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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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厂家供应3M患者升温系统775,675

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厂家供应3M患者升温系统775,675
桂经理19117326863微xin同号
桂经理19117326863微xin同号

产品名称 患者升温系统Bair Hugger Patient Warming System

管理类别 第二类

型号规格 775,675

结构及组成/主要组成成分 775由主机、支架、软管、充气式保温毯(具体型号见附页)组成。 675 由主机、软管、充气式保温毯(具体型号见附页)组成。

适用范围/预期用途 在医疗机构使用,为病人提供温暖,预防和治疗低温症。

产品全称:3M 充气式强制空气患者升温仪(Model 775 款 / Model 675 紧凑型基础款) 厂商:3M 公司(美国明尼苏达) 系统组成:升温主机、柔性送风软管、一次性无菌升温毯 / 升温袍、空气过滤芯

一、工作原理 Working Principle

中文

本设备为强制对流热风升温系统,依靠鼓风、加热、过滤、分布式散热完成患者体表体温管理:

  1. 空气循环过滤:主机底部风机吸入环境空气,经 MERV14 级高效过滤芯滤除尘埃、微生物,避免污染患者创面;

  2. 恒温加热模块:过滤后的洁净空气流经内置电热丝加热组件,主机内置多路温度传感器实时采集出风口气流温度,闭环控制加热功率,稳定输出设定温度热风;

  3. 热风输送扩散:恒温热风通过专用柔性送风软管输送至一次性充气升温毯;毯体布满均匀微孔,热风缓慢、柔和弥散覆盖患者躯干、四肢体表;

  4. 体温调节机制:热风与人体皮肤形成持续热对流,补充机体热量、减少皮肤辐射 / 传导散热,提升外周体表温度,维持核心体温稳定,预防、治疗围手术期低体温症;

  5. 双重温控安全逻辑:出风口实时测温 + 整机超温熔断双重防护,当气流温度超过 56℃安全阈值,设备自动切断加热并声光报警,杜绝局部高温烫伤3M多媒体。

English

This device is a forced convection warm air patient warming system, which completes patient surface temperature management through air blowing, heating, filtration and distributed heat dissipation:

  1. Air circulation & filtration: The fan at the bottom of the main unit draws in ambient air, which passes through a MERV14 high-efficiency filter to remove dust and microorganisms and prevent contamination of the patient’s wound.

  2. Constant-temperature heating module: Filtered clean air flows through the built-in electric heating wire assembly. Multiple built-in temperature sensors collect air outlet temperature in real time, and closed-loop control adjusts heating power to stably output warm air at the set temperature.

  3. Warm air delivery & diffusion: Constant-temperature warm air is delivered to the disposable inflatable warming blanket through a dedicated flexible air hose. The blanket is covered with uniform micropores, allowing warm air to diffuse gently and evenly over the patient’s trunk and limbs.

  4. Thermoregulation mechanism: Continuous thermal convection forms between warm air and human skin to supplement body heat, reduce heat loss via skin radiation and conduction, raise peripheral surface temperature, stabilize core body temperature, and prevent and treat perioperative hypothermia.

  5. Dual temperature safety logic: Dual protection of real-time air outlet temperature measurement and over-temperature cut-off. When airflow temperature exceeds the 56°C safety threshold, the unit automatically cuts off heating and triggers audible & visual alarms to avoid high-temperature thermal injury.

二、产品功能 Product Functions

中文

通用功能(775、675 共有)

  1. 多档恒温输出:低 32℃、中 38℃、高 43℃三档固定温度,另设环境常温档(不加热,仅送风);

  2. 双档风速调节:高风量快速升温、低风量温和保温,适配成人、儿童、新生儿;

  3. 声光多重安全报警:超温报警、传感器故障报警、滤芯堵塞提示;

  4. 兼容全系一次性耗材:适配成人全身毯、半身毯、儿科专用毯、升温保暖袍;

  5. 灵活安装固定:可平放台面、壁挂、输液杆夹持、手术床导轨固定;

  6. 整机开机自检:通电自动完成电路、传感器、风机故障诊断,异常代码屏幕显示。

775 机型独有功能

  1. 累计工作时长计时器:屏幕实时记录设备总运行小时,便于滤芯定期更换维护;

  2. 独立故障诊断模式:维修专用后台,可校准温度传感器、读取设备运行日志;

  3. 大尺寸高清数字显示屏:实时显示出风口温度、工作模式、风速档位;

  4. 更强送风流量:最大气流 40L/s,大面积患者快速升温。

675 紧凑型机型独有功能

  1. 轻量化迷你机身,自带软管收纳槽,节省手术室空间;

  2. 简化操作面板,基础温控、风速按键,操作极简;

  3. 壁挂轻量化支架配套,适合门诊、PACU 复苏室小型点位使用3M Canada。

English

General Functions (Shared by Model 775 & 675)

  1. Multi-level constant temperature output: 3 fixed temperature settings: Low 32°C, Medium 38°C, High 43°C; plus Ambient mode (air supply without heating).

  2. 2-speed airflow adjustment: High airflow for rapid warming, Low airflow for gentle thermal maintenance, suitable for adults, children and neonates.

  3. Multi-channel audible & visual safety alarms: Over-temperature alarm, sensor failure alarm, filter clog reminder.

  4. Full compatibility with all disposable consumables: Compatible with full-body adult blankets, half-body blankets, pediatric blankets and warming gowns.

  5. Flexible mounting options: Flat surface placement, wall mounting, IV pole clamping, surgical rail mounting.

  6. Automatic power-on self-test: Automatically completes circuit, sensor and fan fault diagnosis after power-on; fault codes displayed on screen for abnormalities.

