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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂商3M一次性充气式保温毯62200,54500,55000

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品牌名称:$brandModel.Title型号: 原产地:中国大陆 医疗器械注册号(批文):国械注进20212090385更新时间:2026/10/16 11:11:09

产品摘要:厂商3M一次性充气式保温毯62200,54500,55000

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厂商3M一次性充气式保温毯62200,54500,55000
桂经理19117326863微xin同号
桂经理19117326863微xin同号

产品名称 一次性充气式保温毯3M™ Bair Hugger™ Warming Blanket

管理类别 第二类

型号规格 30000, 31000, 31500, 52500, 53700, 54200, 54500, 55000, 55501, 57000, 57501, 58501, 61000, 62200, 63000, 63500

结构及组成/主要组成成分 由保温毯,软管卡组成。

适用范围/预期用途 与3M公司的675或775升温仪联合使用,为病人提供热量,预防和治疗低温症。

基础备案信息 注册证号:国械注进 20212090385 生产企业:3M Company(美国明尼苏达州) 配套主机:3M Bair Hugger 675/775 升温仪 产品类别:Ⅱ 类医疗器械,一次性使用强制空气升温毯 三款型号定位区分:

  1. 62200:多体位上身盖毯,覆盖胸肩上肢,适配仰卧 / 俯卧 / 截石 / 侧卧位手术3M Canada

  1. 54500:成人全通路身下垫毯,铺于手术台患者下方,术中全身无遮挡操作,适用于心脏、创伤、脊柱手术

  1. 55000:大龄儿童 / 小个子成人专用身下垫毯,尺寸更小,儿科手术、短小介入操作使用3M Canada

一、工作原理 Working Principle

中文

整套升温系统由升温主机 + 连接软管 + 一次性保温毯协同完成强制对流升温:

  1. 空气加热阶段(主机) 升温仪吸入环境空气,经 0.2µm 高效过滤器除菌,内部 PTC 陶瓷加热元件将空气恒温加热至 32℃/38℃/43℃三档预设温度,涡轮风机形成稳定气流输出。

  2. 热风输送阶段(连接软管) 波纹密封软管一端接主机出风口,另一端接入保温毯两端可重复密封进气口,无泄漏输送热风至毯体双层薄膜内腔。

  3. 均匀对流升温阶段(保温毯本体) 热风充入毯体内部导流通道,从毯面均匀密布的微孔持续渗出,在保温毯与患者皮肤之间形成稳定流动热空气层;通过对流热交换持续向人体传递热量,阻断体表热量散失,维持患者正常核心体温。

  4. 流体排溢设计 垫毯款(54500/55000)内置专用导流排液口,术中冲洗液、渗血可快速排出,避免液体积聚隔绝热风、影响升温效果。

English

The complete warming system consists of warming unit, connecting hose and single-use forced-air blanket to realize convective warming:

  1. Air heating process (warming unit) The blower draws ambient air, filters it through 0.2µm HEPA filter to remove contaminants. Built-in PTC ceramic heating elements heat air to 3 selectable preset temperatures (32℃/38℃/43℃). Turbine fan generates stable airflow for delivery.

  2. Hot air delivery process (connecting hose) Sealed corrugated hose connects the unit outlet to resealable hose ports at both ends of the blanket, delivering hot air into the double-layer film cavity without leakage.

  3. Uniform convective warming process (blanket body) Hot air fills internal air channels inside the blanket and continuously escapes through evenly distributed micro-perforations on patient-facing side. A stable flowing warm air layer forms between blanket and patient skin. Heat transfers to human body via forced convection to stop heat loss and maintain normothermia.

  4. Fluid drainage structure Underbody blankets (54500/55000) feature dedicated fluid outlets to rapidly drain surgical irrigation fluid and blood, preventing fluid pooling that blocks warm air and reduces warming efficiency.

二、产品功能 Product Functions

中文

  1. 围手术期低体温预防 术前、术中、术后 PACU 全程升温,阻断麻醉后血管扩张导致的体表热量流失,预防围手术期低体温。

  2. 低体温对症治疗 针对术中已出现体温下降、寒战的患者,快速提升体表温度,缓解寒战,恢复正常核心体温。

  3. 降低手术并发症风险 维持正常体温可减少术中出血、降低术后手术部位感染、心血管不良事件、术后寒战不适发生率3M Colombi...。

  4. 无遮挡术中升温(垫毯 54500/55000) 铺于患者身体下方升温,躯干、四肢完全暴露,外科医生可无遮挡开展心脏、创伤、介入、脊柱等各类手术操作。

  5. 多体位全覆盖升温(盖毯 62200) 柔性可弯折毯体,适配仰卧、俯卧、侧卧位、机器人手术、沙滩椅体位,完整覆盖上身胸肩区域,不影响头面部气道观察。

  6. 兼容影像检查 毯体无金属、全透 X 线材质,术中同步 X 光、造影、CT 介入检查无影像遮挡干扰한국쓰리엠...。

English

  1. Perioperative hypothermia prevention Continuous warming during pre-op, intra-op and PACU phase, blocks cutaneous heat loss caused by anesthesia-induced vasodilation to prevent perioperative hypothermia.

