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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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史密斯加温毯

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品牌名称:$brandModel.Title型号: 原产地:中国大陆 更新时间:2026/10/16 11:11:09

产品摘要:史密斯加温毯

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详细内容

史密斯加温毯史密斯加温毯史密斯加温毯史密斯加温毯史密斯加温毯
史密斯加温毯史密斯加温毯史密斯加温毯史密斯加温毯史密斯加温毯






一、工作原理 Working Principle

中文

整套设备由对流加温主机 + 输风软管 + 一次性对流加温毯三部分组成,采用强制热风对流加温原理。

  1. 主机风机吸入环境空气,空气流经内置电热元件完成加热;

  2. 软管末端搭载热敏电阻伺服控温,实时监测输出热风温度,主机电路动态调节加热功率,稳定维持设定温度,不受手术室环境温度干扰;

  3. 加温后的恒温热风通过 2.1m 输风软管输送至一次性加温毯内部风道;

  4. 加温毯布满均匀散风微孔,热风缓慢、均匀扩散至患者体表,在皮肤表层形成一层温热空气保护层,阻断皮肤辐射、对流散热,提升体表温度、维持患者核心体温;

  5. 设备配备独立双路安全温控系统:一路为主控伺服温控,一路为独立安全热敏电阻,一旦热风超温,安全回路立即切断加热与风机电源,同步声光报警,杜绝烫伤风险。

English

The complete system consists of three components: Level1 convective warmer host, air delivery hose and single-use convective warming blanket, adopting forced hot air convection warming principle.

  1. The built-in fan of the host draws ambient air, which is heated after passing through internal electric heating elements.

  2. A thermistor at the hose outlet performs servo temperature control, real-time monitoring the temperature of output hot air. The host circuit dynamically adjusts heating power to steadily maintain the set temperature, unaffected by operating room ambient temperature.

  3. Constant-temperature hot air is delivered to the internal air duct of the disposable warming blanket through a 2.1m air delivery hose.

  4. The warming blanket is covered with uniform air-diffusion micropores. Hot air spreads slowly and evenly over the patient’s body surface, forming a warm air protective layer on the skin surface to block radiative and convective heat loss of skin, raise body surface temperature and maintain the patient’s core body temperature.

  5. The device is equipped with an independent dual-channel safety temperature control system: one channel for main servo temperature control, another for independent safety thermistor. Once hot air overheats, the safety circuit immediately cuts off power to heating elements and fan, with simultaneous audio-visual alarm to eliminate scald risk.

二、产品功能 Product Functions

中文

  1. 围手术期主动保温:术前预加温、术中持续恒温、术后复苏复温,预防和治疗患者低体温(核心体温<36℃);

  2. 多档位控温:4 档热风输出(室温风、36℃、40℃、44℃),适配新生儿、老年、常规手术、重度低体温等不同患者场景;

  3. 全流程安全防护:超温保护、管路堵塞报警、整机开机自检、故障声光报警、过热自动断电;

  4. 体表均匀热防护:热风全域均匀扩散,无局部高温,减少寒战、凝血异常、切口感染、苏醒延迟等低体温并发症;

  5. 适配全科室临床场景:手术室、麻醉复苏室、ICU、急诊、新生儿科、透析室、烧伤病房;

  6. 一次性毯体隔离防护:单人单用加温毯,避免患者间交叉感染;

  7. 低噪音稳定送风:低噪风机设计,运行噪音 40~45dBA,不干扰手术室操作与监护信号;

  8. 配套管路固定配件:床单卡扣、软管收纳卷,固定管路防止弯折、受压堵塞风道。

English

  1. Perioperative active thermal protection: Preoperative pre-warming, intraoperative continuous constant temperature, post-anesthesia recovery rewarming, to prevent and treat patient hypothermia (core temperature <36℃).

  2. Multi-level precise temperature control: 4 levels of hot air output (ambient air, 36℃, 40℃, 44℃), suitable for different patient scenarios including neonates, elderly patients, routine surgeries and severe hypothermia patients.

  3. Full-process safety protection: Over-temperature protection, hose occlusion alarm, automatic power-on self-test, audio-visual fault alarm and automatic power-off upon overheating.

  4. Uniform whole-body surface thermal protection: Even full-area hot air diffusion without local high temperature, reducing hypothermia complications such as shivering, coagulation disorders, surgical site infection and delayed anesthesia recovery.

