厂家碧迪动脉留置针20G/1.10mm x 45mm,货号682245
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厂家碧迪动脉留置针20G/1.10mm x 45mm,货号682245
桂经理19117326863微xin同号
桂经理19117326863微xin同号
动脉留置针BD Arterial Cannula
管理类别
第三类
型号规格
20G/1.10mm x 45mm
结构及组成/主要组成成分
动脉留置针由流量控制阀、针管把手、导管座、导管、保护套、硅胶管、排气接头、针管、不锈钢球、导引套管及导管套管组成。
适用范围/预期用途
产品用于动脉压监测及连续动脉血气的监测。
产品资质：国械注进 20153140035，第三类无菌一次性血管介入医疗器械，环氧乙烷灭菌，保质期 5 年
一、工作原理 Working Principle
中文
本品为针外套管式单腔动脉留置导管，穿刺阶段依靠 304 不锈钢穿刺针芯穿透桡动脉血管壁；针芯穿刺见回血确认血管位置后，推送前端 PTFE 聚四氟套管进入动脉管腔，随后撤出金属针芯，柔性套管留置于动脉内建立密闭血管通路。 配套一体化 Floswitch 单向流量控制阀（红色开关），机械结构实现通路通断控制，防止血液反流、漏血；导管尾端鲁尔锁接口可连接有创压力监测管路、血气采血注射器，通过密闭管路传递动脉实时压力波形，同时可密闭采集动脉血样本，全程无开放式血液暴露。 套管材质 PTFE 生物惰性强，与血管壁相容性高，降低血管刺激、血栓形成风险，实现短期持续动脉通路建立。
English
This product is an over-the-needle single-lumen arterial cannula. During puncture, the AISI304 stainless steel introducer needle penetrates the radial arterial wall. After blood flashback confirms intravascular position, the front PTFE catheter is advanced into the arterial lumen, then the ｍmbedl needle core is withdrawn, leaving the flexible catheter indwelling in the artery to establish a closed vascular access. It integrates an all-in-one Floswitch one-way flow control valve (red switch). The mechanical structure controls channel on/off to prevent blood backflow and leakage. The luer-lock hub at the catheter tail connects invasive blood pressure monitoring tubing and arterial blood gas syringes. It transmits real-time arterial pressure waveｆorms via closed tubing and collects arterial blood samples hermetically without open blood exposure. The PTFE catheter features high biological inertness and good vascular wall compatibility, reducing vascular irritation and thrombosis risk to establish short-term continuous arterial access.
二、产品功能 Product Functions
中文
有创连续动脉血压监测：留置套管连接压力传感器，实时传输动脉收缩压、舒张压、平均动脉压波形与数值；
密闭式连续动脉血气采样：无需反复穿刺动脉，开关控制阀即可多次采集动脉血，用于血氧、二氧化碳、酸碱值检测；
单向防反流通路管控：Floswitch 流量阀阻断血液逆向流出，减少血液渗漏、医护血源性病原体暴露风险；
穿刺后针芯安全收纳：撤出针芯时，针尖自动收纳于保护套内，杜绝针刺伤；
柔性双翼固定结构：两侧柔性固定翼配合敷料牢固粘贴皮肤，减少导管移位、弯折、脱出；
标准鲁尔锁通用接口：适配监护压力管路、血气注射器、冲洗肝素盐水管路，临床配件通用；
低刺激血管留置通路：PTFE 导管生物相容，短期留置减少动脉痉挛、内膜损伤、血栓并发症。
English
Invasive continuous arterial blood pressure monitoring: The indwelling catheter connects pressure transducers to transmit real-time waveｆorms and values of systolic, diastolic and mean arterial pressure.
Hermetic serial arterial blood gas sampling: Repeated arterial blood collection via flow valve without repeated arterial puncture, for detection of blood oxygen, carbon dioxide and pH value.
One-way anti-reflux channel control: The Floswitch valve blocks retrograde blood flow, lowering risks of blood leakage and occupational exposure to blood-borne pathogens.
Safety needle tip retraction after puncture: The sharp needle tip automatically retracts into protective sleeve upon withdrawal to eliminate needlestick injuries.
Flexible wing fixation design: Dual flexible wings adhere firmly to skin with dressings, minimizing catheter displacement, kinking and dislodgement.
Standard universal luer-lock hub: Compatible with monitoring pressure tubing, blood gas syringes and heparin saline flushing tubing for universal clinical accessories.