  2. Therapeutic warming for hypothermic patients Rapidly raise skin temperature for patients with intraoperative temperature drop and shivering, relieve chills and restore normal core body temperature.

  3. Reduce surgical complication risks Normothermia reduces intraoperative blood loss, lowers incidence of surgical site infection, cardiovascular adverse events and postoperative shivering discomfort3M Colombi....

  4. Unobstructed intraoperative warming (underbody blankets 54500/55000) Placed underneath patient to deliver heat, with full exposure of trunk and limbs, allowing surgeons unobstructed access for cardiac, trauma, interventional radiology and spinal surgeries.

  5. Multi-position full coverage warming (62200 upper body blanket) Flexible conformable blanket fits supine, prone, lateral, robotic and beach-chair positions, fully covering upper torso without obstructing airway observation at head end.

  6. Radiolucent for imaging compatibility Metal-free construction is fully radiolucent, allowing simultaneous X-ray, angiography and interventional CT without image artifact or obstruction한국쓰리엠....
    微信图片_20260730160949_2560_5.png

三、产品特点 Product Features

中文

通用全部型号特点

  1. 一次性独立包装,无乳胶 单人单次使用,出厂无无菌(仅升温功能耗材),不含天然橡胶乳胶,规避乳胶过敏风险3M Colombi...。

  2. 双端可密封进气口 毯子两端均预留软管接口,可灵活调整主机摆放位置,不用的接口可重新密封不漏风3M Canada。

  3. 均匀微孔导流,无局部热点 全域等距微孔设计,热风均匀渗出,不会出现局部高温烫伤区域,升温温和稳定。

  4. 轻薄柔性材质,贴合人体曲线 低厚度毯体,可弯折折叠,紧密贴合患者躯干、四肢,最大化热交换接触面积。

  5. 固定防移位设计 自带粘贴条、包裹折边,可牢固固定在手术床或患者体表,术中翻身、体位变动不易滑动移位3M Canada。

  6. 配套透明头罩(62200 标配) 上身毯附带透明头部围挡,锁住头颈部热风,同时可直观观察气管插管患者面部状态3M多媒体。

分型号专属特点

  1. 62200(多体位上身盖毯) 尺寸 198cm×61cm,低剖面轻薄结构,弯曲后热传导效率更高;适配全部上半身手术体位,肩部包裹条固定,不遮挡手臂手术操作。

  2. 54500(成人全通路身下垫毯) 成人通用大尺寸,铺台式设计,术前可提前铺在手术台上,患者转运上床即刻开始升温;多条排液导流槽,大量冲洗液快速排走,适合大创面、创伤、心脏手术。

  3. 55000(大龄儿童身下垫毯) 尺寸适配 8 岁以上儿童、矮小成人,整体尺寸缩小,贴合儿童躯干比例;材质柔软轻薄,儿科短小手术、介入造影专用,升温温和适配儿童耐受度。

English

General features for all models

  1. Single-use individual packaging, latex-free For single patient single procedure use; non-sterile warming accessory, no natural rubber latex to eliminate latex allergy risks3M Colombi....

  2. Dual resealable hose ports Ports at both blanket ends allow flexible positioning of warming unit; unused port can be resealed to prevent hot air leakage3M Canada.

  3. Uniform micro-perforations without hot spots Equidistant micro-perforations distribute hot air evenly across entire surface, eliminating localized overheating and burn risks for gentle stable warming.

  4. Thin flexible conformable material Low-profile lightweight construction bends freely to fit patient body contours, maximizing skin contact area for efficient heat exchange.

  5. Anti-slip fixation design Integrated adhesive strips and tuck flaps secure blanket firmly to operating table or patient skin, resisting sliding during patient repositioning and table tilting3M Canada.

  6. Attached clear head drape (standard for 62200) Upper body blanket includes transparent head enclosure to retain warm air around neck and head, while allowing continuous visual observation of intubated patients’ faces3M多媒体.

Model-exclusive features

  1. 62200 Multi-position Upper Body Blanket Dimensions 198cm × 61cm, ultra-low profile design delivers improved heat transfer when bent; compatible with all upper torso surgical positions, shoulder tuck strips secure blanket without obstructing arm procedures.

