厂商直销惠众国际富血小板血浆制备器OSP-10010,OSP-10015
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厂商直销惠众国际富血小板血浆制备器OSP-10010,OSP-10015
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 富血小板血浆制备器
管理类别 第三类
型号规格 OSP-10010 、 OSP-10015 、 OSP-11010 、 OSP-11110 、 OSP-22010 、 OSP-22110 、 OSP-11015 、 OSP-11115 、 OSP-22015 、 OSP-22115 、 OSP-11020 、 OSP-11120 、 OSP-22020 、 OSP-22120 、 OSP-11050 、 OSP-11150 、 OSP-22050 、 OSP-2215
结构及组成/主要组成成分 本产品由离心管和注射器嵌套组成，外套管为选配件，离心管和注射器均为中头型，由聚丙烯材料制成。产品经环氧乙烷灭菌，一次性使用。
适用范围/预期用途 本产品用于从人体自体血样中制备自体富血小板血浆（PRP），制备的自体富血小板血浆可在临床医生的指导下，用于骨折手术的辅助治疗。
一、工作原理 Working Principle
中文本产品采用嵌套式密闭离心分离结构。采集患者自体静脉全血并加入抗凝剂混匀后装入制备器，利用血液中红细胞、血小板、血浆各组分密度差异，通过梯度离心实现分层沉降；红细胞沉降至离心管底部，血小板富集于中层血浆区域。通过推拉嵌套内注射器，在全程密闭无菌体系下抽取富血小板血浆（PRP）。血小板内 α 颗粒可释放多种生长因子，用于促进组织修复、创面愈合。产品不含分离凝胶，无外源异物残留，保障血小板生物活性。
EnglishThis device adopts nested closed centrifugal separation structure. Collect patient autologous venous whole blood, mix with anticoagulant and fill into the kit. Based on density difference among red blood cells, platelets and plasma, gradient centrifugation realizes component stratification and sedimentation. Red blood cells settle at the bottom of the tube, while platelets concentrate in the middle plasma ｌayer. By pushing and pulling the nested inner syringe, platelet-rich plasma (PRP) can be precisely harvested in a fully closed sterile system.Alpha granules inside platelets release multiple growth factors to facilitate tissue repair and wound healing. No separation gel is contained, no foreign residue exists, so platelet biological activity is guaranteed.
二、产品功能 Functions
中文
容纳自体全血样本，配合通用医用离心机完成密度梯度离心分层；
嵌套密闭结构，在不开放管路前提下分离、提取富血小板血浆；
一套器械完成采血后分离、富集、抽取，简化术中样本转移流程；
多规格型号适配不同采血量，满足不同临床治疗剂量需求；
密闭操作降低血液样本暴露污染风险，维持血小板活性。
English
Hold autologous whole blood sample, cooperate with general medical centrifuge to complete density gradient stratification;
Nested closed structure enables separation and harvesting of PRP without opening fluid circuit;
Integrated device realizes separation, enrichment and extraction, simplifying intraoperative sample transfer;
Multiple specifications match different blood collection volume to satisfy various clinical dosage requirements;
Closed operation reduces contamination risk of blood sample and maintains platelet activity.