Low-irritation indwelling vascular access: Biocompatible PTFE catheter reduces arterial spasm, intimal injury and thrombotic complications during short-term indwelling.
三、产品特点 Product Features
中文
无 PVC、无 DEHP、无乳胶配方：导管及配件不含增塑剂、天然乳胶，适用于过敏体质、新生儿、重症敏感患者；
一体式 Floswitch 单向流量开关：集成于导管座，无需额外三通，一键控制通路，操作简化、密闭性更强；
红色针座 20G 可视化标识：红色底座快速区分 20G 规格，手术室、ICU 快速识别，避免耗材混用；
PTFE 聚四氟柔性导管：内壁光滑、摩擦系数低，推送顺滑；材质柔软贴合血管，降低动脉痉挛、血管损伤；
安全针尖防护系统：拔针自动收纳锐端，符合院感针刺伤防控规范，保护医护人员；
双侧柔性固定翼：轻薄柔软，粘贴舒适，长期留置不易牵拉、弯折导管；
独立 EO 环氧乙烷无菌包装：单支独立塑封，无热源、无菌，开箱即用，避免交叉污染；
45mm 加长套管：适配成人桡动脉穿刺深度，20G 内径 1.10mm，重力流速 49mL/min，满足监测、采血流量需求；
一次性使用杜绝交叉感染：不可重复灭菌复用，使用后统一医疗废物处理，降低血源性传染病传播风险。
English
PVC-free, DEHP-free, latex-free ｆormulation: Catheter and accessories contain no plasticizers or natural latex, suitable for allergic patients, neonates and critically ill sensitive populations.
Integrated Floswitch one-way flow valve: Built into catheter hub without extra stopcocks, one-touch channel control for simplified operation and superior hermetic sealing.
Visible red hub coding for 20G: Red base enables rapid size identification in OR and ICU, preventing wrong consumable usage.
Flexible PTFE catheter: Smooth inner lumen with low friction for easy advancement; soft material conｆorms to vessels to reduce arterial spasm and vascular injury.
Safety needle tip protection system: Sharp tip retracts automatically during needle withdrawal, complying with hospital infection control standards to protect clinicians from needlestick injuries.
Dual flexible fixation wings: Thin, soft and comfortable for skin adhesion, resisting catheter traction and kinking during prolonged indwelling.
Individual EO ethylene oxide sterile packaging: Single unit sealed pouch, non-pyrogenic and sterile for immediate use to avoid cross-contamination.
45mm extended catheter length: Matches radial artery puncture depth for adults; 20G inner diameter 1.10mm with gravity flow rate 49mL/min, meeting flow demands for monitoring and blood sampling.
Single-use only to eliminate cross-infection: Re-sterilization and reuse prohibited; dispose as regulated medical waste after use to reduce transmission risk of blood-borne infectious diseases.
四、技术参数 Technical Specifications
中文
产品型号 / 货号：REF 682245
规格尺寸：20G，导管内径 1.10mm，导管总长 45mm（1.77 英寸）
重力流速：49mL/min
结构组件：不锈钢穿刺针芯、PTFE 留置套管、一体式 Floswitch 单向流量阀、红色识别针座、双侧柔性固定翼、鲁尔锁尾端接口、针尖自动保护套
核心材质：
穿刺针：AISI304 医用不锈钢
留置套管：PTFE 聚四氟乙烯（无 PVC/DEHP）
针座 / 开关 / 固定翼：医用高分子，无天然乳胶
灭菌方式：环氧乙烷（EO）灭菌
无菌有效期：5 年
包装规格：25 支 / 内盒，500 支 / 整箱，单支独立无菌包装
防护结构：针芯撤出自动锐器收纳防护
认证资质：CE 2797 认证，国械注进三类医疗器械注册证
适用穿刺血管：成人桡动脉（主要）
使用限制：一次性使用，不可重复使用、重复灭菌BD
English
Model / Catalog Number: REF 682245
Size Specification: 20G, inner catheter diameter 1.10mm, total catheter length 45mm (1.77 inches)
Gravity Flow Rate: 49mL/min
Structural Components: Stainless steel introducer needle, PTFE indwelling catheter, integrated Floswitch one-way flow valve, red identification hub, dual flexible fixation wings, luer-lock distal connector, automatic needle tip protective sleeve