  2. 54500 Adult Full-Access Underbody Blanket Universal adult large size, table-placement design can be laid on surgical table pre-operatively to start warming immediately upon patient transfer; multiple fluid drainage channels rapidly evacuate large volumes of irrigation fluid, ideal for large wound, trauma and cardiac surgeries.

  3. 55000 Large Pediatric Underbody Blanket Scaled dimensions for children over 8 years old and small-stature adults, proportionally sized to fit pediatric torso; ultra-soft lightweight material with mild warming intensity matched to pediatric thermal tolerance, designed for short pediatric procedures and interventional angiography.

四、技术参数 Technical Specifications

中文

表格

参数项目62200(上身多体位盖毯)54500(成人身下垫毯)55000(大龄儿童身下垫毯)
产品型号622005450055000
产品类型上身覆盖式升温毯成人身下铺垫式升温毯儿童 / 小个子成人铺垫毯
外形尺寸198 cm × 61 cm成人全尺寸台面适配儿童缩小台面尺寸
单箱数量10 条 / 箱5 条 / 箱10 条 / 箱
进气口设计两端可重复密封软管接口两端可重复密封软管接口两端可重复密封软管接口
材质构成医用柔性复合薄膜,无金属、透 X 线,无乳胶医用柔性复合薄膜,无金属、透 X 线,无乳胶医用柔性复合薄膜,无金属、透 X 线,无乳胶
适配升温仪3M Bair Hugger 675 / 775 系列升温主机3M Bair Hugger 675 / 775 系列升温主机3M Bair Hugger 675 / 775 系列升温主机
耐受气流温度最高 43℃恒温热风最高 43℃恒温热风最高 43℃恒温热风
灭菌状态出厂非无菌,一次性使用出厂非无菌,一次性使用出厂非无菌,一次性使用
辅助配件标配透明头部围挡、颈部通风口自带液体导流排液槽、底部固定粘贴条小型导流排液槽、柔软薄型膜体

English

表格

Item62200 Multi-position Upper Blanket54500 Adult Underbody Blanket55000 Large Pediatric Underbody Blanket
Model No.622005450055000
Blanket StyleOverbody upper torso warming blanketFull-access adult underbody warming blanketPediatric / small adult underbody blanket
Overall Dimensions198 cm × 61 cmFull-size adult table compatibleScaled pediatric table size
Quantity per Case10 blankets / carton5 blankets / carton10 blankets / carton
Hose Port DesignDual resealable air inlet portsDual resealable air inlet portsDual resealable air inlet ports
Material CompositionMedical flexible composite film, mmbedl-free, radiolucent, latex-freeMedical flexible composite film, mmbedl-free, radiolucent, latex-freeMedical flexible composite film, mmbedl-free, radiolucent, latex-free
Compatible Warming Unit3M Bair Hugger 675 / 775 series blower3M Bair Hugger 675 / 775 series blower3M Bair Hugger 675 / 775 series blower
Maximum Allowable Air TemperatureConstant hot air up to 43℃Constant hot air up to 43℃Constant hot air up to 43℃
Sterility StatusNon-sterile factory packaging, single-use onlyNon-sterile factory packaging, single-use onlyNon-sterile factory packaging, single-use only
Standard AccessoriesAttached clear head drape with neck ventilation ventsBuilt-in fluid drainage channels, bottom adhesive fixation stripsMiniature fluid drainage channels, ultra-thin soft film body

微信图片_20260730160950_2561_5.png
五、使用方法 Instructions for Use

中文

通用操作步骤(全部型号通用)

  1. 术前铺放 取出保温毯,确认包装完好无破损;区分带微孔发热面与光滑背面,微孔面必须朝向患者皮肤,光滑面朝外,禁止反向使用造成烫伤风险3M多媒体。

  2. 固定定位 垫毯款(54500/55000)平铺于手术床垫面,撕下底部粘贴条保护膜,贴紧手术床固定;盖毯款(62200)覆盖患者上身,利用肩部包裹折边固定,透明头罩包裹患者头颈部。

  3. 管路连接 打开保温毯任意一端密封端口,将升温仪配套软管接头插入端口;闲置另一端端口按压密封塞封闭,防止热风外泄。

  4. 升温仪开机设置 开启 3M 升温主机,根据患者耐受度选择三档温度:32℃(低温维持)、38℃(标准术中升温)、43℃(快速复温,低体温寒战患者专用),启动风机输出热风。

  5. 术中持续监测 每 15 分钟观察患者皮肤状态、末梢循环、主诉温热感;儿童、麻醉无法沟通、末梢灌注差患者缩短监测间隔;出现皮肤发红、灼热不适立即调低温度或暂停升温3M多媒体。