三、产品特点 Product Features
中文
密闭嵌套式设计：全程封闭式操作，减少血液与外界接触，降低污染风险；无分离凝胶，避免凝胶残留干扰组织修复；
国产标准化耗材：适配市场绝大多数常规台式医用离心机，无需采购专用设备；
多规格矩阵：10ml/15ml/20ml/50ml 多种容量可选，满足骨科、运动医学、创面修复不同场景；
操作流程简洁：标准操作全程 12–18 分钟，适合手术室、门诊日间治疗；
聚丙烯医用级材质，生物相容性良好；环氧乙烷独立无菌包装；
分层可控，血小板富集倍数稳定，批次间制备结果重复性；
鲁尔标准接口，提取完成可直接连接注射针进行病灶局部注射；
注册预期用途明确，合规用于骨科骨折手术辅助修复。
English
Closed nested design: full enclosed workflow minimizes blood exposure and contamination risk; free of separation gel to avoid residual interference on tissue repair;
Domestic standardized consumable, compatible with most common bench-top medical centrifuges on market, no dedicated equipment required;
Complete specification portfolio: 10ml/15ml/20ml/50ml options for orthopedics, sports medicine and wound care;
Simplified workflow: whole procedure lasts 12–18 minutes, suitable for operating room and outpatient day-case treatment;
Medical-grade polypropylene with good biocompatibility, individually EO sterile packed;
Controllable stratification, stable platelet concentration fold, consistent reproducibility between batches;
Standard Luer connector; PRP can be injected locally after harvesting by directly connecting injection needle;
Clear registered intended use, legally applicable for adjuvant repair in orthopedic fracture surgery.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品名称：富血小板血浆制备器 | Product Name: Platelet-Rich Plasma Preparation Kit |
| 型号系列：OSP-10010 / OSP-10015 / OSP-11010 / OSP-11015 / OSP-22010 / OSP-22015 | Model Series: OSP-10010 / OSP-10015 / OSP-11010 / OSP-11015 / OSP-22010 / OSP-22015 |
| 组成：离心管、嵌套式内注射器（外套管选配） | Composition: Centrifuge tube, nested inner syringe (outer tube optional) |
| 材质：医用聚丙烯 | Material: Medical-grade Polypropylene |
| 灭菌方式：环氧乙烷（EO） | Sterilization: Ethylene Oxide (EO) |
| 使用类型：一次性使用，禁止复用、二次灭菌 | Usage: Single-use only; reuse & resterilization prohibited |
| 适配设备：通用医用台式离心机 | Compatible Equipment: General bench-top medical centrifuge |
| 货架有效期：3 年 | Shelf Life: 3 years |
| 制备产物：自体富血小板血浆（不可静脉输注） | Output: Autologous PRP (Intravenous infusion forbidden) |
五、使用方法 Operation Instructions
中文
使用前核查外包装完整性、灭菌有效期，在无菌操作台内打开包装；
规范采集患者静脉自体全血，按比例添加抗凝剂，轻柔颠倒充分混匀，避免剧烈震荡造成血小板提前激活；
将混匀后的血液移入制备器离心管内，密封端口；平衡放置于离心机内，执行标准离心程序；
离心完成后平稳取出制备器，保持直立静置，严禁晃动扰动血液分层界面；
缓慢操作嵌套内注射器推杆，先抽取上层贫血小板血浆，再采集中层富血小板血浆，规避底层红细胞；
提取完成后可直接连接注射针头，尽快用于病灶局部注射；
使用完毕，所有接触血液的器械按照感染性医疗废弃物规范处置。
重要提示：制备完成的 PRP 建议 30 分钟内使用，不宜长时间存放。
English
Verify package integrity and expiry date before use; open package under sterile operating environment;
Collect patient autologous venous whole blood in standard procedure, add anticoagulant proportionally, invert gently for thorough mixing. Violent shaking which causes premature platelet activation should be avoided;
Transfer mixed blood into the centrifuge tube of the kit, seal port; balance and place into centrifuge, run standard centrifugation protocol;
Take out the kit steadily after centrifugation, keep upright and static. Do not shake to prevent disturbing blood stratification interface;
Operate the plunger of nested inner syringe slowly: first aspirate upper platelet-poor plasma, then accurately harvest middle-ｌayer PRP, avoid drawing bottom red blood cell ｌayer;
After harvesting, connect injection needle directly, apply for local lesion injection as soon as possible;
After operation, dispose all blood-contacting devices as regulated biohazard medical waste.
Important Note: Prepared PRP should be used within 30 minutes; long-term storage is not recommended.