Core Materials:
Puncture Needle: Medical grade AISI304 stainless steel
Indwelling Catheter: PTFE (Polytetrafluoroethylene), PVC-free & DEHP-free
Hub / Valve / Wings: Medical polymer, natural latex-free
Sterilization Method: Ethylene Oxide (EO) gas sterilization
Sterile Shelf Life: 5 years
Packaging Standard: 25 units per inner box, 500 units per master carton; each cannula individually sterile packed
Safety Mechanism: Automatic sharp tip retraction upon needle withdrawal
Certifications: CE Certificate No.2797, Class III Import Medical Device Registration Certificate (China NMPA)
Primary Target Vessel: Adult radial artery
Usage Restriction: Single use only; re-use and re-sterilization prohibitedBD
五、使用方法 Operation Procedures
中文
（一）术前准备
核对产品货号、规格、灭菌有效期，检查独立包装无破损、漏气；
患者穿刺部位（桡动脉）皮肤严格消毒，铺无菌洞巾，评估 Allen 试验阳性确认侧支循环充足；
准备配套耗材：压力监测套件、肝素生理盐水冲洗液、血气采集注射器、无菌透明敷料；
操作者穿戴无菌手套、口罩，打开留置针无菌包装，取出产品，检查导管、开关、针芯无弯折、破损。
（二）动脉穿刺置管
舒展患者手腕，桡动脉充分暴露，定位动脉搏动最强点；
持留置针，针芯斜面向上，30°~45° 角度刺入皮肤，缓慢推进；
见针座内鲜红色回血，确认针尖进入动脉管腔；降低穿刺角度至 10°~15°，继续向前推送 PTFE 柔性套管；
套管完全送入血管后，固定针座，匀速拔出不锈钢针芯，针尖自动收纳至保护套内；
立即打开 Floswitch 流量阀，使用肝素盐水快速冲管，确认管路通畅无漏血。
（三）固定与管路连接
将两侧柔性固定翼平铺于患者皮肤，无菌透明敷贴完全覆盖针座、固定翼，牢固粘贴，避免牵拉；
鲁尔锁接口连接有创压力监测管路，拧紧锁扣防止脱落、漏液；
连接监护仪，校准压力零点，启动连续动脉血压监测；
如需采集血气样本：关闭监测管路三通，拨动 Floswitch 开关，密闭抽取动脉血，采样完成后肝素盐水冲管，恢复监测通路。
（四）留置维护与拔管
留置期间每 4 小时使用肝素盐水冲管，防止导管血栓堵塞；每日更换穿刺部位敷料，观察有无渗血、红肿、血管痉挛；
短期留置不超过 3~4 天，出现感染、血栓、血管剧烈痉挛立即拔除；
拔管操作：关闭流量阀，轻柔拔除 PTFE 套管，无菌纱布持续按压穿刺点 10~15 分钟，确认无出血后加压包扎；
使用完毕的留置针完整装入锐器盒，按医疗废物规范处置，严禁徒手接触针尖锐端。
English
(1) Pre-procedure Preparation
Verify catalog number, size and sterile expiry date; inspect individual pouch for intact seal without rupture or air leakage.
Perｆorm rigorous skin disinfection on radial artery puncture site, drape sterile fenestrated towel; confirm positive Allen test to ensure sufficient collateral circulation.
Prepare auxiliary supplies: invasive pressure monitoring kit, heparinized saline flushing solution, arterial blood gas syringes, sterile transparent adhesive dressing.
Clinician wears sterile gloves and mask, open cannula pouch and inspect catheter, flow valve and needle for kinks or damage.
(2) Arterial Puncture & Catheter Insertion
Extend patient’s wrist to fully expose radial artery, locate point of strongest arterial pulsation.
Hold cannula with needle bevel upward, penetrate skin at 30°~45° and advance slowly.
Bright red blood flashback in hub confirms needle tip inside arterial lumen. Lower puncture angle to 10°~15°, then advance the flexible PTFE catheter forward.
After full catheter insertion into vessel, stabilize hub and withdraw stainless steel needle core at constant speed; sharp tip retracts automatically into protective sleeve.
Immediately toggle open Floswitch flow valve, flush catheter rapidly with heparinized saline to confirm patent lumen without blood leakage.
(3) Securement & Tubing Connection
Lay dual flexible fixation wings flat on patient skin; cover hub and wings completely with sterile transparent dressing for secure adhesion to avoid traction.