  5. Compatible with full clinical departments: Operating room, PACU, ICU, emergency department, neonatology, dialysis unit and burn ward.

  6. Isolation protection via single-use blanket: One blanket for one patient only to avoid cross-infection between patients.

  7. Low-noise stable air supply: Low-noise fan design with operating noise 40~45dBA, no interference to OR operations and monitoring signals.

  8. Matching pipeline fixing accessories: Sheet clips and hose cord wrap to fix tubing and prevent duct kinking or compression occlusion.

三、产品特点 Product Features

中文

  1. 双路独立安全温控系统:主控 + 独立安全热敏电阻双重防护,超温强制断电报警,符合 IEC 医用电气安全标准ManualsLib;

  2. 四档标准化临床温控:36℃温和档、40℃标准手术档、44℃重度低体温复温档、室温风档,覆盖全部临床需求;

  3. 高精度软管末端测温:热风输出口直接测温,控温精度 ±1℃,不受环境冷热干扰,升温至 36℃仅需 7 分钟;

  4. 一次性 SW 系列加温毯无菌独立包装:分为全身通用、下肢专用、新生儿专用多规格,防水透气微孔面料,热风均匀不散漏;

  5. 低噪静音风机:运行噪音≤45 分贝,术中不影响医护沟通与生命体征监护;

  6. 0.2µm 空气过滤系统:过滤空气中粉尘、皮屑,洁净热风,降低呼吸道刺激与创面感染风险;

  7. 整机轻量化便携:主机净重 6.8kg,可挂载输液杆、配套移动推车,灵活放置手术床边;

  8. 全管路防弯折自锁接口:软管两端卡扣式自锁连接,安装便捷,不会脱落漏气;

  9. 无易燃发热隐患:主机电热元件隔离设计,禁止可燃麻醉气体环境外使用,防爆安全结构;

  10. 人机友好操作面板:LED 指示灯直观显示待机、温度档位、故障报警,开机自动整机自检,操作简单易上手。

English

  1. Dual-channel independent safety temperature control system: Dual protection of main control and independent safety thermistor, forced power-off and alarm upon overheating, complying with IEC medical electrical safety standardsManualsLib.

  2. Four-level standardized clinical temperature control: 36℃ mild level, 40℃ standard surgical level, 44℃ severe hypothermia rewarming level and ambient air level, covering all clinical demands.

  3. High-precision temperature measurement at hose outlet: Direct temperature detection at hot air outlet with control accuracy ±1℃, unaffected by hot or cold environment; only 7 minutes required to heat up to 36℃.

  4. Single-use SW series warming blanket with sterile individual packaging: Multiple specifications including full-body universal, lower-limb dedicated and neonatal dedicated. Waterproof and breathable micropore fabric ensures even hot air diffusion without leakage.

  5. Low-noise silent fan: Operating noise ≤45 decibels, no interference to medical staff communication and vital sign monitoring during surgery.

  6. Long-lasting 0.2µm air filtration system: Filters dust and dandruff in air to deliver clean hot air, reducing risks of respiratory irritation and surgical site infection.

  7. Lightweight portable host: Net weight 6.8kg, can be mounted on IV poles or matched with mobile trolley, flexibly placed beside operating tables.

  8. Kink-resistant self-locking connectors for full pipeline: Buckle-type self-locking connection at both ends of hose for easy installation without disconnection or air leakage.

  9. No flammable heating hazards: Isolated heating element design inside host; prohibited for use in environments with flammable anesthetic gas, with explosion-proof safety structure.

  10. User-friendly operation panel: LED indicators intuitively display standby status, temperature levels and fault alarms. Automatic full-machine self-test upon power-on for simple and easy operation.