Exclusive Functions of High-end Model 775

  1. Cumulative runtime hour meter: Screen displays total operating hours for regular filter replacement and maintenance.

  2. Independent diagnostic service mode: Maintenance background for temperature sensor calibration and equipment operation log reading.

  3. Large high-definition digital display: Real-time display of precise air outlet temperature, working mode and airflow speed.

  4. Higher maximum airflow: Max airflow up to 40L/s for rapid warming of large-body-surface patients.

Exclusive Functions of Compact Model 675

  1. Ultra-light mini chassis with built-in hose storage slot to save OR space.

  2. Simplified operation panel with basic temperature and airflow buttons for intuitive operation.

  3. Matching lightweight wall mount bracket, ideal for small clinical areas such as outpatient departments and PACU recovery rooms.

    微信图片_20260730151950_2545_5.png

三、产品特点 Product Features

中文

共通特点(775&675)

  1. 医用级洁净送风:MERV14 高效过滤,拦截细菌、粉尘,术中使用不污染手术无菌区;

  2. 闭环控温:气流温度精度 ±1.5℃,温度稳定无大幅波动,避免忽冷忽热;

  3. 低噪静音风机:手术室低噪音运行,不干扰监护仪、医护沟通;

  4. 一次性无菌升温耗材:单人单次使用,杜绝交叉感染风险;毯体微孔均匀散热,无局部热点烫伤隐患;

  5. 全球宽电压适配:100–240V 宽电压,适配国内外医疗机构供电环境;

  6. 多层安全防护:超温断电、过热熔断、传感器脱落保护,三重安全屏障;

  7. 多临床场景适配:术前预保温、术中持续保温、术后复苏、ICU 重症、急诊抢救、儿科低温干预全场景覆盖。

Model 775 优势特点

  1. 大容量风机,升温效率更高,适用于长时间大手术、肥胖患者、低温重症;

  2. 带运行计时、故障诊断,便于医院设备科标准化维保管理;

  3. 机身承重更强,可配套四轮移动推车,适合手术室多床位轮换使用。

Model 675 优势特点

  1. 体积小巧、重量轻,占地面积小,空间紧凑的门诊、日间手术室;

  2. 价格经济,基础保温需求性价比高;

  3. 自带软管收纳,管线整洁不易缠绕。

English

Shared Features (Model 775 & 675)

  1. Medical-grade clean air supply: MERV14 high-efficiency filter traps bacteria and dust to avoid contamination of sterile surgical fields during operation.

  2. Precise closed-loop temperature control: Airflow temperature accuracy ±1.5°C with stable output without sharp fluctuations to prevent sudden hot/cold stimulation.

  3. Low-noise silent fan: Low decibel operation in operating rooms without interfering with patient monitors or clinical communication.

  4. Disposable sterile warming consumables: Single-patient single-use design eliminates cross-contamination risks. Uniform micropores on blankets deliver even heat distribution without localized hot spots that cause burns.

  5. Global wide voltage compatibility: 100–240V wide input voltage adapts to power supply environments of domestic and overseas medical institutions.

  6. Multi-layer safety protection: Triple safety barriers including over-temperature power cut, thermal fuse cut-off and sensor disconnection protection.

  7. Full clinical scene coverage: Suitable for pre-operative pre-warming, intra-operative continuous thermal support, post-anesthesia recovery, ICU critical care, emergency resuscitation and pediatric hypothermia intervention.

Advantages of Model 775

  1. High-capacity fan delivers superior warming efficiency for long-duration major surgeries, obese patients and severe hypothermia cases.

  2. Built-in runtime timer and diagnostic mode support standardized maintenance management by hospital biomedical engineering departments.

  3. Robust chassis compatible with 4-wheel rolling carts for rotational use across multiple OR beds.

Advantages of Model 675

  1. Compact, lightweight design with minimal footprint, ideal for space-limited outpatient clinics and day-surgery rooms.

  2. Cost-effective with competitive pricing for basic routine thermal management demands.

  3. Integrated hose storage compartment keeps tubing tidy and prevents tangling.

四、技术参数 Technical Specifications

中文

表格

参数项目Model 775Model 675
产品型号Bair Hugger 775Bair Hugger 675
温控档位32℃/38℃/43℃ + 常温档32℃/38℃/43℃ + 常温档
温度精度±1.5℃±1.5℃
最大安全超温阈值56℃,自动断电报警56℃,自动断电报警
风速档位高 / 低两档,最大 40L/s高 / 低两档,标准流量
过滤等级MERV14 高效空气滤芯MERV14 高效空气滤芯
电源输入100–240VAC 50/60Hz100–240VAC 50/60Hz
整机尺寸(高 × 宽 × 深)33cm × 35cm × 33cm紧凑型,小于 775 体积
整机重量7.3kg<6kg
显示屏幕数字高清显示屏,带计时简易数字显示屏,无计时
安装方式台面、壁挂、输液杆、移动推车台面、壁挂、输液杆
配套耗材全系列 3M 一次性升温毯 / 袍全系列 3M 一次性升温毯 / 袍
滤芯更换周期每 500 运行小时或 12 个月每 500 运行小时或 12 个月
医用安全标准IEC 60601-1、UL60601 医用电气设备标准IEC 60601-1、UL60601 医用电气设备标准