Connect luer-lock hub to invasive blood pressure monitoring tubing, tighten lock fitting to prevent disconnection and fluid leakage.
Link tubing to patient monitor, calibrate pressure zero point and activate continuous arterial blood pressure monitoring.
Blood gas sampling procedure: Close monitoring stopcock, toggle Floswitch valve to draw arterial blood hermetically. After sampling, flush catheter with heparinized saline and restore monitoring channel.
(4) Indwelling Care & Catheter Removal
Flush catheter with heparinized saline every 4 hours during indwelling to prevent intraluminal thrombosis. Replace site dressing daily, inspect for bleeding, erythema and arterial spasm.
Short-term indwelling duration shall not exceed 3–4 days. Remove catheter immediately if infection, thrombosis or severe arterial spasm occurs.
Catheter removal: Close flow valve, extract PTFE catheter gently. Apply continuous compression on puncture site with sterile gauze for 10–15 minutes, then apply compressive dressing after confirming hemostasis.
Dispose used cannula entirely into sharps container per regulated medical waste protocols; bare hand contact with sharp needle tip is strictly prohibited.
六、适应症 Indications
中文
重症监护（ICU）患者：各类休克、多器官功能衰竭、严重创伤患者，需持续有创动脉血压实时监测；
围手术期高危手术患者：心胸外科、大血管、神经外科、大型腹部手术，术中术后连续动脉压监测；
需频繁、反复采集动脉血气标本的患者：呼吸衰竭、ARDS、机械通气患者，持续血气动态监测；
急救急诊危重患者：严重呼吸窘迫、心肺复苏术后、酸碱平衡紊乱患者，建立短期密闭动脉通路；
麻醉术中血流动力学不稳定患者：术中血压波动大、大量失血患者，实时动脉压力监测评估容量状态；
短期动脉给药通路（医嘱许可下）：重症急救动脉推注药物，替代反复动脉穿刺操作。
English
Critical Care (ICU) Patients: Patients with various shock, multiple organ failure and severe trauma requiring continuous real-time invasive arterial blood pressure monitoring.
Perioperative High-Risk Surgical Patients: Cardiothoracic, major vascular, neurosurgical and major abdominal surgeries with intra- and post-operative continuous arterial pressure monitoring.
Patients requiring frequent serial arterial blood gas sampling: Respiratory failure, ARDS and mechanically ventilated patients for dynamic continuous blood gas monitoring.
Emergency critically ill patients: Severe respiratory distress, post-cardiopulmonary resuscitation and acid-base disturbance patients requiring short-term closed arterial access.
Intraoperative hemodynamically unstable anesthetic patients: Patients with drastic intraoperative blood pressure fluctuation and massive hemorrhage, requiring precise real-time arterial pressure monitoring for volume status assessment.
Short-term intra-arterial medication access (per physician order): Intra-arterial emergency drug injection to replace repeated arterial punctures.
七、禁忌症 Contraindications
中文
穿刺部位绝对禁忌症：桡动脉穿刺区域皮肤急性感染、蜂窝织炎、脓肿、烧伤、大面积皮损；
血管条件禁忌症：Allen 试验阴性，手掌侧支循环缺失；严重桡动脉闭塞、重度动脉硬化、动脉血栓、雷诺氏病、严重血管痉挛疾病；
凝血功能障碍：严重凝血因子缺乏、活动性出血、血小板极低、未纠正的血友病、抗凝治疗后自发性出血高风险患者；
全身性感染失控：脓毒症休克伴穿刺部位潜在感染风险、全身性真菌感染未控制；
过敏禁忌症：对 PTFE、医用高分子、肝素、环氧乙烷灭菌残留物存在明确严重过敏史；
穿刺血管外伤 / 手术史：桡动脉既往外伤、血管修复手术、造瘘血管、前臂截肢残留血管；
无法配合留置护理患者：躁动、严重精神障碍，无法约束固定，存在导管自行拔除、出血风险；
长期留置需求：本品仅适用于短期动脉通路，需超过 4 天长期动脉监测者禁止使用。
English
Absolute contraindications at puncture site: Acute skin infection, cellulitis, abscess, burn and extensive skin lesion on radial artery puncture area.
Vascular condition contraindications: Negative Allen test indicating absent palmar collateral circulation; severe radial artery occlusion, advanced arteriosclerosis, arterial thrombosis, Raynaud’s disease and severe vasospastic disorders.