四、技术参数 Technical Specifications

中文

  1. 设备型号:主机 EQ-5000(Level1 Equator);加温毯 SW 系列一次性对流加温毯

  2. 医疗器械类别:第二类进口医用设备

  3. 热风温度档位:室温风、36℃、40℃、44℃,控温精度 ±1℃

  4. 输风软管规格:长度 2.1m(7 英尺),自锁卡扣接口

  5. 空气过滤精度:0.2µm 高效过滤器

  6. 运行噪音:40~45dBA

  7. 升温速度:环境 20℃升温至 36℃平均 7 分钟

  8. 主机净重:6.8kg

  9. 整机尺寸:高度 117cm

  10. 供电标准:医用交流电源 AC220V 50Hz

  11. 安全防护:双路独立热敏电阻超温断电保护、管路堵塞声光报警、整机开机自检

  12. 加温毯规格:全身通用毯、下肢加温毯、新生儿小型加温毯,单人一次性无菌使用

  13. 存储温湿度:5℃~40℃,相对湿度 5%~95%,无凝露环境

  14. 安全标准:符合 IEC 80601-2-35 医用加温设备安全规范

English

  1. Model: Host EQ-5000 (Level1 Equator); Warming Blanket: SW series single-use convective warming blanket

  2. Medical Device Classification: Class II imported medical equipment

  3. Hot Air Temperature Levels: Ambient air, 36℃, 40℃, 44℃; Temperature control accuracy ±1℃

  4. Air Delivery Hose Spec: Length 2.1m (7ft), self-locking buckle connector

  5. Air Filtration Precision: 0.2µm high-efficiency filter

  6. Operating Noise: 40~45dBA

  7. Heating Rate: Average 7 minutes to heat ambient air from 20℃ to 36℃

  8. Host Net Weight: 6.8kg

  9. Overall Height: 117cm

  10. Power Supply Standard: Medical AC power AC220V 50Hz

  11. Safety Protection: Dual-channel independent thermistor over-temperature power-off protection, audio-visual alarm for hose occlusion, automatic full-machine power-on self-test

  12. Warming Blanket Sizes: Full-body universal blanket, lower-limb warming blanket, small neonatal warming blanket; single-use sterile for one patient only

  13. Storage Temperature & Humidity: 5℃~40℃, relative humidity 5%~95%, non-condensing environment

  14. Safety Standard: Compliant with IEC 80601-2-35 safety specification for medical warming devices

五、使用方法 Operation Procedures

中文

(一)术前设备准备

  1. 检查主机外观无破损、电源线完好,放置平稳,远离酒精、碘伏等易燃消毒剂;

  2. 将 2.1m 输风软管一端卡扣接入主机出风口,另一端连接一次性加温毯进气口,确认卡扣锁紧无漏气;

  3. 安装 0.2µm 空气过滤器,检查过滤芯无堵塞、无破损;

  4. 接通医用接地电源,主机自动整机自检,全部 LED 指示灯依次亮起,自检完成后待机绿灯常亮ManualsLib;

  5. 术前 10~15 分钟开机,根据患者类型选择温度档位,预吹热风建立体表保温层。

(二)加温毯铺设规范

  1. 根据患者年龄、手术部位选择适配规格加温毯:新生儿用小号毯、下肢手术用下肢专用毯、全身大手术用通用全身毯;

  2. 加温毯平铺于手术床,仅覆盖患者完整皮肤区域,严格避开手术切口、创面、引流管、心电电极、起搏器植入部位;

  3. 禁止加温毯遮盖患者口鼻、面部,热风不得直吹呼吸道;

  4. 使用床单卡扣固定加温毯边缘,防止术中毯体移位、滑落;

  5. 一次性加温毯单人单用,开封后立即使用,使用完毕即丢弃,不可重复使用。

(三)温度档位选择与运行监护

  1. 新生儿、高龄衰弱、麻醉感觉迟钝患者:选择 36℃温和档,低风量运行,全程监测皮肤温度;

  2. 常规全麻、中小型手术患者:40℃标准档位,临床通用保温模式;

  3. 入室低体温、创伤大出血、长时间心胸 / 移植手术:44℃复温档位,快速纠正低体温;

  4. 仅通风无加温需求:选择室温风档位;

  5. 术中持续监护患者核心体温(食管温、鼻咽温、肛温),每 30 分钟观察患者体表皮肤,排查泛红、发白、烫伤前兆;

  6. 若主机触发超温 / 管路堵塞报警,立即切换至室温风档,检查软管有无弯折、毯体微孔是否堵塞,故障排除后再恢复加温。

(四)术后关机收尾

  1. 手术结束后,先切换至室温风档位运行 3~5 分钟,排出管路内热空气;

  2. 关闭主机电源,拔下电源线,依次断开加温毯、输风软管卡扣接口;

  3. 一次性加温毯按医疗感染性废物密封丢弃;

  4. 清洁主机外壳、软管外表面,存放至干燥无尘储物区;

  5. 每周更换空气过滤芯,清理风机内部积尘,完成设备日常维护。

English

(1) Pre-operation Equipment Preparation

  1. Inspect host for intact appearance and undamaged power cord; place stably and keep away from flammable disinfectants such as alcohol and iodophor.