六、适应症 Indications
中文本产品用于从人体自体血样制备自体富血小板血浆（PRP）。制备所得自体富血小板血浆，可在具备资质临床医师指导下，用于骨折手术的辅助治疗，促进骨组织修复愈合；拓展临床应用（遵循院内规范与诊疗指南）：运动软组织损伤、肌腱病、关节软骨损伤、慢性创面修复。⚠️ 严禁将制备的 PRP 用于静脉输注。
EnglishThe device is intended to prepare autologous platelet-rich plasma (PRP) from patient autologous blood samples.The obtained autologous PRP can be used under guidance of qualified clinicians for adjuvant treatment of fracture surgery to promote bone regeneration and healing;Extended clinical applications (comply with hospital protocols and clinical guidelines): sports soft tissue injury, tendinopathy, articular cartilage injury, chronic wound repair.⚠️ Intravenous infusion of prepared PRP is strictly prohibited.
七、禁忌症 Contraindications
中文
脓毒血症、采血区域存在活动性局部感染患者；
重度血小板减少症、严重凝血功能障碍、血小板功能异常人群；
已知对聚丙烯材料、抗凝药品存在严重过敏反应者；
血液系统恶性肿瘤、活动期恶性肿瘤患者；
重度贫血，不适合采集外周静脉血者；
妊娠、哺乳期患者需充分评估治疗风险后谨慎开展；
无法配合治疗、存在严重全身性基础疾病不耐受微创操作患者。
English
Patients with sepsis or active local infection at venipuncture site;
Severe thrombocytopenia, critical coagulation disorders or platelet dysfunction;
Patients with known severe allergy to polypropylene materials or anticoagulants;
Hematological malignant tumors or active malignant tumor patients;
Severe anemia patients unfit for peripheral venous blood collection;
Pregnant and lactating patients shall be treated cautiously after full risk assessment;
Patients unable to cooperate with treatment or suffering severe systemic disease intolerant to minimally invasive procedure.
八、注意事项 Precautions
中文
操作医师须经过 PRP 制备与再生医学相关规范化培训，全程严格执行无菌操作；
包装破损、漏气、超出灭菌有效期的产品禁止使用；
产品为一次性使用，禁止清洗、重复使用、二次环氧乙烷灭菌；复用会引发交叉感染、分离失效；
采血速度平缓，避免溶血；离心结束禁止剧烈摇晃制备器；
PRP 病灶局部注射使用，禁止静脉输注；
血液样本出现凝固时直接作废，不可继续分离操作；
禁止对抗凝剂、制备器结构私自改装；严格遵循推荐离心参数；
耗材储存远离高温、阳光直射，不要冷冻存放。
English
Operators must receive standardized training related to PRP preparation and regenerative medicine; strict sterile technique must be implemented throughout procedure;
Do not use products with damaged, leaking package or expired sterilization validity period;
Single-use device. Cleaning, reuse and secondary EO sterilization are forbidden; reuse may cause cross infection and separation failure;
Collect blood slowly to prevent hemolysis; violent shaking of kit after centrifugation is prohibited;
PRP is only for local lesion injection, intravenous transfusion is forbidden;
Discard blood specimen once clotting occurs, do not continue separation;
Unauthorized modification of anticoagulant or kit structure is prohibited; follow recommended centrifugation parameters strictly;
Store consumables away from high temperature and direct sunlight; freezing storage is forbidden.
九、存储条件 Storage Conditions
中文储存环境温度：10℃～30℃；相对湿度：30%～75%，环境无凝露；环境要求：干燥通风、无尘；避免阳光直射、挤压、撞击；远离腐蚀性气体、有机溶剂；产品保持原装密封包装，水平或直立存放，禁止冷冻；必须在货架有效期内使用，超过有效期严禁使用。
EnglishStorage Temperature: 10℃～30℃;Relative Humidity: 30%～75%, no condensation;Requirements: Dry, ventilated and dust-free; avoid direct sunlight, extrusion and impact; keep away from corrosive gas and organic solvents;Keep products in original sealed package, store horizontally or vertically. Freezing is prohibited;Use within shelf life; discard expired products.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
热门标签：厂商直销惠众国际富血小板血浆制备器OSP-10010OSP-10015,富血小板血浆制备器OSP-10010,惠众国际富血小板血浆制备器