  6. 术后拆除丢弃 手术结束后关闭升温仪,断开软管与保温毯接口;整张保温毯一次性使用,不可清洗、重复灭菌复用,按医疗普通耗材分类丢弃处理。

分型号特殊操作要点

  1. 62200 上身盖毯 患者俯卧、沙滩椅体位时,弯折毯体贴合背部 / 肩部,透明头罩保持开放观察气道;机器人、侧卧位手术调整两端软管接口适配主机摆放位置。

  2. 54500 成人身下垫毯 创伤、心脏大手术时,调整毯体排液槽朝向手术台废液收集口,保证术中冲洗液顺畅排出;截石位、俯卧位手术完全暴露躯干四肢,不遮挡术区操作。

  3. 55000 儿童垫毯 儿科患者优先选用 32℃/38℃低温档,禁止长期 43℃高温持续升温;体型极小儿童可对折毯体缩小覆盖面积,避免大面积热风接触娇嫩皮肤。

English

General Operation Steps (all models)

  1. Preoperative placement Unpack blanket and verify intact packaging. Distinguish perforated warming surface and smooth back surface. Perforated side must face patient skin, smooth side outward; reverse placement is prohibited to eliminate thermal burn risks3M多媒体.

  2. Secure positioning For underbody blankets (54500/55000): lay flat on surgical table, peel adhesive strip liner and adhere firmly to table surface. For 62200 overbody blanket: drape over patient upper torso, secure with shoulder tuck flaps, wrap head and neck with attached clear drape.

  3. Hose connection Open resealable port on either blanket end, insert blower hose connector fully into port; press sealing plug into unused port to block hot air leakage.

  4. Warming unit power-on setup Power on 3M Bair Hugger blower, select one of three temperature settings based on patient tolerance: 32℃ (mild maintenance), 38℃ (standard intraoperative warming), 43℃ (rapid rewarming for hypothermic shivering patients). Activate fan to deliver hot air.

  5. Intraoperative continuous monitoring Inspect patient skin condition, peripheral circulation and thermal comfort every 15 minutes. Shorten monitoring interval for pediatric patients, unconscious anesthetized patients and patients with poor peripheral perfusion. Immediately lower temperature or suspend warming if erythema, burning discomfort appear on skin3M多媒体.

  6. Post-op removal and disposal Power off warming unit after surgery, disconnect hose from blanket port. Each blanket is single-use only; cleaning, re-sterilization and reuse are forbidden. Dispose of used blanket per standard medical consumable waste protocols.

Model-specific special operation notes

  1. 62200 Upper Body Blanket For prone and beach-chair patient positions, bend blanket to conform to back and shoulder contours; keep clear head drape unobstructed for continuous airway observation. Adjust hose port (either end) to fit blower placement during robotic and lateral surgeries.

  2. 54500 Adult Underbody Blanket For trauma and major cardiac surgeries, align blanket fluid drainage channels toward table waste collection port to ensure unobstructed evacuation of surgical irrigation fluid. Provides full unobstructed trunk and limb exposure for lithotomy and prone surgical procedures.

  3. 55000 Large Pediatric Underbody Blanket Prioritize 32℃ / 38℃ low-temperature settings for pediatric patients; prolonged continuous 43℃ high-temperature warming is prohibited. Fold blanket partially to reduce coverage area for small children, preventing excessive hot air contact with delicate pediatric skin.

六、适应症 Indications

中文

本产品搭配 3M Bair Hugger 升温系统,适用于各科室围手术期体温管理,用于预防、治疗围手术期低体温,适用人群包含成人、8 岁以上大龄儿童、小个子成人:

  1. 术前:麻醉诱导前预热体表,降低麻醉后热量快速流失,避免入室后体温快速下降。

  2. 术中:普外科、骨科、心脏外科、泌尿外科、妇科、介入放射、麻醉 PACU 全部手术场景,持续维持患者正常核心体温;适配仰卧、俯卧、侧卧位、截石位、机器人、沙滩椅全部手术体位。

  3. 术后复苏室 PACU:针对术中低体温、术后寒战患者快速体表复温,缓解发抖、四肢冰凉、恶心等低温相关不适。

  4. 特殊适配场景区分

    • 62200 上身盖毯:仅需上身胸肩升温、下肢需完全暴露手术操作(上肢、乳腺、胸腔、甲状腺手术)。

    • 54500 成人垫毯:创伤、心脏、脊柱、介入造影、腹部大手术,术中需要全身躯干四肢无遮挡操作的成人患者。

    • 55000 儿童垫毯:8 岁以上儿童短小手术、儿科介入造影、矮小成人门诊手术。

English

When used with 3M Bair Hugger warming unit, this blanket is indicated for perioperative temperature management across all clinical departments, to prevent and treat perioperative hypothermia, for adult patients, children over 8 years old and small-stature adults:

  1. Preoperative phase: Pre-warm cutaneous surface prior to anesthesia induction, reduce rapid heat loss after anesthesia and prevent sharp core temperature drop upon entering OR.