  2. Buckle one end of 2.1m air delivery hose into host air outlet, connect the other end to air inlet of single-use warming blanket, confirm tight buckle without air leakage.

  3. Install 0.2µm air filter, inspect filter element for no blockage or damage.

  4. Connect to medical grounded power supply; the host performs automatic full-machine self-test with all LED indicators lighting sequentially. Green standby light stays steady after self-test completionManualsLib.

  5. Power on 10~15 minutes before surgery, select temperature level according to patient type, pre-blow hot air to build body surface thermal protective layer.

(2) Warming Blanket Laying Standard

  1. Select matching blanket size based on patient age and surgical site: small blanket for neonates, lower-limb dedicated blanket for lower-extremity surgery, full-body universal blanket for major whole-body surgery.

  2. Lay warming blanket flat on operating table, only cover patient’s intact skin areas; strictly avoid surgical incisions, wounds, drainage tubes, ECG electrodes and pacemaker implantation sites.

  3. Prohibit covering patient’s mouth, nose and face with blanket; hot air shall not blow directly to respiratory tract.

  4. Fix blanket edges with sheet clips to prevent shifting or slipping during surgery.

  5. Single-use warming blanket for one patient only; use immediately after opening package and discard after use, reuse is forbidden.

(3) Temperature Level Selection & Intraoperative Monitoring

  1. Neonates, elderly debilitated patients and patients with dull anesthesia sensation: select 36℃ mild level with low air volume; continuously monitor skin temperature throughout use.

  2. Patients under routine general anesthesia and minor/medium surgeries: 40℃ standard level, universal clinical thermal protection mode.

  3. Patients admitted with hypothermia, traumatic massive hemorrhage, long-duration cardiac/thoracic or transplant surgeries: 44℃ rewarming level to rapidly correct hypothermia.

  4. Ambient air level for ventilation only without heating demand.

  5. Continuously monitor patient core temperature (esophageal, nasopharyngeal or rectal temperature) during surgery; observe patient body surface skin every 30 minutes to check for erythema, pallor or early scald signs.

  6. If host triggers over-temperature or hose occlusion alarm, immediately switch to ambient air level, check for kinked hose or blocked blanket micropores; resume heating only after fault elimination.

(4) Post-operation Shutdown & Tidy-up

  1. After surgery completion, switch to ambient air level and run for 3~5 minutes to exhaust hot air inside pipelines.

  2. Turn off host power, unplug power cord, disconnect buckle connectors of warming blanket and air hose sequentially.

  3. Seal and discard single-use warming blanket as infectious medical waste.

  4. Clean host shell and outer surface of hose, store in dry and dust-free storage area.

  5. Replace air filter element weekly, clean dust accumulated inside fan to complete daily equipment maintenance.

六、适应症 Indications

中文

  1. 预防围手术期低体温:适用于全身麻醉、椎管内麻醉各类手术患者,阻断术中皮肤散热,维持核心体温≥36℃;

  2. 治疗已发生低体温:用于创伤、失血性休克、溺水、重症感染、大面积烧伤导致核心体温低于 36℃的患者快速复温;

  3. 麻醉术后寒战干预:PACU 麻醉复苏室患者,缓解术后寒战,缩短麻醉苏醒时间,降低心律失常、血压波动风险;

  4. 重症监护恒温护理:ICU/CCU 脓毒症、多发创伤、术后体温不升危重患者持续体表保温;

  5. 新生儿 / 儿科围术期保温:早产儿、低体重儿、婴幼儿手术,弥补婴幼儿体温调节能力不足;

  6. 其他临床场景:血液透析全程保温、长时间内镜检查、烧伤换药、长期卧床康复患者体表恒温防护;

  7. 高流失热风险人群:老年人、甲状腺功能减退、体质虚弱、术前基础体温偏低患者全程保温管理。

English

  1. Prevention of perioperative hypothermia: Applicable to patients under general anesthesia or neuraxial anesthesia for all types of surgeries; block intraoperative skin heat loss and maintain core temperature ≥36℃.

