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厂商西京一次性使用血液回收耗材XJ-13-05等规格
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厂商西京一次性使用血液回收耗材XJ-13-05等规格
桂经理19117326863微xin同号
型号规格 型号：XJ-13-05型；规格：225mL、125mL。型号：XJ-13A-05型；规格：225mL、125mL。型号：XJ-13B-05型；规格：2500mL。型号：XJ-13C-05型；规格：XYG
结构及组成/主要组成成分 本产品由血液回收装置、贮血滤血器、吸引管三部分组成，不包含任何药物成分。血液回收装置由连接管路、分离杯、回收袋及废液袋组成；贮血滤血器由贮血筒盖、贮血筒、过滤网、消泡网和出口管组成；吸引管由双管组件、流量调节器、瓶塞穿刺器和Y型三通组成。环氧乙烷灭菌。
适用范围/预期用途 本产品需与XJ-12-05型自体血液回收机组合使用，是用于外科手术出血量400mL以上患者自体血液的收集、过滤、分离、清洗和回输的一次性使用无菌医疗器械。
一、工作原理
Working Principle
中文本耗材为一次性无菌密闭管路系统，需与 XJ-12-05 型自体血液回收机配套使用。通过负压吸引将手术创面失血吸入管路，与抗凝剂按比例混合防凝；经贮血滤血器（含过滤网、消泡网）初步过滤，去除血凝块、组织碎屑、气泡。血液进入分离杯后，在主机高速离心作用下按密度分层：红细胞沉积于杯底，血浆、游离血红蛋白、抗凝剂、脂肪滴、炎性因子等杂质被分离至废液袋；再经生理盐水洗涤净化，最终高纯度浓缩红细胞收集至回收袋，通过管路回输患者，实现自体血回收再利用。
EnglishThis product is a disposable sterile closed-circuit system, used exclusively with XJ-12-05 Autologous Blood Recovery Machine. Surgical blood loss is aspirated into the tubing via negative pressure suction, mixed with anticoagulant proportionally to prevent coagulation. It is pre-filtered through a blood storage filter (with filter mesh and defoaming net) to remove clots, tissue debris, and air bubbles. Blood enters the separation bowl and is stratified by density under high-speed centrifugation: red blood cells (RBCs) sediment at the bottom, while impurities (plasma, free hemoglobin, anticoagulant, fat droplets, inflammatory factors) are separated into the waste bag. After saline washing and purification, high-purity concentrated RBCs are collected in the recovery bag and reinfused into the patient, achieving autologous blood recovery and reuse.
二、产品特点
Product Features
中文
全密闭无菌设计：环氧乙烷灭菌，一次性使用，全程无开放环节，杜绝交叉感染。
分级过滤系统：贮血滤血器配多层过滤网（40–150µm）+ 消泡网，高效去除杂质与气泡。
双规格适配：分离杯容量 125mL/225mL，适配不同出血量手术，匹配主机离心参数。
抗凝混合：双管同步设计，抗凝剂与血液按比例混合，防凝效果稳定。
高效分离收集：分离杯结构优化，红细胞回收率高，废液与纯净红细胞分区收集。
安装便捷：管路预连接，与主机匹配度高，快速完成安装与排气，缩短术前准备时间。
兼容性强：专为 XJ-12-05 型血液回收机设计，适配其全自动 / 半自动操作流程。
English
Fully Closed Sterile Design: EO sterilized, single-use, no open links throughout, prevents cross-infection.
Multi-stage Filtration System: Blood storage filter with multi-ｌayer mesh (40–150µm) + defoaming net, efficiently removes impurities and air bubbles.
Dual-spec Adaptation: Separation bowl capacities 125mL/225mL, fit surgeries with different blood loss, match host centrifugal parameters.
Precise Anticoagulant Mixing: Dual-tube synchronous design, anticoagulant and blood mixed proportionally, stable anticoagulation effect.
Efficient Separation & Collection: Optimized separation bowl structure, high RBC recovery rate, separate collection of waste and purified RBCs.
Easy Installation: Pre-connected tubing, high compatibility with host, fast priming and air removal, shortens preoperative preparation.
Strong Compatibility: Designed exclusively for XJ-12-05 Blood Recovery Machine, adapts to its automatic/semiautomatic operation.