  2. Intraoperative phase: Continuous normothermia maintenance for all surgical specialties including general surgery, orthopedics, cardiac surgery, urology, gynecology, interventional radiology and PACU recovery. Compatible with all surgical positions: supine, prone, lateral, lithotomy, robotic and beach-chair.

  3. Postoperative PACU recovery: Rapid cutaneous rewarming for patients with intraoperative hypothermia and postoperative shivering, relieve chills, cold extremities, nausea and other hypothermia-related discomfort.

  4. Specialized clinical scenario breakdown

    • 62200 Upper Body Blanket: Procedures requiring only upper torso warming with full lower limb surgical exposure (upper extremity, breast, thoracic, thyroid surgery).

    • 54500 Adult Underbody Blanket: Adult patients undergoing trauma, cardiac, spinal, interventional angiography and major abdominal surgeries requiring full unobstructed trunk and limb access intraoperatively.

    • 55000 Pediatric Underbody Blanket: Short surgical procedures, pediatric interventional angiography for children ≥8 years old, and outpatient procedures for small-stature adults.

      微信图片_20260730160950_2562_5.png

七、禁忌症 Contraindications

中文

  1. 绝对禁忌 主动脉阻断手术期间,禁止对下肢使用升温毯加热;阻断期间下肢肢体缺血,热风升温会加重缺血组织损伤、引发皮肤坏死烫伤3M多媒体。

  2. 相对禁忌(需严密监测,谨慎使用) ① 外周严重血管闭塞、下肢重度动脉硬化、肢体坏疽、严重末梢循环障碍患者;热风升温会加剧局部组织缺氧,造成皮肤损伤。 ② 大面积三度烧伤、皮肤破溃、严重皮炎、皮肤移植术后未愈合创面患者;热空气直接刺激破损皮肤加重疼痛、延缓创面愈合。 ③ 意识完全丧失、重度痴呆、无法感知温度、无法反馈皮肤灼热不适的患者;极易发生性皮肤烫伤,必须缩短监测间隔,每 10 分钟检查皮肤。 ④ 经皮透皮贴剂药物覆盖区域,禁止保温毯直接覆盖升温;高温会加速药物过量吸收,引发药物中毒、严重不良反应3M多媒体。

  3. 设备使用禁忌 ① 禁止单独使用升温仪软管直接对着患者吹风,必须全程配套原厂 3M 保温毯使用,单独软管无均匀控温结构,极易造成严重烫伤。 ② 禁止搭配非 3M 原厂升温主机、第三方杂牌升温毯配套使用,系统温控匹配失效,存在过热烫伤风险。 ③ 保温毯微孔光滑背面朝向患者皮肤时严禁开机升温,无均匀散热微孔,局部高温集中烫伤皮肤。

English

  1. Absolute Contraindication Do not apply warming blanket to lower extremities during aortic cross-clamping. Ischemic limbs under aortic occlusion exposed to hot air warming will suffer aggravated ischemic tissue injury, skin necrosis and thermal burns3M多媒体.

  2. Relative Contraindications (use with extreme caution and continuous close monitoring) ① Patients with severe peripheral arterial occlusion, advanced lower extremity arteriosclerosis, limb gangrene and severe peripheral perfusion defects; hot air warming exacerbates local tissue hypoxia and induces cutaneous injury. ② Patients with extensive third-degree burns, open skin lacerations, severe dermatitis and unhealed skin graft donor sites; direct hot air irritation intensifies pain and delays wound healing. ③ Patients with complete loss of consciousness, severe dementia, impaired thermal sensation and inability to report burning skin discomfort; painless thermal burns are highly likely, skin inspection required every 10 minutes. ④ Do not cover transdermal drug patches directly with warming blanket. Elevated temperature accelerates excessive systemic drug absorption, leading to drug toxicity and severe adverse reactions3M多媒体.

  3. Equipment Usage Contraindications ① Never blow hot air directly onto patient skin using only the blower hose without matching original 3M warming blanket. Bare hose lacks uniform heat dispersion structure and causes severe concentrated thermal burns. ② Do not pair this blanket with non-3M original warming blowers or third-party generic warming blankets. Mismatched temperature control system creates overheating and burn hazards. ③ Do not activate warming unit if the smooth non-perforated back side of blanket faces patient skin. Lack of evenly distributed vent holes creates localized concentrated high temperature leading to skin burns.