English

表格

Specification ItemModel 775Model 675
Model NameBair Hugger 775Bair Hugger 675
Temperature Presets32°C / 38°C / 43°C + Ambient Mode32°C / 38°C / 43°C + Ambient Mode
Temperature Accuracy±1.5°C±1.5°C
Max Over-Temp Safety Cutoff56°C, auto power-off + alarm56°C, auto power-off + alarm
Airflow SpeedsHigh / Low, Max 40L/sHigh / Low, Standard Flow Rate
Air Filter RatingMERV14 High-Efficiency FilterMERV14 High-Efficiency Filter
Power Input100–240VAC 50/60Hz100–240VAC 50/60Hz
Unit Dimensions (H×W×D)33cm × 35cm × 33cmCompact size, smaller than Model 775
Unit Weight7.3kg<6kg
Display PanelDigital HD display with runtime hour meterSimplified digital display, no hour meter
Mounting OptionsFlat surface, wall mount, IV pole, rolling cartFlat surface, wall mount, IV pole
Compatible ConsumablesFull line of 3M disposable warming blankets & gownsFull line of 3M disposable warming blankets & gowns
Filter Replacement CycleEvery 500 operating hours or 12 monthsEvery 500 operating hours or 12 months
Medical Safety StandardsComplies with IEC 60601-1, UL60601 medical electrical equipment standardsComplies with IEC 60601-1, UL60601 medical electrical equipment standards


微信图片_20260730151951_2546_5.png

五、使用方法 Instructions for Use

中文

1. 使用前准备

  1. 设备放置:主机底部进气口不可堵塞,禁止直接落地,使用支架 / 推车抬高放置;

  2. 耗材安装:将送风软管一端接入主机出风口,另一端连接一次性升温毯充气接口;确认毯体无破损、微孔通畅;仅使用 3M 原厂一次性升温毯,禁止搭配第三方毯体;

  3. 患者准备:将升温毯带微孔一面紧贴患者皮肤,无孔面朝外;毯体平整覆盖躯干 / 四肢,避免软管直接接触皮肤;

  4. 通电自检:接通电源,设备自动开机自检,无故障代码即可进入待机模式。

2. 参数设置与升温操作

  1. 风速选择:大面积全身保温选风速;儿童、新生儿、局部保温选用低档风速;

  2. 温度档位选择:

    • 术前预保温、低体温重症:43℃高温档;

    • 术中常规维持体温:38℃中温档;

    • 术后温和保温、皮肤敏感患者:32℃低温档;

    • 仅送风不加热:常温档;

  3. 启动升温:按下对应温度按键,风机与加热模块同步启动;屏幕实时显示出风口温度;

  4. 术中持续监护:全程观察患者皮肤颜色、意识、外周循环;每 15 分钟检查毯体贴合状态,防止移位造成软管直接接触皮肤。

3. 治疗结束收尾

  1. 停机操作:先切换至常温档送风 5 分钟,散去毯体内余热;再按下待机键关闭加热与风机;

  2. 耗材处置:一次性升温毯单人单次使用,使用后按医用感染性废物密封丢弃,严禁重复使用;

  3. 设备清洁:断开电源,使用医院合规医用消毒湿巾擦拭主机外壳、软管外表面;进气滤网拆下冲洗晾干后装回;

  4. 收纳存放:软管规整收纳于设备卡槽,主机放置干燥通风区域存放。

English

1. Pre-treatment Preparation

  1. Unit placement: Do not block the air intake vent at the bottom of the main unit. Never place the unit directly on the floor; elevate with dedicated brackets or rolling carts.

  2. Consumable installation: Connect one end of the air hose to the unit’s air outlet port, and attach the other end to the inflation port of the disposable warming blanket. Confirm the blanket is intact with unobstructed micropores. Only use genuine 3M disposable warming blankets; third-party blankets are prohibited.

  3. Patient preparation: Place the perforated side of the warming blanket directly against the patient’s skin, with the non-perforated side facing outward. Lay the blanket flat over the patient’s trunk and limbs; avoid direct skin contact between the air hose and patient.

  4. Power-on self-test: Connect mains power; the unit automatically initiates self-test. Proceed to standby mode if no fault codes appear.

2. Parameter Setup & Warming Operation

  1. Airflow selection: Select High airflow for full-body large-area warming; select Low airflow for pediatric, neonatal or localized thermal support.

  2. Temperature preset selection:

    • Pre-operative pre-warming & severe hypothermia: High 43°C

    • Routine intra-operative core temperature maintenance: Medium 38°C

    • Mild post-op thermal support & patients with sensitive skin: Low 32°C

    • Air circulation without heating: Ambient Mode

  3. Activate warming therapy: Press the corresponding temperature button; the fan and heating module activate simultaneously. The display shows real-time air outlet temperature.

  4. Continuous intra-operative monitoring: Constantly observe the patient’s skin tone, consciousness and peripheral circulation. Inspect blanket fit every 15 minutes to prevent shifting that causes direct hose-to-skin contact.

3. Post-procedure Shutdown & Cleanup

  1. Shutdown procedure: Switch to Ambient Mode and circulate room-temperature air for 5 minutes to dissipate residual heat inside the blanket. Press Standby to shut down the fan and heating elements.

  2. Consumable disposal: Disposable warming blankets are single-use per patient. Seal and discard as infectious medical waste after use; reuse is strictly forbidden.

  3. Equipment disinfection: Disconnect power supply. Wipe the unit housing and outer hose surface with hospital-approved medical disinfectant wipes. Remove the intake filter, rinse thoroughly with clean water, air-dry fully and reinstall.

  4. Storage: Neatly coil the air hose into the unit’s storage slot, and store the main unit in a dry, well-ventilated area.

