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厂家供应麦瑞通囊袋压迫止血器SGF1A,SGF1AC,SGF1V,SGF1VC
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厂家供应麦瑞通囊袋压迫止血器SGF1A,SGF1AC,SGF1V,SGF1VC
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
SGF1A，SGF1AC，SGF1V，SGF1VC
结构及组成/主要组成成分
由止血器和注射器组成。
适用范围/预期用途
囊袋压迫止血器在术后即刻对封闭的手术部位（包括起搏器和 ICD 囊袋）提供压迫。
1 工作原理 Working Principle
中文本产品为气囊式机械压迫装置，配套注射器向压迫球囊内充入空气，球囊膨胀产生可控的外部压力，直接作用于起搏器 / ICD 等闭合术后囊袋创面；通过均匀外部压迫，减少囊袋腔隙、抑制创面渗血、促进组织贴合，实现术后囊袋局部止血，减少血肿形成风险。产品不依赖药物止血，为纯物理机械压迫机制Merit Medi...。
EnglishThis device is a balloon‑type mechanical compression system. The supplied syringe injects air into the compression balloon to generate controllable external pressure. The inflated balloon applies uniｆorm compression onto closed surgical pocket wounds (pacemaker / ICD pockets). Mechanical pressure reduces dead‑space of the pocket, inhibits oozing, promotes tissue apposition and achieves local hemostasis to lower hematoma risk. It provides purely physical compression without pharmacological hemostatic agentsMerit Medi...。
2 功能 Function
中文
心脏起搏器、ICD 植入术后即刻，对闭合的手术囊袋部位提供可控的外部压迫；
减少囊袋渗血，降低术后囊袋血肿发生概率；
带透明视窗，无需移除装置即可观察局部伤口状况；
可调节气囊充气量，实现压迫压力可控；
分为自粘胶款与魔术贴绑带款，适配不同皮肤条件患者Merit Medi...。
English
Deliver controllable external compression on closed surgical pocket sites immediately after pacemaker or ICD implantation surgery.
Reduce pocket oozing and decrease postoperative pocket hematoma incidence.
Transparent observation window allows wound assessment without device removal.
Adjustable balloon inflation volume enables controllable compression force.
Available in pressure‑sensitive adhesive version and hook‑and‑loop strap version for varied skin conditionsMerit Medi....
3 产品特点 Product Features
中文
一次性无菌使用，环氧乙烷灭菌，不含天然乳胶；
压迫球囊上方配置透明可视窗口，不拆除止血器即可观察伤口渗血、皮肤状态；
充气管末端配置单向充气阀，维持气囊内压力，防止漏气；
两种固定形式：A 系列为压敏自粘固定；V 系列为无胶魔术贴绑带固定；
AC/VC 为 Cool 降温款，具备冷敷辅助效果；
配套专用注射器，充气操作便捷，压力可微调；
整体柔性材质，贴合胸壁体表轮廓，提升佩戴舒适度Merit Medi...。
English
Single‑use sterile device, ethylene oxide sterilized, natural‑rubber‑latex‑free.
Clear transparent window over compression balloon enables wound and skin inspection without removing device.
One‑way inflation valve at fill‑tube end maintains balloon pressure and prevents air leakage.
Two fixation options: Series‑A: pressure‑sensitive self‑adhesive fixation; Series‑V: adhesive‑free hook‑and‑loop strap fixation.
AC / VC are Cool variants with adjunct cooling effect.
Matching dedicated syringe for convenient inflation and fine pressure adjustment.
Flexible construction conｆorms to chest‑wall contour for improved patient comfortMerit Medi....
型号区分说明 Model differentiation
SGF1A：自粘标准款 Self‑adhesive standard
SGF1AC：自粘冷敷款 Self‑adhesive cool
SGF1V：魔术贴无胶标准款 Hook‑and‑loop standard
SGF1VC：魔术贴无胶冷敷款 Hook‑and‑loop coolMerit Medi...