三、技术参数
Technical Parameters
项目 Item 参数 Specification
型号规格 Model & Specification XJ-13-05 型，分离杯容量：125mL、225mL
结构组成 Composition 吸引管、贮血滤血器（2500mL）、血液回收装置（分离杯、回收袋 1000mL、废液袋 10000mL、连接管路）
灭菌方式 Sterilization 环氧乙烷（EO）灭菌，无菌有效期 3 年
过滤精度 Filtration Accuracy 40–150µm（贮血滤血器）
抗凝混合比例 Anticoagulant Mix Ratio 1:5–1:7（可调节）
管路材质 Tubing Material 医用 PVC，无增塑剂，生物相容性好
最大负压耐受 Max Negative Pressure ≤-80kPa
适用主机 Compatible Host XJ-12-05 型自体血液回收机
包装规格 Packaging 单套独立无菌包装
四、使用方法
Instructions for Use
中文
术前检查：检查包装完整性、灭菌标识及有效期，确认无破损、过期。
安装准备：打开包装，取出耗材，连接主机管路接口，安装分离杯、回收袋与废液袋。
管路排气：启动主机排气程序，用生理盐水或抗凝剂充盈管路，排尽气泡，确认管路通畅无漏液。
抗凝设置：根据手术需求，设置抗凝剂流量（1:5–1:7），确保混合均匀。
血液回收：连接吸引头至手术创面，开启主机负压，血液经吸引管→贮血滤血器→分离杯，自动完成过滤、离心、洗涤、收集。
回输操作：浓缩红细胞收集完成后，通过主机控制回输，全程监测管路状态，避免气泡、扭曲。
术后处理：手术结束，停机，断开所有管路，耗材按医疗废物规范处理；清洁主机接口。
全程无菌操作，严禁复用，避免管路受压、弯折、刺破。
English
Preoperative Check: Inspect package integrity, sterilization label, and validity; ensure no damage or expiration.
Installation: Open package, take out consumables, connect to host tubing ports, install separation bowl, recovery bag, and waste bag.
Tubing Priming: Start host priming procedure, fill tubing with saline or anticoagulant, remove all air bubbles, confirm patency and no leakage.
Anticoagulant Setting: Set anticoagulant flow (1:5–1:7) per surgical needs, ensure uniｆorm mixing.
Blood Recovery: Connect suction probe to surgical site, activate host negative pressure; blood flows through suction tube → blood storage filter → separation bowl, with automatic filtration, centrifugation, washing, and collection.
Transfusion: After concentrated RBC collection, reinfuse via host control; monitor tubing status to avoid air bubbles and kinking.
Postoperative Handling: Stop machine, disconnect all tubing, dispose consumables as medical waste; clean host ports.
Maintain aseptic technique; single-use only; avoid tubing compression, kinking, or puncture.
五、适应症
Indications
中文与 XJ-12-05 型自体血液回收机配套，适用于外科手术出血量≥400mL患者的自体血液收集、过滤、分离、清洗、回输，减少异体输血需求：
骨科、心血管、普外科、神经外科、产科、创伤等大出血手术
术中预计出血量较大、需节约用血的手术
稀有血型、异体输血过敏或宗教信仰拒绝异体输血患者
EnglishUsed with XJ-12-05 Autologous Blood Recovery Machine, indicated for autologous blood collection, filtration, separation, washing, and reinfusion in patients with surgical blood loss ≥400mL, reducing allogeneic transfusion needs:
Massive bleeding surgeries in orthopedics, cardiovascular, general surgery, neurosurgery, obstetrics, trauma
Surgeries with expected large blood loss requiring blood conservation
Patients with rare blood types, allogeneic transfusion allergy, or religious ｏbjections to allogeneic transfusion
六、禁忌症
Contraindications
中文
血液被恶性肿瘤细胞、脓液、细菌、真菌、羊水、粪便严重污染者。
回收血液含大量骨水泥、化学药物、冲洗液、有毒物质。
败血症、菌血症、全身感染未控制患者。
血液系统疾病、** 凝血功能障碍、严重贫血（Hb＜60g/L）** 未纠正者。
耗材包装破损、灭菌失效、过期者严禁使用。
胸腹腔开放性损伤超过 4 小时者。
新生儿、婴幼儿及无法耐受自体血回输的特殊患者。
English
Blood severely contaminated by malignant tumor cells, pus, bacteria, fungi, amniotic fluid, feces.