六、适应症 Indications

中文

本升温系统用于医疗机构围手术期、重症监护、急诊场景,预防和治疗成人、儿童、新生儿低体温症:

  1. 术前预保温:手术前 30 分钟升温,提升患者基础体温,预防麻醉诱导后核心体温快速下降;

  2. 术中持续保温:全身麻醉、椎管内麻醉手术,弥补术中皮肤散热,维持核心体温 36℃以上;

  3. 术后复苏保温:PACU 麻醉苏醒阶段,改善寒战、四肢冰凉,缓解术后低体温并发症;

  4. 重症低温干预:ICU 休克、创伤大出血、烧伤患者,纠正外周循环低体温;

  5. 急诊抢救保温:失温、外伤失血、休克急诊患者,快速补充机体热量;

  6. 儿科专用保温:婴幼儿、新生儿手术,婴幼儿皮肤散热快,需持续温和控温升温;

  7. 改善低体温相关并发症:降低手术切口感染风险、减少术中出血、减轻麻醉后寒战、缩短术后苏醒时间3M多媒体。

English

This warming system is used in perioperative, critical care and emergency clinical settings to prevent and treat hypothermia in adults, children and neonates:

  1. Pre-operative pre-warming: Initiate warming 30 minutes prior to surgery to raise baseline body temperature and prevent rapid core temperature drop after anesthesia induction.

  2. Intra-operative continuous thermal support: Compensate for cutaneous heat loss during general and neuraxial anesthesia to maintain core body temperature above 36°C.

  3. Post-anesthesia recovery warming: Relieve shivering and cold extremities during PACU emergence and mitigate complications caused by post-op hypothermia.

  4. Critical care hypothermia intervention: Correct peripheral hypothermia in ICU patients with shock, major traumatic hemorrhage and burn injuries.

  5. Emergency resuscitation thermal support: Rapidly replenish body heat for emergency patients with accidental hypothermia, traumatic blood loss and circulatory shock.

  6. Pediatric dedicated warming: Continuous gentle temperature control for infant and neonatal surgery, as pediatric skin exhibits accelerated heat loss.

  7. Reduce hypothermia-related complications: Lower surgical site infection risk, decrease intra-operative blood loss, alleviate post-anesthetic shivering and shorten post-operative emergence time.


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七、禁忌症 Contraindications

中文

绝对禁忌症(严禁升温,禁止使用设备)

  1. 主动脉阻断手术期间,禁止对患者下肢实施热风升温;肢体缺血状态下加热会造成下肢不可逆皮肤、肌肉热损伤;

  2. 升温毯微孔加热面严禁直接接触裸露创面、三度烧伤、皮肤坏死区域;持续热风加热缺血破损组织会加重组织坏死、扩大创面;

  3. 不可用于存在严重外周动脉闭塞、肢体完全无血流灌注的肢体;加热缺血肢体引发热灼伤、组织坏死。

相对禁忌症(医师充分评估获益>风险,全程专人严密监护下谨慎使用)

  1. 严重外周神经病变、糖尿病周围神经病变、脊髓损伤、皮肤感觉缺失患者;患者无法感知灼热痛感,极易发生性深度烫伤;

  2. 大面积严重创伤、挤压伤、肢体严重水肿患者;局部组织循环差,热风易蓄积热量造成烫伤;

  3. 新生儿极低体重早产儿、皮肤极度娇嫩患儿;必须选用低档风速、低温档位,缩短单次升温时长,持续监测皮肤状态;

  4. 皮肤急性皮炎、过敏性皮疹、大面积湿疹患者;持续热风刺激会加重皮肤炎症、瘙痒红肿。

English

Absolute Contraindications (Warming therapy strictly prohibited)

  1. Do not apply forced-air warming to the patient’s lower extremities during aortic cross-clamping. Heating ischemic limbs causes irreversible thermal injury to lower-extremity skin and muscle tissue.

  2. The perforated heating surface of the warming blanket must never make direct contact with exposed open wounds, third-degree burns or necrotic skin areas. Continuous warm air heating of ischemic damaged tissue worsens necrosis and expands wound size.

  3. Do not apply warming to limbs with severe peripheral arterial occlusion and complete absence of limb perfusion. Heating ischemic limbs results in thermal burns and tissue necrosis.

Relative Contraindications (Use cautiously only after full physician risk-benefit assessment with continuous dedicated staff monitoring)

  1. Patients with severe peripheral neuropathy, diabetic peripheral neuropathy, spinal cord injury or complete loss of cutaneous sensation. These patients cannot perceive burning pain and are at high risk of painless deep thermal burns.

  2. Patients with extensive severe trauma, crush injuries or severely edematous limbs. Poor local tissue circulation traps heat from warm air and causes thermal burns.

  3. Extremely low-birth-weight preterm neonates and infants with ultra-delicate skin. Only Low airflow and Low temperature settings may be used; single warming sessions must be shortened with continuous skin condition monitoring.

  4. Patients with acute dermatitis, allergic rash or extensive eczema. Continuous warm air irritation exacerbates skin inflammation, pruritus and erythema.

