100V-240V 50/60Hz* Freque ncy: 1-16HZOCE-ESWT-002(sin gle-e nd)foot switch, which hosts including upper and lower case, power supply, main board, touch screen and so on. Treatme nt en ergy: 60-185mJ Output power: MAX: 300VA Uptime: 17-19s Work ing curre nt: within 3.2-1.1A Size: 290mmx240mmx130mm Weight:2.07kg Width of Electric lmpulse:20- 400 Heating Temperature: 40 C -48 C Shelf-life: the minimum service lifeof the complete machine is 2,000,000 times (calculation in accordance with n umber of strokes)The mi ni mum service life of each therapeutic head is 150,000 times (calculati on in accorda nce with n umber of strokes) There are two therapeutic handle and one foot switch* Liquid crystal display (LCD) scree n800 480 Power:AC100V-240V 50/60Hz* Freque ncy: 1-16HZ* Treatme nt en ergy: 60-185mJ* Output power: MAX: 300VA* Uptime: 17-19s* Work ing curre nt: within 3.2-1.1A* Size: 290mmx240mmx130mm* Weight:2.07kg* Width of Electric Impulse:20- 400 s* Heating Temperature: 40 C -48 C Shelf-life: the minimum service lifeof the complete machine is 2,000,000 times (calculation in accordance with n umber of strokes)The mi ni mum service life of each therapeutic head is 150,000 times (calculati on in accorda nce with n umber of strokes)* There is a therapeutic han dle and a foot switch3. The background of clinical evaluation and selection of clinical data models3.1 The R&D of the product backgroundThe in vitro shock wave therapy apparatus utilizes liquid electrical en ergy conversion and tran sferprin ciple, caus ing it to produce an amount of gradie nt differe nee and tors ion differe nee betwee n differe nt tissue den sity, and result ing in crack ing bone lysis, loose n adhesi ons, stimulate microvascular rege nerati on, promote bone formati on and so on, to reach to the purpose of the treatme nt of disease. The electromag netic wave utilizes sole noid coil and the powerful electromag netic filed gen erated un der the actio n of electric en ergy, gen erates repelle ncy magn etic field by means of the in verse in duct ion act on the dielectric film, and the electromag netic en ergy refracts to ballistic and gen erates flat shock waves after it has met the dielectric film, and the n by the con cave lens the acoustic lens focuses the shock wave and in troduced into the local area in n eed of treatme nt.The O-Wave I produced by our compa ny main utilizes the en ergy gen erated by the sole noid drive actuate bullet body in side therapeutic han dle, so that the impact of the bullet body to pulse collidi ng the therapeutic head, the acoustic pulse will be con verted to the exact ballistic shock wave, have a good therapeutic effect for musculoskeletal disorder and other. Its treatme nt characters main have followi ng aspects:a) Street effect:The shock wave can through the body fluid and tissue to the affected area, and when it enters the body, due to it con tact with differe nt media, such as fat, tendon s, ligame nts and other soft tissues and bone tissues, the in terface of differe nt acoustic impeda nee tissues will produce differe nt mecha nical stress and the performa nee of the orga ni zati on have differe nt ten sile and compressive stresses. The ten sile stress can con tribute to in ter-tissue release, promote micro-circulati on; the compressive stress can con tribute to the elastic deformati on of cells, in crease cell oxyge n uptake, so as to achieve therapeutic purpose.b) Cavitati on effect:The negative band pressure of pulse tail to the shock wave can cause the cavitation effect. When the pressure by the hydrody namic force field is lower tha n liquid saturated vapor pressure, the molecules in the liquid will enter cavitation reacted core, and allowed to expand into a size can be observed, which is a cavitati on effect. The cavitatio n effect is unique characteristics of the shock wave, which is con ducive to clear the occlusion tiny blood vessels, loosen adhesions joint and soft tissue.c) An algesic effect:The local high-i nten sity shock wave can gen erate super stimulate to n erve endings tissue, block ing pain conduction of information to the cerebral cortex; the shock wave can cause radical changes in surrounding cells and release suppressed pain substa nces, so as to achieve therapeutic purposes an algesia.d) Catabolite activati ng effect:Through the promotion of growth factors and stem cell generation, the shock wave can promote local blood circulation and improve tissue local membrane permeability, can speed up organic metabolism, relieve affected part of in flammatory react ion and speed up tissue heali ng.With the developme nt of scie nee and tech no logy as well as inno vati on and applicatio n of the shock wave therapy apparatus, after investigation, the applied analysis for chronic pain treatment to in vitro shock wave is as follows: Treatme nt objects and applied rangeIndication: the patient who has chronic soft tissue injury pain and goes through general physiotherapy, medicati on, partial closure in effective, such as subacromial bursitis, in flammati on of long tendon of biceps muscle, calcified suprasp in atus tendin itis, internal humeral epic on dylitis, lateral epic on dylitis, sn app ing hip, jump kn ee, calca neody nia and pla ntar fasciitis, III type of prostatitis, etc.Contraindication: severe systemic disease, severe heart disease, hypertension, cardiac pacemaker, hemorrhagic disease, coagulation disorders, children under 14 years of age and pregnant women. The local factors in clude