Coagulopathy disorders: Severe coagulation factor deficiency, active hemorrhage, severe thrombocytopenia, uncorrected hemophilia and patients with high spontaneous bleeding risk post-anticoagulation therapy.
Uncontrolled systemic infection: Septic shock with potential puncture site infection risk, uncontrolled systemic fungal infection.
Hypersensitivity contraindications: Confirmed severe allergy history to PTFE, medical polymers, heparin and EO sterilization residuals.
Vascular trauma / surgical history of target vessel: Prior radial artery trauma, vascular reconstructive surgery, arteriovenous fistula and residual vessel after forearm amputation.
Patients unable to cooperate with indwelling care: Agitated patients and those with severe psychiatric disorders who cannot be restrained and secured, carrying risk of self-extubation and hemorrhage.
Long-term access requirement: This cannula is only indicated for short-term arterial access; prohibited for patients requiring arterial monitoring longer than 4 days.
八、注意事项 Precautions
中文
（一）操作安全注意
本品为一次性无菌医疗器械，严禁重复使用、重复环氧乙烷灭菌，使用后按感染性锐器医疗废物处置；
穿刺前必须完成 Allen 试验，确认手掌双侧动脉侧支循环充足，避免桡动脉留置后手掌缺血坏死；
穿刺全程严格无菌操作，皮肤消毒范围直径≥8cm，消毒后充分干燥再行穿刺，降低导管相关血流感染风险；
穿刺力度轻柔，禁止暴力推送套管，防止动脉内膜撕裂、血管穿孔、皮下血肿；
针芯拔出后严禁再次将金属针芯回送入留置套管，金属锐器会切割 PTFE 导管造成导管断裂、血管异物；
Floswitch 流量阀仅单向通路管控，采血、冲管后必须确认阀门复位密闭，防止血液持续反流渗漏；
留置导管严禁扭曲、弯折、受压，敷料固定时避免管路牵拉，防止导管闭塞、血管撕裂出血。
（二）留置与临床监测注意
留置时长严格控制在 3~4 天内，超过时限血管感染、血栓、动脉闭塞风险大幅上升，需重新更换穿刺部位；
每 4 小时使用稀释肝素生理盐水规范冲管，冲管力度平缓，禁止高压暴力冲管，避免动脉血管损伤、气栓；
每日拆除敷料观察穿刺点，出现红肿、渗血、脓性分泌物、剧烈疼痛、手指发白发凉，立即拔除导管并对症处理；
血气采血时全程密闭操作，禁止管路开放暴露空气，防止动脉血液空气栓塞；采血后足量肝素盐水冲净管路内残留血液，预防血栓堵塞导管；
压力监测管路需每日校准零点，管路内无气泡，否则血压波形、数值失真，误导临床诊疗判断。
（三）储存、耗材与人员防护注意
储存环境严格避光、干燥、无尘，不可存放于高温、潮湿、化学消毒剂挥发区域，避免包装破损、材质老化；
开封后立即使用，无菌包装破损、漏气、灭菌有效期过期产品严禁临床使用；
操作全程佩戴医用手套，拔针、拔管时避免直接接触血液，操作后规范手卫生，预防医护血源性病原体感染；
肝素过敏患者，需更换无肝素生理盐水冲管方案，全程监测有无皮疹、瘙痒、过敏性休克等过敏反应；
本品仅适配成人桡动脉穿刺，禁止用于婴幼儿、儿童细小动脉穿刺，导管长度、管径不匹配易造成血管损伤、缺血并发症。
English
(1) Operational Safety Precautions
This product is a single-use sterile medical device. Reuse and re-sterilization with EO gas are strictly prohibited. Dispose as infectious sharps medical waste after use.
Allen test must be completed before puncture to confirm sufficient bilateral palmar collateral circulation, preventing hand ischemic necrosis after radial artery cannulation.
Strict aseptic technique throughout puncture procedure. Skin disinfection diameter ≥8cm; allow disinfectant to fully dry prior to puncture to reduce catheter-related bloodstream infection risk.
Perｆorm puncture gently; violent catheter advancement is forbidden to avoid arterial intimal laceration, vascular perforation and subcutaneous hematoma.
Never reinsert the ｍmbedl needle core back into the indwelling catheter after withdrawal; sharp ｍmbedl tip may cut PTFE catheter leading to catheter fracture and intravascular foreign body.