八、注意事项 Precautions & Warnings

中文

  1. 耗材强制原厂配套:仅可使用 3M 原厂一次性升温毯、升温袍;第三方非标毯体透气性、散热不均,极易产生局部热点烫伤患者,同时设备安全保护功能失效;禁止仅用软管直接对皮肤送风加热,无升温毯隔离必然造成严重烫伤;

  2. 进气口严禁堵塞:主机底部进气滤网、通风口不可被床单、布单、墙面完全遮挡;堵塞进气会造成内部风机过热、加热模块故障,触发超温报警停机;设备禁止直接落地放置,必须抬高离地;

  3. 软管防护要求:送风软管不可弯折、挤压、重压;不可让患者身体压覆软管;软管全程不可直接接触患者裸露皮肤,必须通过升温毯隔绝热风;

  4. 皮肤全程监护:意识障碍、麻醉未苏醒、感觉缺失患者必须专人全程值守;每 10–15 分钟查看皮肤有无发红、发白、水泡等烫伤前兆;一旦出现皮肤异常立即停机移除升温毯;

  5. 过滤芯定期更换:每累计运行 500 小时或使用满 12 个月必须更换 MERV14 过滤芯;滤芯堵塞会降低送风流量、升温效率下降,同时滋生细菌污染送风;日常可清水冲洗滤芯,晾干后临时复用,到期强制更换;

  6. 电气安全规范:设备使用三孔接地电源插座;潮湿手术室、水疗区域使用时,避免主机、软管接触积水;禁止湿手插拔电源插头;设备不可与高频电刀、电凝器共用同一回路插座,避免电磁干扰故障;

  7. 设备禁止自行拆解改装:主机内部含高压加热组件、精密传感器,非 3M 授权工程师禁止拆机;私自拆解、改装设备将丧失全部质保,同时存在触电、起火安全隐患;

  8. 一次性耗材不可重复使用:升温毯为无菌一次性产品,重复使用会造成患者交叉感染;使用后毯体微孔堵塞、隔热层破损,易形成局部高温热点;

  9. 超温报警应急处置:设备触发超温声光报警时,立即断开电源,移开升温毯,通风散热;检查软管是否弯折堵塞、滤芯是否严重脏堵,排查故障后方可再次使用;

  10. 新生儿、儿童特殊管控:婴幼儿升温全程使用低档风速、32℃低温档,单次升温不超过 30 分钟;不可将升温毯包裹新生儿头部,仅覆盖躯干四肢,避免头部过度升温。

English

  1. Mandatory genuine OEM consumables: Only genuine single-use 3M warming blankets and gowns are approved for use. Non-standard third-party blankets exhibit uneven air permeability and heat distribution, creating localized hot spots that cause patient burns and disabling the unit’s built-in safety protections. Never deliver warm air directly to bare skin via the hose alone—severe thermal burns will occur without the insulating blanket barrier.

  2. Never block air intake vents: The intake filter and ventilation openings at the base of the unit must not be fully covered by linens, drapes or walls. Blocked intake airflow causes internal fan overheating and heating element failure, triggering over-temperature alarms and automatic shutdown. The unit must be elevated off the floor; direct floor placement is prohibited.

  3. Air hose protection requirements: Do not kink, crush or place heavy weight on the air delivery hose. Do not allow the patient’s body to lie on top of the hose. The hose must never make direct contact with the patient’s bare skin; the warming blanket must act as a thermal barrier at all times.

  4. Continuous cutaneous monitoring: Patients with impaired consciousness, incomplete anesthesia emergence or absent skin sensation require dedicated full-time clinical staff supervision. Inspect the patient’s skin every 10–15 minutes for early burn signs including erythema, blanching and blisters. Immediately shut down the unit and remove the warming blanket if abnormal skin changes appear.

  5. Regular filter replacement mandate: The MERV14 air filter must be replaced after every 500 cumulative operating hours or 12 months of service, whichever comes first. Clogged filters reduce airflow volume and warming efficiency, and allow bacterial colonization that contaminates delivered air. The filter may be rinsed with clean water and air-dried for temporary reuse, but full replacement is required upon reaching the service cycle limit.

  6. Electrical safety standards: The unit must be connected to a grounded 3-prong mains outlet. When operating in humid OR or hydrotherapy environments, prevent the main unit and air hose from contact with standing water. Do not plug/unplug the power cord with wet hands. Avoid sharing electrical circuits with high-frequency electrosurgical units to prevent electromagnetic interference malfunctions.

  7. No unauthorized disassembly or modification: The main unit contains high-voltage heating components and precision temperature sensors. Disassembly by non-3M authorized service engineers is prohibited. Unauthorized modification or teardown voids all warranty coverage and creates electric shock and fire hazards.

  8. Single-use consumables non-reusable rule: Warming blankets are sterile single-patient products. Reuse introduces severe cross-contamination infection risks. Post-use blankets exhibit clogged micropores and damaged thermal insulation layers that generate dangerous localized hot spots.

  9. Over-temperature alarm emergency protocol: When the unit triggers audible & visual over-temperature alarms, immediately disconnect mains power, remove the warming blanket and provide passive cooling ventilation. Inspect for kinked/clogged air hose and severely contaminated filter; resolve all faults before resuming clinical use.

  10. Special pediatric & neonatal control measures: Low airflow speed and 32°C Low temperature preset must be used exclusively for infant and neonatal warming sessions, with single treatment duration limited to 30 minutes maximum. Never wrap the neonatal head with the warming blanket; only cover the trunk and extremities to avoid excessive cranial heating.