八、注意事项 Precautions & Warnings

中文

  1. 一次性使用强制要求 每条保温毯单一名患者单次手术使用,严禁清洗、浸泡、高温灭菌后重复复用;反复使用会造成微孔堵塞、局部过热,同时存在交叉感染风险。

  2. 皮肤监测核心要求 麻醉镇静、儿童、老年人、糖尿病周围神经病变、感觉迟钝患者为烫伤高风险人群,升温全程缩短皮肤检查间隔,一旦出现皮肤发红、发烫立即停止升温。

  3. 软管安全规范 禁止患者身体直接压在升温连接软管上;软管不可紧贴皮肤、缠绕肢体,软管表面持续热风会造成长条带状皮肤烫伤。

  4. 材质安全提示 产品无天然乳胶,但手术室存在乳胶过敏患者时,操作时避免手套、器械摩擦毯体产生粉尘接触过敏。

  5. 手术无菌区域隔离 保温毯为非无菌耗材,毯体不可铺放、覆盖手术无菌切口区域,仅可覆盖患者非术区皮肤,避免污染无菌创面。

  6. 火灾热源防护 毯体面料为普通可燃织物,术中高频电刀、激光、高温器械靠近毯体时需做好遮挡隔离,防止火花引燃毯体。

  7. 升温仪故障应急 升温主机出现超温报警、异常高温停机时,立即断开软管与保温毯接口,停止热风输送,更换完好设备后再继续升温,故障设备禁止继续使用。

  8. 儿科专项防护 婴幼儿、儿童皮肤薄、热耐受度低,优先低温档位,禁止长时间高温持续升温;儿童升温过程全程不可无人看管。

English

  1. Mandatory single-use regulation Each warming blanket is for one single patient, one single surgical procedure only. Cleaning, soaking, autoclave sterilization and reuse are strictly prohibited. Reused blankets develop clogged perforations causing localized overheating, alongside cross-contamination infection risks.

  2. Critical skin monitoring requirement High burn-risk populations include sedated anesthetized patients, children, elderly patients, diabetic peripheral neuropathy and impaired thermal sensation patients. Shorten skin inspection intervals throughout warming; immediately discontinue warming if skin erythema or hotness appears.

  3. Blower hose safety rules Do not allow patient body weight to rest directly on the connecting blower hose. Hose must not lie tight against skin or wrap around limbs; constant hot air along hose surface creates linear strip thermal burns.

  4. Material safety reminder Product contains no natural rubber latex. For latex-sensitive patients in OR, avoid friction between latex surgical gloves/instruments and blanket surface to prevent allergen dust exposure.

  5. Sterile surgical field isolation rule This blanket is non-sterile consumable. Blanket must not be laid over or cover sterile surgical incision sites; only apply to non-surgical patient skin to avoid sterile wound contamination.

  6. Fire & high-temperature source protection Blanket fabric is ordinary combustible material. Use physical barrier shielding when electrocautery, laser and hot surgical instruments operate near blanket to prevent ignition from sparks.

  7. Warming unit malfunction emergency protocol If blower triggers over-temperature alarm or shuts down due to abnormal high temperature, immediately disconnect hose from blanket port to cut hot air supply. Replace with fully functional equipment before resuming warming; malfunctioning blowers cannot continue operation.

  8. Special pediatric safety precautions Infants and children have thin skin and low thermal tolerance; always start with low-temperature settings, prolonged continuous high-temperature warming is forbidden. Pediatric patients must never be left unattended during warming therapy.

九、存储条件 Storage Conditions

中文

  1. 存储温度 未拆封成品存储环境温度:10℃ ~ 30℃;禁止存放于阳光直射窗台、暖气设备旁、手术室高温设备储物间、冷冻低温环境。

  2. 环境湿度 仓储相对湿度 30% ~ 75%,存储区域无冷凝水、无积水;远离消毒池、清洗间、蒸汽灭菌室等高湿潮湿区域,防止外包装受潮破损、毯体薄膜粘连。

  3. 仓储环境洁净要求 存放仓库、耗材储物间需干燥通风、无尘、无油烟、无化学腐蚀性试剂(含酒精、含氯消毒液、酸碱消毒剂);不可与消毒耗材、强酸强碱药剂同柜混放,化学蒸汽会腐蚀毯体薄膜、破坏微孔结构。

  4. 堆叠摆放规范 外包装纸箱直立竖直存放,纸箱堆叠高度不超过 6 层;禁止倒置、侧放、重物重压堆叠,受压会造成内部保温毯弯折变形、导流微孔堵塞。

  5. 保质期管控 未开封保温毯严格按照外包装印刷有效期存放,超过有效期禁止拆封用于临床手术;开封后必须立即使用,不可拆封裸露长时间存放。

  6. 运输临时存储 转运过程避免暴力抛掷、挤压、重物碾压;运输外包装保持完整密封,做好防雨防潮防护,防止雨水浸湿包装损坏毯体。

English

  1. Storage temperature Unopened finished blankets shall be stored at ambient temperature between 10℃ ~ 30℃. Storage under direct sunlight, beside heating radiators, high-temperature OR equipment storage rooms and freezing environments is prohibited.