The Floswitch valve only provides one-way channel control. Confirm full valve closure after blood sampling and flushing to prevent continuous retrograde blood leakage.
Avoid twisting, kinking and compression of indwelling catheter; prevent tubing traction during dressing fixation to eliminate catheter occlusion and vascular laceration hemorrhage.
(2) Indwelling & Clinical Monitoring Precautions
Indwelling duration shall be strictly limited to 3–4 days. Exceeding this time ｆｆｆframe significantly elevates risks of vascular infection, thrombosis and arterial occlusion; re-puncture at alternative site is required.
Flush catheter with diluted heparinized saline every 4 hours with gentle pressure; high-pressure forceful flushing is prohibited to prevent arterial vascular injury and air embolism.
Remove dressing daily to inspect puncture site. Immediately extract catheter and provide symptomatic management if erythema, oozing blood, purulent discharge, severe pain or pale/cool fingertips are observed.
Perｆorm fully closed operation during arterial blood gas sampling; open tubing exposure to air is forbidden to prevent arterial air embolism. Flush residual blood from tubing completely with sufficient heparinized saline post-sampling to avoid intraluminal thrombotic occlusion.
Zero-calibrate pressure monitoring tubing daily and eliminate all air bubbles inside tubing; air bubbles distort blood pressure waveｆorms and readings, leading to misleading clinical diagnosis and treatment decisions.
(3) Storage, Consumable & Personnel Protection Precautions
Store product in light-proof, dry and dust-free environment. Do not store under high temperature, high humidity or volatile chemical disinfectant atmosphere to avoid pouch rupture and material aging.
Use cannula immediately after pouch opening. Do not clinically deploy cannulas with damaged/sealed pouches, air leakage or expired sterile shelf life.
Wear medical gloves during all procedures; avoid direct blood contact during needle and catheter removal. Perｆorm standardized hand hygiene post-operation to prevent clinician occupational infection from blood-borne pathogens.
For patients with heparin hypersensitivity, replace flushing solution with heparin-free normal saline. Continuously monitor for hypersensitivity reactions including rash, pruritus and anaphylactic shock.
This cannula is exclusively designed for adult radial artery puncture. Prohibit use on small arteries of infants and children; mismatched catheter length and gauge cause vascular injury and ischemic complications.
九、存储条件 Storage Conditions
中文
温度要求：长期存储环境温度范围 5℃ ~ 30℃；禁止存放于高于 40℃高温、低于 0℃冷冻环境；
湿度要求：环境相对湿度 30% ~ 75%，库房无凝露、无积水，防止无菌包装受潮破损；
光照要求：全程避光存储，远离阳光直射、紫外线消毒灯长期照射，避免高分子材质老化、包装印刷褪色；
环境洁净度：存储库房干燥通风、无尘、无腐蚀性气体（甲醛、酒精挥发、消毒烟雾），远离化学试剂、医用消毒剂堆放区域；
堆叠放置规范：产品整箱、内盒水平平放堆叠，禁止倒置、侧放、重压堆放；堆叠高度不超过 5 层，防止底层包装挤压破损；
仓储隔离要求：单独分区存放，不可与腐蚀性化学品、消杀药品、生活垃圾混放；
保质期存储标准：满足上述温湿度、避光、洁净条件下，环氧乙烷灭菌无菌有效期 5 年；存储环境不达标将缩短无菌有效期；
运输临时存储：运输过程全程防潮、防震、避光，避免雨淋、剧烈撞击、挤压；临时中转存储需遵循长期存储温湿度规范。
English
Temperature Requirement: Long-term storage ambient temperature range 5℃ ~ 30℃. Storage under temperature above 40℃ or below 0℃ freezing environment is prohibited.
Humidity Requirement: Ambient relative humidity 30% ~ 75%. No condensation or water accumulation in warehouse to prevent moisture damage to sterile packaging.
Light Requirement: Store in full light-proof condition; keep away from direct sunlight and long-term UV disinfection lamp irradiation to avoid polymer material aging and packaging print fading.
Environmental Cleanliness Requirement: Storage warehouse shall be dry, ventilated and dust-free, free of corrosive gas (ｆormaldehyde, alcohol vapor, disinfection fume). Keep separated from chemical reagents and medical disinfectant storage zones.