4 技术参数 Technical Specifications
中文
表格
| 项目 | 参数 |
|---|---|
| 产品名称 | 囊袋压迫止血器 SAFEGUARD FOCUS™ Compression Device |
| 型号 | SGF1A、SGF1AC、SGF1V、SGF1VC |
| 组成 | 止血器本体 + 配套注射器 |
| 灭菌方式 | 环氧乙烷（EO）灭菌 |
| 使用类型 | 一次性使用，不可重复使用、不可重复灭菌 |
| 最大充气体积 | 标准款 120 mL；Cool 冷敷款 60 mL |
| 固定方式 | A：压敏医用胶；V：魔术贴绑带无胶 |
| 材质 | 球囊：TPU；管路：PVC；阀件：PC / 硅胶；绑带：尼龙；敷料无纺布；不含天然乳胶 |
| 注册人 | Merit Medical Systems, Inc.（美国麦瑞通） |
| 注册证号 | 国械注进 20242140600 |
English
| Item | Specification |
|---|---|
| Product Name | SAFEGUARD FOCUS™ Compression Device |
| Model | SGF1A, SGF1AC, SGF1V, SGF1VC |
| Components | Compression device body + supplied syringe |
| Sterilization | Ethylene‑oxide (EO) sterilization |
| Usage | Single‑use only; do not reuse or re‑sterilize |
| Max inflation volume | Standard:120 mL; Cool variant:60 mL |
| Fixation | A‑version: pressure‑sensitive medical adhesive; V‑version: adhesive‑free hook‑and‑loop strap |
| Material | Balloon:TPU; fill tube:PVC; valve:PC/silicone; strap:nylon; dressing non‑woven; natural‑rubber‑latex‑free |
| Registrant | Merit Medical Systems, Inc. |
| CFDA Registration No. | 国械注进 20242140600 |
5 使用方法 Instructions for Use
中文
确认包装完好，无菌状态，打开外包装，取出止血器与配套注射器；
清洁、干燥手术区域皮肤；确认囊袋切口已经完成缝合闭合；
将压迫气囊中心对准起搏器 / ICD 囊袋手术部位；
A（自粘型）：撕除背胶保护纸，将敷料平整粘贴于胸壁皮肤；
V（绑带型）：使用魔术贴绑带环绕胸壁固定止血器本体，气囊对准囊袋位置；
将配套注射器接头连接至充气管单向阀；缓慢向球囊注入空气，直至获得临床所需压迫效果；不可过度充气；
通过透明视窗持续观察伤口渗血、皮肤颜色、患者疼痛感受；按需微调充气量；
根据临床医嘱维持压迫时长；需要减压时，通过阀门释放球囊内空气；
完成压迫后，释放气囊压力，取下整个装置，按医疗废弃物处置；本产品一次性使用，严禁重复使用Merit Medi...。
English
Verify package integrity and sterile status; open outer pouch, take out compression device and supplied syringe.
Clean and dry skin over surgical site; confirm pocket incision is fully sutured and closed.
Center compression balloon over pacemaker / ICD surgical pocket.
Model‑A (adhesive): peel release liner, apply dressing flat onto chest‑wall skin.
Model‑V (strap): secure device onto chest wall with hook‑and‑loop straps, center balloon over pocket.
Connect supplied syringe luer tip to fill‑tube one‑way valve. Slowly inject air into balloon to achieve clinically desired compression. Avoid over‑inflation.
Continuously inspect wound oozing, skin colour and patient pain response via transparent window; fine‑tune inflation volume as needed.
Maintain compression per physician’s clinical order. For decompression, vent air from balloon through valve.
After compression therapy, fully deflate balloon and remove entire device. Dispose as bio‑medical waste. Single‑use only; do not reuseMerit Medi....
6 适应症 Indications
中文用于术后即刻对已经闭合的手术部位（包括起搏器囊袋、ICD 植入囊袋）提供外部压迫，用于减少囊袋创面渗血，辅助预防术后囊袋血肿形成。
EnglishIntended to provide external compression immediately post‑operatively over closed surgical sites, including pacemaker and ICD implantation pockets, to reduce wound oozing and assist prevention of postoperative pocket hematoma ｆormationMerit Medi....
7 禁忌症 Contraindications
中文
囊袋切口未闭合、未完成缝合，禁止使用；
自粘型号（A/AC）禁止直接粘贴于破损、糜烂、皮炎、水泡的皮肤表面；
局部存在活动性感染、皮肤化脓病灶，禁止在感染病灶上使用本装置；
对产品任一组成材质存在明确过敏的患者禁用；
不可用于开放伤口止血；不可用于血管穿刺点的动脉止血（本产品为起搏器囊袋专用）Merit Medi...。
English
Do not apply when pocket incision remains open or incompletely sutured.
Adhesive‑type models(A/AC) shall not be applied onto excoriated, eroded, dermatitic or blistered skin.
Do not place device over active local infection or purulent skin lesions.
Contraindicated for patients with known hypersensitivity to any device component material.
Not intended for open‑wound hemostasis; not for arterial puncture‑site compression; device is dedicated for pacemaker/ICD pocket application onlyMerit Medi....