  2. Ambient humidity requirement Storage relative humidity range: 30% ~ 75%, no condensation or standing water in storage area. Keep far away from high-humidity zones including disinfection sinks, washing rooms and steam sterilization suites, to prevent outer packaging moisture damage and blanket film adhesion.

  3. Storage area cleanliness requirement Warehouse and consumable storage cabinets must be dry, ventilated, dust-free, free of oil fumes and corrosive chemical agents (alcohol, chlorine-based disinfectants, acid/alkali sanitizers). Do not store alongside disinfection supplies or strong acid/alkaline chemicals in the same cabinet; chemical vapors degrade blanket film and permanently damage vent perforation structure.

  4. Stacking placement regulations Store outer cartons upright vertically, maximum stacking height limited to 6 carton layers. Inverted, sideways storage and heavy load compression stacking are forbidden; compressive force causes permanent blanket bending deformation and irreversible clogging of vent micro-perforations.

  5. Shelf life control Unopened blankets must be stored strictly within the expiry date printed on outer packaging. Expired blankets cannot be unpacked for clinical surgical use. Once packaging is opened, blanket must be used immediately; prolonged open exposed storage is not allowed.

  6. Temporary storage during transportation Avoid violent dropping, squeezing and heavy object crushing during transit. Keep outer shipping packaging fully sealed with rain and moisture protection to prevent blanket damage from water infiltration.

    微信图片_20260730160951_2563_5.png

十、说明书核心信息 Manual Core Information

中文

  1. 产品注册备案信息 通用名称:一次性充气式升温毯 商品名:3M Bair Hugger 强制空气保温毯 注册证编号:国械注进 20212090385 境外生产企业:3M Company 生产地址:St. Paul, Minnesota, USA 国内代理人:3M 中国有限公司 产品分类:Ⅱ 类医疗器械,09-03 体温管理器具 出厂状态:独立密封包装,非无菌,环氧乙烷灭菌外包装(仅外包装灭菌,毯体本身无无菌等级) 型号清单:62200、54500、55000

  2. 结构组成 保温毯由医用柔性复合薄膜(无乳胶、透 X 线)、全域均匀微孔发热层、两端可重复密封进气软管端口、固定粘贴条 / 包裹折边、62200 标配透明头部围挡构成;不含金属组件、无内置电气元件,仅作为热风流通载体,配套单独升温仪主机、连接软管使用。

  3. 预期用途 配合 3M Bair Hugger 系列 675/775 二氧化碳升温仪,用于成人及 8 岁以上大龄儿童围手术期体温管理,预防和治疗围手术期低体温,维持患者术中正常核心体温,降低低体温相关手术并发症。三款型号根据手术体位、术区暴露需求区分适用场景。

  4. 核心安全声明 ① 与原厂 3M Bair Hugger 675/775 升温仪配套使用,禁止适配其他品牌、其他系列升温设备; ② 严格一次性单人单次使用,禁止清洗、灭菌、重复使用,复用存在烫伤、交叉感染双重风险; ③ 升温毯微孔发热面必须贴合患者皮肤,反向使用会造成局部高温烫伤; ④ 主动脉阻断手术下肢禁用升温加热;外周循环障碍、皮肤破损、感觉迟钝患者必须缩短皮肤监测间隔; ⑤ 不可覆盖透皮药物贴剂、无菌手术切口区域,避免药物过量吸收、无菌创面污染; ⑥ 升温软管不可压在患者身下、紧贴皮肤缠绕肢体,防止带状皮肤烫伤; ⑦ 毯体为可燃材质,术中远离电刀、激光、高温火花热源,做好防火隔离; ⑧ 仅由经过围手术期体温管理专项培训的医护人员操作使用,儿童、意识障碍患者升温全程不可无人看管。

  5. 报废与废弃物处置规范 使用完毕的保温毯无生物危险分类(无直接侵入患者无菌创面),属于普通一次性医用耗材;使用后密封装入医疗耗材垃圾袋,按照医院普通医用垃圾统一无害化处置,禁止随意丢弃、回收翻新复用。

  6. 常见故障简易排查 ① 升温仪热风输出但毯体无发热:检查两端软管端口密封塞是否全部闭合,软管接头是否完全插紧;端口漏气会造成热风全部外泄,毯体内无充足热风流通。 ② 升温仪频繁超温报警:确认使用原厂匹配保温毯,未混用第三方杂牌毯;检查毯体微孔是否被血迹、组织碎屑大面积堵塞,微孔堵塞热风无法散出,内部积热触发主机高温报警。 ③ 毯体固定易滑动移位:撕除底部粘贴条保护膜,完全贴合手术床台面;调整包裹折边缠绕患者躯干,增加贴合摩擦力。 ④ 升温过程患者皮肤灼热发红:立即调低升温档位或直接关闭升温仪;检查毯体是否反向放置(光滑背面贴皮肤),更换正确贴合方式,缩短后续皮肤检查频次。