Stacking Standard: Lay master cartons and inner boxes horizontally for stacking. Inversion, lateral placement and heavy compression stacking are prohibited. Stack height shall not exceed 5 ｌayers to prevent extrusion rupture of bottom pouches.
Warehouse Isolation Requirement: Store in separate designated zones; mixing storage with corrosive chemicals, disinfection agents and domestic waste is forbidden.
Shelf Life Storage Standard: Under qualified temperature, humidity, light-proof and clean storage conditions, the EO sterilized sterile shelf life is 5 years. Unqualified storage environment shortens sterile validity period.
Temporary Transit Storage: Maintain moisture-proof, shock-proof and light-proof protection during transportation; avoid rain exposure, severe impact and extrusion. Temporary transit storage shall comply with long-term storage temperature and humidity specifications.
十、说明书核心总览 Core Manual Summary
中文
BD 碧迪 REF682245 动脉留置针为 20G/1.10mm×45mm 一次性无菌第三类血管介入器械，采用无 PVC、DEHP、乳胶 PTFE 柔性导管，配套一体式 Floswitch 单向流量控制阀与针尖自动安全收纳防护结构，适配成人桡动脉短期密闭动脉通路建立。 核心临床用途分为两项：连续有创动脉血压实时监测、多次密闭动脉血气样本采集，适用于 ICU 危重、围手术期高危、机械通气呼吸衰竭等血流动力学不稳定患者；穿刺前必须完成 Allen 试验评估手掌侧支循环，留置时长严格限制 3~4 天。 产品穿刺操作遵循无菌规范，见回血后推送套管、拔针自动收纳锐尖，通过柔性双翼敷料牢固固定；留置期间每 4 小时肝素盐水冲管，每日观察穿刺点有无感染、渗血、血管痉挛；出现穿刺部位感染、血管闭塞、凝血障碍、Allen 试验阴性者禁止使用本品。 本品独立 EO 环氧乙烷灭菌包装，无菌保质期 5 年，存储需避光、5~30℃、湿度 30%~75% 干燥无尘环境；一次性使用，使用后投入锐器盒按医疗废物处置，不可重复灭菌复用。 操作全程需防控针刺伤、空气栓塞、导管相关血流感染、动脉血肿 / 缺血坏死四大核心并发症，严格遵循无菌、冲管、监测、时限四大临床管理规范。
English
BD Arterial Cannula REF 682245 is a single-use sterile Class III vascular interventional device sized 20G/1.10mm×45mm. It features PVC-free, DEHP-free and latex-free flexible PTFE catheter, integrated Floswitch one-way flow control valve and automatic sharp needle tip retraction safety mechanism, indicated for short-term closed arterial access establishment via adult radial artery. Two core clinical applications: continuous real-time invasive arterial blood pressure monitoring and repeated hermetic arterial blood gas sampling. It is suitable for hemodynamically unstable patients including critically ill ICU patients, perioperative high-risk surgical patients and mechanically ventilated respiratory failure patients. Allen test must be perｆormed prior to puncture to evaluate palmar collateral circulation; indwelling duration shall be strictly limited to 3–4 days. Aseptic technique is mandatory for puncture procedure. Advance catheter after blood flashback; sharp tip retracts automatically upon needle withdrawal, secured firmly by flexible wings and transparent dressing. Flush catheter with heparinized saline every 4 hours during indwelling; inspect puncture site daily for signs of infection, bleeding and vasospasm. This cannula is contraindicated for patients with puncture site infection, arterial occlusion, coagulopathy and negative Allen test result. Each cannula is individually EO ethylene oxide gas sterilized with a 5-year sterile shelf life. Storage requires light-proof, dry and dust-free environment with temperature 5~30℃ and relative humidity 30%~75%. Single-use only; dispose of used cannula in sharps container per medical waste regulations, re-sterilization and reuse are prohibited. Four key major complications shall be prevented throughout all procedures: needlestick injuries, air embolism, catheter-related bloodstream infection and arterial hematoma / hand ischemic necrosis. Clinical management shall strictly comply with four core specifications: aseptic operation, standardized catheter flushing, daily clinical monitoring and controlled maximum indwelling duration.
以上产品详情仅供参考，上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理!The above product details are for reference only. Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical products. All products are sourced from respective manufacturers, agents and distributors. Please contact us in case of any infringement, and we will handle it promptly.
热门标签：厂家碧迪动脉留置针20G/1.10mm,x,45mm货号682245,碧迪动脉留置针,留置针682245