8 注意事项 Cautions / Warnings
中文
本品为一次性无菌医疗器械，仅单患者单次使用；严禁重复使用、重复灭菌；重复使用会带来感染风险、性能失效。
禁止过度充气；过度压迫会造成局部皮肤缺血、压疮、组织损伤、疼痛加重。
使用期间定时观察：皮肤颜色、温度、患者主观疼痛、囊袋有无持续渗血；一旦皮肤发白、剧痛，立即减压排气。
自粘款粘贴皮肤前必须保证皮肤干燥清洁；汗液、消毒液残留会降低粘贴可靠性。
本装置仅提供机械压迫，不能替代外科缝合、外科血肿清除等临床处置；若出现进行性血肿，应遵从临床外科处理流程。
AC/VC 冷敷款：注意冷敷相关冻伤风险，严格遵守临床冷敷时间要求。
包装破损、受潮、超过有效期，禁止使用。
仅由经过培训的临床医护人员操作使用。
不含天然乳胶，但不能完全排除高分子辅料的罕见过敏反应。
废弃产品按医疗机构医疗废物管理规范处置Merit Medi...。
English
Single‑use sterile medical device for one‑patient single‑episode use only. Never reuse or re‑sterilize. Re‑use carries infection hazard and device‑function failure.
Avoid over‑inflation. Excessive compression may cause skin ischaemia, pressure injury, tissue damage and aggravated pain.
Periodic monitoring during application: skin colour, temperature, patient pain level and persistent pocket oozing. Immediately deflate balloon upon skin blanching or severe pain.
For adhesive variants: skin surface must be clean and dry before application; residual antiseptic or sweat impairs adhesion perｆormance.
This device provides mechanical compression only. It is NOT a substitute for surgical suture, surgical evacuation of hematoma or other necessary surgical interventions. Progressive hematoma requires standard surgical management.
For AC / VC cool variants: risk of cold‑induced injury; adhere strictly to clinical cooling duration protocol.
Do not use if package is damaged, wet or beyond expiry date.
Application shall be perｆormed by trained clinical medical staff only.
Device is natural‑rubber‑latex‑free; rare hypersensitivity to polymer components cannot be completely excluded.
Discard used device per hospital bio‑hazard waste regulationsMerit Medi....
9 储存条件 Storage Condition
中文
储存环境：温度 5 ℃‑40 ℃；相对湿度 30%‑75%；避免阳光直射；远离热源；
存放于干燥洁净室内，避免挤压、撞击包装；
有效期见产品外包装标签；灭菌有效期自 EO 灭菌日期起计算；
运输条件同储存条件；防止雨淋暴晒。
English
Storage ambient temperature: 5 ℃‑40 ℃; relative humidity:30%‑75%. Keep away from direct sunlight and heat sources.
Store in dry clean indoor environment; avoid package crushing and mechanical impact.
Shelf‑life is marked on outer package label; expiry calculated from EO sterilization date.
Transport under same environmental requirements as storage; protect from rain and direct sun exposure.
10 说明书核心摘要 Core IFU Summary
中文
产品：囊袋压迫止血器 SAFEGUARD FOCUS™，型号 SGF1A/SGF1AC/SGF1V/SGF1VC；Ⅱ 类进口医疗器械；一次性 EO 灭菌；分为自粘固定（A 系列）、魔术贴无胶固定（V 系列），AC/VC 附加冷敷功能；用于起搏器、ICD 闭合术后囊袋即刻机械压迫，减少渗血、降低血肿风险；气囊由配套注射器充气，透明视窗便于伤口观察；严禁重复使用；禁止过度充气；自粘型号不可贴于破损皮肤；必须由医护操作；包装破损或过期禁用；储存 5‑40℃干燥避光。临床使用以原厂随货 IFU 纸质说明书为准。
English
Product: SAFEGUARD FOCUS™ Compression Device, model SGF1A/SGF1AC/SGF1V/SGF1VC. Class II imported medical device. Single‑use EO sterilized. Two fixation families: adhesive‑backed (A‑series), adhesive‑free hook‑and‑loop (V‑series). AC/VC versions add cooling function. Indicated for immediate post‑operative mechanical compression on closed pacemaker / ICD surgical pockets to reduce oozing and hematoma risk. Balloon is inflated with supplied syringe; transparent window permits wound visualization. Single‑use only; prohibit re‑use. Avoid over‑inflation. Adhesive variants must not be applied on compromised skin. For use by trained clinical personnel only. Do not use if package damaged or expired. Store dry at 5‑40 ℃ away from sunlight. Clinical use shall follow original paper IFU supplied with each unit.
以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。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. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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