九、存储条件 Storage Conditions

中文

  1. 环境温度:长期仓储、闲置存放环境温度 5℃~35℃;禁止存放于低于 0℃冷冻环境、高于 40℃高温区域(暖气旁、阳光直射窗台、设备机房高温区);极端高低温会老化内部塑料管路、传感器、加热丝,缩短设备使用寿命。

  2. 环境湿度:存储环境相对湿度 30%~80%,无冷凝水、无积水;禁止长期存放于潮湿地下室、清洗消毒间、水疗室等高湿区域;高湿环境会造成内部电路板受潮短路、金属接口锈蚀、风机轴承卡滞故障。

  3. 光照条件:避光存储,避免长期紫外线、强光直射;阳光直射会加速主机外壳、软管塑料材质老化变脆、开裂,显示屏背光组件加速损耗。

  4. 堆放搬运规范

    • 整机直立平稳存放,禁止倒置、侧放、多层重压堆叠;倒置会造成内部加热组件移位、风机平衡受损,软管接口松动漏气;

    • 设备搬运全程轻拿轻放,禁止暴力抛掷、重物碾压机身、软管;防止内部精密传感器断裂、加热丝变形、外壳开裂破损;

    • 软管收纳时平缓弯曲,禁止极限弯折、打结存放,避免管路内部风道塌陷堵塞。

  5. 仓储环境洁净度 存放区域保持干燥通风、无尘、无腐蚀性挥发性气体(含氯消毒蒸汽、甲醛、强酸强碱挥发气体、高浓度酒精雾气);腐蚀性气体会腐蚀金属电路触点、加热组件、滤芯滤网,造成设备性故障。

  6. 配件分类收纳 送风软管、备用过滤芯独立规整收纳;软管平整盘绕存放,避免长期扭曲变形;备用滤芯密封存放于干燥袋内,防止仓储积灰污染;一次性升温毯耗材单独存放于无菌储物柜,与主机设备分区存放,避免交叉污染。

  7. 长期闲置维护要求 设备连续闲置超过 30 天时,每月通电空载运行 10 分钟,激活内部电路、风机轴承,防止元器件受潮氧化;选配移动推车支架存放于干燥区域,避免金属支架生锈;闲置前清洁主机、软管、进气滤芯,干燥后再收纳存放。

English

  1. Ambient temperature: Long-term storage ambient temperature range 5°C~35°C. Storage in sub-zero freezing environments or high-temperature zones exceeding 40°C (adjacent to heating radiators, direct sunlight window sills, high-heat equipment rooms) is prohibited. Extreme high/low temperatures accelerate aging of internal plastic tubing, temperature sensors and heating filaments, shortening overall equipment service life.

  2. Ambient humidity: Storage relative humidity range 30%~80%, free of condensed water and standing water. Long-term storage in high-humidity areas including damp basements, disinfection cleaning rooms and hydrotherapy suites is forbidden. High humidity causes internal circuit board short-circuiting from moisture, corrosion of mmbedl connectors and seized fan bearing malfunctions.

  3. Light exposure requirements: Store away from direct light; avoid prolonged exposure to ultraviolet rays and intense bright light. Direct sunlight accelerates embrittlement and cracking of plastic chassis and hose materials, and prematurely degrades display backlight components.

  4. Stacking & transportation regulations

    • Store the unit upright and level; inversion, sideways placement and heavy multi-layer stacking are prohibited. Inversion displaces internal heating components, disrupts fan balance and loosens air hose connectors causing air leakage.

    • Handle the unit gently during all transportation; violent dropping and heavy object crushing of the chassis and hose are forbidden to prevent fractured precision internal sensors, deformed heating filaments and cracked outer housing.

    • Coil the air hose loosely for storage; extreme sharp bending and knotting are prohibited to avoid permanent collapse and blockage of the internal air channel.

  5. Warehouse cleanliness requirements Storage areas must remain dry, ventilated and dust-free, free of corrosive volatile fumes (chlorinated disinfectant vapor, formaldehyde, strong acid/alkali volatiles, high-concentration alcohol mist). Corrosive fumes etch mmbedl circuit contacts, heating assemblies and filter screens, leading to permanent irreversible equipment faults.

  6. Separated accessory storage Store air delivery hoses and spare replacement filters neatly and separately. Coil hoses flat to prevent permanent twisting deformation during long-term storage. Seal spare filters inside dry storage bags to prevent dust contamination during warehousing. Store disposable warming blanket consumables separately inside sterile storage cabinets, partitioned from the main warming units to avoid cross-contamination risks.

  7. Maintenance for long-term idle storage If the unit remains unused for more than 30 consecutive days, power on and run under no-load conditions for 10 minutes monthly to activate internal circuitry and fan bearings, preventing component oxidation from moisture. Store optional rolling cart brackets in dry areas to avoid mmbedl rusting. Thoroughly clean the main unit, air hose and intake filter prior to long-term idle storage, and fully air-dry all components before packing away.

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十、说明书核心信息 Manual Core Information

中文

1. 产品基础资质信息

通用名称:强制空气患者升温仪 商品名:3M Bair Hugger 升温系统 型号:Model 775(标准型)、Model 675(紧凑型基础型) 医疗器械分类:二类医用物理体温管理设备 生产企业:3M Company(美国 3M 公司) 执行安全标准:IEC 60601-1、UL60601 医用电气设备通用安全标准 灭菌说明:升温主机、软管为非无菌设备;一次性升温毯出厂环氧乙烷无菌灭菌,单人单次使用 包装规格:单机独立彩盒包装,配套软管;775 可选配四轮移动推车,675 配套壁挂支架;一次性升温毯独立无菌袋分装 质保期限:整机原厂质保 2 年;空气过滤芯、送风软管为消耗配件,不在整机质保范围内;一次性升温毯耗材无质保。

2. 整机结构组成

  1. 升温主机单元:底部进气过滤模块、直流送风风机、多路温度传感组件、恒温电热加热模块、主控电路板、数字显示操作面板、声光报警模块;

  2. 柔性送风软管:耐高温医用级 PVC 软管,内置温度感应探头(775 标配),两端快速插拔连接头;

  3. 一次性升温耗材:成人全身毯、半身毯、儿科专用毯、升温保暖袍,微孔透气散热结构;