English

  1. Product Registration Core Information Generic Name: Single-use Forced-Air Warming Blanket Trade Name: 3M Bair Hugger Warming Blanket NMPA Registration No.: 国械注进 20212090385 Overseas Manufacturer: 3M Company Manufacturing Address: St. Paul, Minnesota, United States Domestic China Agent: 3M China Co., Ltd. Device Classification: Class Ⅱ Medical Device, Category 09-03 Body Temperature Management Equipment Factory Packaging Condition: Individual sealed packaging, non-sterile blanket body; outer carton sterilized via EO ethylene oxide (only packaging is sterilized, blanket itself carries no sterile grade) Available Models: 62200, 54500, 55000

  2. Structural Composition Blanket construction consists of medical flexible composite film (latex-free, radiolucent), evenly distributed micro-perforated warming layer, dual resealable hose inlet ports, adhesive fixation strips and tuck flaps; model 62200 includes integrated transparent head drape as standard accessory. Contains zero mmbedl components and no built-in electrical parts, functions solely as a carrier for circulating hot air, requires separate original Bair Hugger warming blower and connecting hose for complete system operation.

  3. Intended Use Used in conjunction with 3M Bair Hugger 675 / 775 series warming blowers for perioperative temperature management of adult patients and children over 8 years old. Indicated for prevention and treatment of perioperative hypothermia, maintenance of stable core body temperature during surgery, and reduction of hypothermia-associated surgical complications. The three distinct models are differentiated for clinical use cases based on surgical patient positioning and surgical field exposure requirements.

  4. Core Safety Statements ① For exclusive use with original 3M Bair Hugger 675 / 775 warming blowers only; pairing with non-3M brand or incompatible series warming equipment is strictly prohibited. ② Mandatory single-patient single-procedure single-use rule; cleaning, autoclave sterilization and reuse are forbidden, reused blankets carry dual hazards of thermal burns and cross-contamination infection. ③ The perforated warming surface of the blanket must be placed directly against patient skin; reversed placement with smooth non-perforated side touching skin causes localized concentrated high-temperature burns. ④ Warming the lower extremities during aortic cross-clamping is an absolute contraindication. Patients with peripheral circulatory impairment, open skin lesions and impaired thermal sensation require significantly shortened skin inspection intervals throughout warming therapy. ⑤ Do not cover transdermal medication patches or sterile surgical incision sites with the blanket, to avoid excessive systemic drug absorption and contamination of sterile surgical wounds. ⑥ The blower connecting hose must not be compressed under patient body weight or wrapped tightly around limbs against skin, to prevent linear strip thermal burns along hose contact areas. ⑦ Blanket fabric is combustible material; maintain physical fire barrier shielding during surgery when electrocautery, laser and high-temperature spark sources are in use. ⑧ Operation restricted to medical staff with specialized training in perioperative temperature management. Pediatric patients and patients with impaired consciousness must never be left unattended during warming treatment.

  5. Scrap and Waste Disposal Guidelines Used warming blankets are classified as general single-use medical consumables with no high biological hazard risk (no direct contact with sterile surgical incisions). After use, seal each blanket inside medical waste plastic bags for centralized harmless disposal per hospital general medical waste management protocols. Random discard, collection, refurbishment and reuse of discarded blankets are prohibited.

  6. Troubleshooting for Common System Malfunctions ① Blower delivers hot air but blanket remains cold: Verify all unused port sealing plugs are fully inserted, and blower hose connector is fully locked into blanket port. Air leakage from unsealed ports vents all hot air externally with insufficient airflow circulating inside blanket cavity. ② Blower repeatedly triggers over-temperature alarm: Confirm original matching 3M blanket is in use, no third-party generic blanket is connected. Inspect blanket perforations for large-area clogging from blood or tissue debris; blocked vents trap hot air inside blanket cavity and activate the blower overheat safety alarm. ③ Blanket slips and shifts easily during surgery: Peel off protective liner from bottom adhesive strips and press firmly against surgical table surface; wrap integrated tuck flaps around patient torso to increase friction and secure blanket positioning. ④ Patient reports burning erythema on skin during warming: Immediately lower blower temperature setting or power off warming unit entirely. Inspect blanket orientation for reversed placement (smooth non-perforated side against skin), reposition blanket with perforated side facing patient, and increase frequency of subsequent skin visual inspections.
    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:厂商3M一次性充气式保温毯622005450055000,3M一次性充气式保温毯,保温毯62200

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