in fectious active stage, skin burst, tendon and fascia acute injury, pathologic fractures, atrophy and infectious bone ununion, shock wave focus in the brain and spinal tissue, lung tissue, and large blood vessels, the place walk ing at importa nt nerve trun k, jo int fluid leakage.After gen eral physiotherapy, medicati on, partial closure in effective in patie nts with chronic soft tissue injury pain disorders, such as: subacromial bursitis, biceps tendinitis, the calcific tendinitis post, humeral epic on dylitis, humerus epic on dylitis, sn app ing hip, jump ing kn ee, heel pain and pla ntar fasciitis; 川 type of prostatitis.Contraindication: severe systemic disease, severe heart disease, hypertension, cardiac pacemaker, bleedi ng disorders, coagulatio n disorders, childre n un der 14 years of age and preg nant wome n. Local factors include active infection, skin ulceration, tendons and fascia acute injury, pathologic fractures, atrophy and infected nonunion, the shock wave focus in the brain and spinal cord tissue, lung tissue, and large blood vessels, an importa nt n eural stem traveli ng at who were the releva nt sect ion of fluid leakage. Applicati on of chro nic pain treatme nt to in vitro shock wave1)Treatme nt of calca neody niaThe calca neody nia is one of the more com mon cli ni cal problems of many elderly chromic in tractable diseases. Mainly for heel pain, and associated with active or passive activity limitation, most accompanied by the prese nee of heel spurs. The in vitro shock wave as a new treatme nt; it can be applied by many scholars because of pain reduct ion and crack ing calcific sedime nt, and have achieved good results. The Ogde n and other are un der the support of the America n Food and Drug Adm ini strati on (FDA), first adopt ran dom, con trastive and double bli nd methods to do a prospective study to calca neod ynia of in vitro shock wave; the use of in vitro shock wave gen erator to patie nts are 320 cases, the medical history is range from 6 mon ths to 18 years, after 3 mon ths treatme nt group of success rate is 56% greater tha n con trol group, so the calca neody niabecomes the first to the shock wave treatme nt of orthopedic disease to be approved by FDA.There are in cludi ng Guan gli ng Huang and other 40 cases of elderly calca neody nia patie nt of in vitro shock wave treatme nt, 37 cases were completed 6 mon ths of follow-up, after 8 weeks of treatme nt, 12 weeks and 6 mon ths of effective rate respectively is 62% (23 cases)、70 % (26 cases and 84 % (31 cases) , the excelle nt rate respectively is 35 % (13 cases)、43 % (16 cases) and 54 % (20 cases) . Hongqian Zhu and other utilize high en ergy in vitro shock wave to treat calca neody nia patie nts, and there are 84 cases; after 3 mon ths of treatme nt, the excelle nt rate is 84%. Tongfa Liao and other adopt the CAS 2012A9 electromag netic type of shock wave produced by Suzhou to treat 60 cases of calcaneodynia patients, 58 cases of follow-up, the effective rate is 70%; it was not found obvious complicati on after treatme nt. Hua Chang and other adopt the in vitro shock wave therapy apparatus produced by Germa ny to treat calca neody nia patie nt, the effective rate is 47.9% after treatme nt.2) Treatme nt of lateral epic on dylitis and scapulohumeral periarthritisThe lateral epic on dylitis, also known as tennis elbow, com mon symptoms are pain limited mobility and muscle atrophy and so on. Treatment is based on relieve pain, loosen adhesions. Conventional non-surgical treatme nt methods are non-steroidal an ti-i nflammatory drugs, ultraso und therapy, local steroid inject ions, physical therapy and laser therapy and so on, but the effects were not sustained and the affirmative. Extracorporeal shock wave in recent years has been used to treat tennis elbow and achieved good results. Clinical application of extracorporeal shock wave therapy related to tennis elbow, domestic and overseas scholars have done a lot of research. An war and other adopt Germa ny PIEZOSON100 electric - hydraulic type extracorporeal shock wave therapy device to treat tennis elbow, calca neody nia and rotator cuff injury, and in total 116 cases, the treatme nt effect was observed. Tennis elbow treatme nt was found 72.4% display rate and 18.4% efficie ncy, the effect is not obvious 9.2%; rotator cuff injury showed 25.0% excelle nt rate and 42.0% efficie ncy, and 33.0% in effective 33.0%.Loew and other 195 cases treatme nt history of joint diseases is more than a year and is in valid for conven ti onal physical therapy and block ing therapy patie nt, X-ray showed all patients parts have calcified shadow at least the diameter of 1.5cm.After the treatment of high-energy in vitro shock wave have 12 times, 58% of the patie nts have bee n effectively alleviated, local calcificati on was also sig ni fica ntly reduced. Yangeng Xing and other adopt extracorporeal shock wave to treat tennis elbow, shoulder and heel pain, after 826 mon ths of follow-up, in the tennis elbow of ESW group of 102 cases, there are 89 cases of excelle nt efficacy, 11 cases of com mon efficacy, 2 cases in vain, the efficacy rate of 87.2%; in the scapulohumeral periarthritis of ESW group of 95 cases, there are 77 cases of excellent efficacy, 15cases of com mon efficacy, 3 cases in vain, the efficacy rate of 81.0%. There are in clud ing Xiaru Zheng and other 20 cases of scapulohumeral periarthritis patie nts applied to in vitro shock wave treatme nt, the cure rate reaches to
展开阅读全文