  4. 可选配套附件:四轮移动推车(775 专用)、壁挂支架、输液杆夹持支架、备用 MERV14 过滤芯、加长送风软管。

3. 预期用途完整声明

本设备为强制对流热风体温管理设备,适用于各级医疗机构手术室、麻醉复苏室、ICU 重症监护、急诊抢救室、儿科病房;通过洁净恒温热风对流作用,对成人、儿童、新生儿实施体表升温干预,用于预防、治疗围手术期及创伤、休克引发的低体温症,维持患者正常核心体温,降低低体温相关手术切口感染、术中出血、麻醉后寒战等并发症发生概率;本设备仅允许具备执业资质医护人员操作使用,新生儿、婴幼儿、感觉障碍患者必须在专人全程监护下使用。

4. 核心强制安全声明

  1. 必须配套使用 3M 原厂一次性升温毯,禁止单独使用软管向皮肤送风加热,禁止搭配第三方非原厂升温耗材,违规使用将造成患者严重热烫伤,厂商不承担任何医疗事故责任;

  2. 主动脉阻断手术下肢升温为绝对禁忌症,严禁加热缺血肢体,否则造成不可逆肌肉、皮肤坏死;

  3. 进气通风口全程不可堵塞,设备禁止直接落地放置,堵塞进气会造成设备过热故障、超温报警停机;

  4. 设备运行期间软管不可直接接触患者裸露皮肤,软管不可重压、弯折、打结存放使用;

  5. 过滤芯必须按周期更换,堵塞脏污滤芯会降低升温效率、滋生细菌污染送风,存在交叉感染风险;

  6. 非 3M 授权专业工程师禁止拆解、改装、维修主机,私自拆机将直接丧失全部原厂质保,同时存在触电、起火安全隐患;

  7. 设备仅用于人体体表医疗升温干预,严禁用于动物保温、工业烘干、室内取暖等非医疗用途;

  8. 意识不清、麻醉未醒、皮肤感觉缺失、糖尿病神经病变患者使用本设备,必须安排医护人员全程持续监护,定时检查皮肤状态,防止深度烫伤。

5. 医疗废弃物废弃处置规范

  1. 升温主机整机报废:设备达到使用年限、核心电路 / 加热模块故障无法维修时,归类为医用电子废弃物,移交具备资质医疗设备回收机构拆解、无害化处置;禁止随意丢弃、私自拆解变卖内部电路板、金属元器件。

  2. 送风软管、过滤芯报废:软管老化开裂、滤芯堵塞破损无法清洗复用,归类为普通医用塑料废弃物,按医疗机构统一垃圾分类密封丢弃;接触创面、感染患者的软管、滤芯按感染性医疗废物处置。

  3. 一次性升温毯耗材处置:使用后的升温毯直接密封,按感染性医用废物集中焚烧处置,严禁清洗、消毒后重复使用。

  4. 金属支架、移动推车报废:金属配件锈蚀变形无法修复,按普通金属可回收废弃物统一回收处理。

6. 常见故障简易排查

  1. 通电无屏幕显示、整机无反应:检查电源线插头是否插紧、供电插座是否通电;检查设备底部电源开关是否开启;电源保险丝熔断需联系售后更换,禁止自行更换非标保险丝。

  2. 风机不送风、无气流输出:进气滤芯严重堵塞,拆下清洗 / 更换滤芯;软管两端接头松动脱落,重新插拔紧固;内部风机电机故障,联系授权售后检修。

  3. 风机正常送风,但无热风、仅常温风:加热模块故障、温度传感器脱落 / 损坏,触发加热保护停机;立即停机断电,禁止继续使用,联系售后维修。

  4. 频繁触发超温声光报警:软管严重弯折堵塞风道,理顺软管保证气流通畅;滤芯积灰严重堵塞进气,更换新滤芯;设备放置密闭狭小空间散热不良,转移至通风开阔区域使用;内部温控组件故障,售后检修校准。

  5. 屏幕故障代码、温度数值显示异常:温度感应探头脱落、线缆破损;主控电路板接触不良;断电静置 10 分钟重启自检,故障持续则联系售后检修。

English

1. Basic Product Qualification Information

Generic Name: Forced-Air Patient Warming Unit Trade Name: 3M Bair Hugger Warming System Models: Model 775 (Standard High-End Unit), Model 675 (Compact Basic Unit) Medical Device Classification: Class II Medical Physical Temperature Management Equipment Manufacturer: 3M Company (USA) Compliance Safety Standards: IEC 60601-1, UL60601 General Safety Standards for Medical Electrical Equipment Sterilization Note: Main warming unit and air hose are non-sterile devices. Disposable warming blankets are ethylene oxide sterile upon factory delivery, designated for single-patient single-use only. Packaging Specification: Individual color box packaging for each main unit with matching air hose. Model 775 is compatible with optional 4-wheel rolling carts; Model 675 includes matching wall-mount brackets. Disposable warming blankets are individually packed inside sterile pouches. Warranty Terms: 2-year original factory limited warranty for the main unit. Air filters and air delivery hoses are consumable accessories excluded from the main unit warranty. Disposable warming blanket consumables carry no manufacturer warranty.

2. Full Equipment Structural Composition

  1. Main warming unit assembly: Bottom intake filtration module, DC blower fan, multi-channel temperature sensing assembly, constant-temperature electric heating module, main control circuit board, digital display operation panel, audible & visual alarm module.

  2. Flexible air delivery hose: High-temperature resistant medical-grade PVC hose with built-in temperature sensing probe (standard for Model 775) and quick-disconnect plug connectors on both ends.