Recovered blood containing large amounts of bone cement, chemicals, irrigation fluid, toxic substances.
Patients with uncontrolled sepsis, bacteremia, systemic infection.
Patients with hematological diseases, coagulation disorders, severe anemia (Hb <60g/L) uncorrected.
Do not use if consumable package is damaged, sterilization invalid, or expired.
Patients with open thoracic/abdominal injuries >4 hours.
Neonates, infants, and special patients intolerant to autologous transfusion.
七、注意事项
Precautions
中文
专业医护人员在无菌条件下操作，严格遵循主机与耗材使用规程。
一次性使用，严禁复用；使用前必须检查包装完整性、灭菌标识及有效期。
安装时确保管路连接牢固、密封，避免气泡、漏液、扭曲、受压。
排气必须，回输前确认管路无气泡，防止空气栓塞。
回收血液不得常温放置超 4 小时，处理后尽快回输。
禁止接触尖锐物品，防止管路、分离杯破损；避免阳光直射与高温。
与主机配套使用，不得与其他品牌血液回收机混用，确保兼容性与安全性。
术中实时监测主机报警，异常立即停机，排查耗材与管路问题。
术后耗材按医疗废物处理，不得随意丢弃，防止污染环境。
English
Operated only by professional medical staff under aseptic conditions; strictly follow host and consumable protocols.
Single-use only; no reuse; inspect package integrity, sterilization label, and validity before use.
Ensure secure, sealed tubing connections during installation; avoid air bubbles, leakage, kinking, and compression.
Complete priming to remove all air; confirm no air bubbles before transfusion to prevent air embolism.
Do not store recovered blood at room temperature for >4 hours; reinfuse promptly after processing.
Avoid sharp ｏbjects to prevent tubing/bowl damage; protect from direct sunlight and high temperature.
Use exclusively with designated host; do not mix with other brands to ensure compatibility and safety.
Monitor host alarms in real time; stop immediately for troubleshooting on abnormality.
Dispose consumables as medical waste postoperatively; do not discard randomly to avoid environmental contamination.
八、存储条件
Storage Conditions
中文
环境要求：温度 5℃～40℃，相对湿度≤80%，通风干燥，无腐蚀性气体、粉尘，远离火源与电磁干扰。
避光防潮：避免阳光直射、雨淋、潮湿，防止包装破损与灭菌失效。
堆放要求：平放，避免重压、摔跌、剧烈震动，防止管路扭曲、分离杯变形。
有效期：环氧乙烷灭菌，无菌有效期 3 年，按包装标注日期使用。
运输条件：温度 - 10℃～+40℃，避免剧烈震动、挤压、雨淋。
English
Environment: Temperature 5℃–40℃, relative humidity ≤80%, ventilated and dry, free of corrosive gases and dust; keep away from fire and electromagnetic interference.
Light & Moisture Protection: Avoid direct sunlight, rain, and humidity to prevent package damage and sterilization failure.
Stacking: Lay flat; avoid heavy pressure, dropping, and severe vibration to prevent tubing kinking and bowl deｆormation.
Validity: EO sterilized, 3-year sterile validity; use within labeled date.
Transportation: Temperature -10℃–+40℃; avoid severe vibration, extrusion, and rain.
九、说明书核心信息（中英文）
Manual Core Inｆormation
中文
产品名称：一次性使用血液回收耗材
型号规格：XJ-13-05 型，分离杯 125mL、225mL
结构组成：吸引管、贮血滤血器（2500mL）、血液回收装置（分离杯、回收袋 1000mL、废液袋 10000mL、管路）
灭菌方式：环氧乙烷灭菌，无菌有效期 3 年
适用范围：与 XJ-12-05 型血液回收机配套，用于出血量≥400mL 外科手术自体血回收、过滤、分离、清洗、回输
禁忌症：血液污染、感染、恶性肿瘤、凝血障碍、耗材过期 / 破损等
安全提示：一次性使用、无菌操作、严禁复用、全程密闭、防气泡防漏液
存储运输：5℃～40℃，干燥通风，避免重压震动
有效期：耗材无菌有效期 3 年，按包装标注使用
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
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