  3. Disposable warming consumables: Full-body adult blankets, half-body blankets, pediatric dedicated blankets, warming patient gowns with microporous breathable heat dissipation construction.

  4. Optional compatible accessories: 4-wheel rolling cart (Model 775 exclusive), wall-mount bracket, IV pole clamp bracket, spare MERV14 air filters, extended-length air delivery hoses.

3. Full Intended Use Statement

This forced convection warm air thermal management device is intended for use in operating rooms, post-anesthesia care units (PACU), ICUs, emergency resuscitation suites and pediatric wards of all levels of medical institutions. It delivers surface warming intervention to adults, children and neonates via clean constant-temperature warm air convection. It is indicated to prevent and treat hypothermia induced by perioperative procedures, traumatic injury and circulatory shock, maintain the patient’s normal core body temperature, and reduce the incidence of hypothermia-related complications including surgical site infection, intra-operative blood loss and post-anesthetic shivering. This device may only be operated by licensed medical clinical staff. Neonates, infants and patients with cutaneous sensory deficits require continuous full-time dedicated staff supervision during all warming sessions.

4. Mandatory Core Safety Statements

  1. Genuine single-use 3M warming blankets must be used in conjunction with the unit at all times. Delivering warm air directly to bare skin via the hose alone is strictly prohibited, as is the use of non-genuine third-party warming consumables. Improper usage will cause severe thermal burns to patients, and the manufacturer disclaims all liability for any medical adverse events arising from unauthorized accessory use.

  2. Warming the lower extremities during aortic cross-clamping is an absolute contraindication. Heating ischemic limbs will cause irreversible necrosis of limb muscle and cutaneous tissue.

  3. Intake ventilation openings must never be blocked during unit operation. Direct floor placement of the unit is prohibited. Blocked intake airflow causes internal unit overheating faults and automatic shutdown triggered by over-temperature alarms.

  4. The air delivery hose must never make direct contact with the patient’s bare skin during operation. Heavy compression, sharp bending and knotting of the hose during storage and clinical use are forbidden.

  5. Air filters must be replaced per the designated service cycle. Clogged contaminated filters reduce warming efficiency, enable bacterial colonization of delivered air and introduce cross-contamination infection risks.

  6. Disassembly, modification or repair of the main unit by non-3M authorized professional service engineers is prohibited. Unauthorized teardown immediately voids all original factory warranty coverage and creates electric shock and fire safety hazards.

  7. This device is solely intended for medical human body surface warming intervention. Non-medical applications including animal thermal support, industrial drying and indoor space heating are strictly forbidden.

  8. Patients with impaired consciousness, incomplete anesthesia emergence, complete loss of cutaneous sensation and diabetic peripheral neuropathy require continuous full-time clinical staff monitoring during all warming sessions. Skin condition must be inspected at regular intervals to prevent painless deep thermal burns.

5. Medical Equipment Waste Disposal Guidelines

  1. Main unit end-of-life scrappage: When the unit reaches its service lifespan or suffers irreparable faults in core circuitry or heating assemblies, classify the full unit as electronic medical waste. Deliver to certified medical equipment recycling facilities for disassembly and harmless disposal. Random discard and unauthorized disassembly for resale of internal circuit boards and mmbedl electronic components are prohibited.

  2. Air hose & filter scrappage: Air hoses with aging cracks and clogged damaged filters that cannot be cleaned for reuse are classified as general medical plastic waste and sealed for disposal per hospital unified waste sorting protocols. Hoses and filters that have contacted open wounds or infectious patients must be disposed of as infectious medical waste.

  3. Disposable warming blanket consumable disposal: Seal used warming blankets immediately upon completion of treatment and dispose of them collectively via incineration as infectious medical waste. Cleaning, disinfection and reuse of single-use blankets are strictly prohibited.

  4. Metal brackets & rolling cart scrappage: Rust-deformed mmbedl accessories that cannot be repaired are classified as recyclable general mmbedl waste for unified recycling and processing.

6. Simple Troubleshooting for Common Malfunctions

  1. No display upon power-on, unit completely unresponsive: Verify secure power cord connection and energized wall outlet; confirm the power switch at the base of the unit is turned ON. Blown internal power fuses require replacement by authorized service personnel; self-replacement of non-standard fuses is forbidden.

  2. Fan operates with zero airflow output: Intake filter is severely clogged; remove, clean or replace the filter. Loose disconnected hose connectors; re-seat and secure both hose ends. Internal fan motor failure; contact authorized after-sales service for maintenance.

  3. Fan delivers normal airflow but no warm air (only ambient-temperature air): Heating assembly fault or detached/damaged temperature sensors trigger heating safety shutdown. Immediately power off and disconnect the unit; discontinue clinical use and contact service engineers for repair.

  4. Frequent repeated audible & visual over-temperature alarms: Severely kinked hose blocks internal air channel; straighten the hose to restore unobstructed airflow. Heavily dust-clogged intake filter; install a brand-new replacement filter. Unit placed inside a confined small space with poor heat dissipation; relocate the unit to a well-ventilated open clinical area. Faulty internal temperature control components; arrange service calibration and repair.

  5. Fault codes displayed on screen, abnormal temperature readouts: Detached temperature sensing probe or damaged probe wiring; poor contact of main control circuit board. Power off the unit and allow 10 minutes of rest before rebooting to initiate self-test diagnostics. If fault conditions persist after restart, contact authorized after-sales service for inspection and repair.
    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:厂家供应3M患者升温系统775675,775升温,3M患者升温系统

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