  2. Treatment of established hypothermia: Rapid rewarming for patients with core temperature below 36℃ caused by trauma, hemorrhagic shock, drowning, severe infection and extensive burns.

  3. Intervention for post-anesthesia shivering: For patients in PACU post-anesthesia care unit to relieve postoperative shivering, shorten anesthesia recovery time and reduce risks of arrhythmia and blood pressure fluctuation.

  4. Constant-temperature nursing for critical care: Continuous body surface thermal protection for critically ill patients with sepsis, multiple traumas and persistent low body temperature after surgery in ICU/CCU.

  5. Perioperative thermal protection for neonates and pediatrics: Surgery for premature infants, low-birth-weight infants and young children to compensate for insufficient thermoregulation ability of infants.

  6. Other clinical scenarios: Full-process thermal protection during hemodialysis, long-duration endoscopic examination, burn dressing change and constant-temperature body surface protection for long-term bedridden rehabilitation patients.

  7. Population with high heat loss risk: Full-process thermal management for elderly patients, hypothyroidism patients, debilitated patients and patients with low baseline body temperature before surgery.

七、禁忌症 Contraindications

中文

绝对禁忌(严禁使用加温毯加温)

  1. 加温区域存在缺血、无灌注组织:主动脉阻断远端肢体、重度外周血管闭塞、血管结扎后末梢组织,热风加温会加重组织缺血、诱发皮肤坏死、烫伤;

  2. 加温区域皮肤破损、创面、活动性感染、皮炎、皮肤溃疡、烧伤新鲜创面,热风刺激会加重创面渗出、感染扩散;

  3. 皮肤完全感觉丧失患者:重度神经损伤、脊髓横断、深度昏迷温觉,无法感知过热,极易发生烫伤;

  4. 设备周边存在易燃、易爆麻醉混合气体(空气 / 氧气 / 笑气混合可燃麻醉剂),主机电热元件存在引燃爆炸风险ManualsLib。

相对禁忌(谨慎使用,全程专人严密监护)

  1. 严重心力衰竭、不稳定型心绞痛、心梗急性期患者,复温后外周血管扩张易诱发血压骤降、心律失常;

  2. 严重凝血功能障碍、活动性全身出血患者,体表加温扩张外周血管,加重出血风险;

  3. 新生儿超低体重儿(<1000g),皮肤极薄,仅可使用 36℃最低温和档,全程持续监测皮肤温度;

  4. 长期大量使用缩血管药物(去甲肾上腺素等)患者,肢体末梢血管持续强烈收缩,局部循环极差,加温易造成皮肤损伤。

English

Absolute Contraindications (Warming blanket heating strictly prohibited)

  1. Ischemic, non-perfused tissue within heating area: Distal limbs after aortic cross-clamping, severe peripheral vascular occlusion and distal tissue after vessel ligation; hot air heating aggravates tissue ischemia and induces skin necrosis or scald.

  2. Broken skin, wounds, active infection, dermatitis, skin ulcers and fresh burn wounds in heating area; hot air irritation aggravates wound exudation and infection spread.

  3. Patients with complete loss of skin sensation: Severe nerve injury, spinal cord transection and deep coma without pain/temperature sensation, unable to sense overheating and prone to painless scalds.

  4. Flammable and explosive anesthetic mixed gas (combustible anesthetics mixed with air/oxygen/nitrous oxide) around equipment; heating elements inside host carry ignition and explosion risksManualsLib.

Relative Contraindications (Use with extreme caution under full-time dedicated close monitoring)

  1. Patients with severe heart failure, unstable angina and acute myocardial infarction; peripheral vasodilation after rewarming may induce sudden blood pressure drop and arrhythmia.

  2. Patients with severe coagulation disorders and active systemic hemorrhage; body surface heating dilates peripheral blood vessels and aggravates bleeding risk.

  3. Extremely low birth weight neonates (<1000g) with extremely thin skin; only the lowest mild level of 36℃ is allowed with continuous full-process skin temperature monitoring.

  4. Patients receiving long-term high-dose vasoconstrictor drugs (norepinephrine etc.) with persistent severe peripheral vasoconstriction and extremely poor local circulation; heating easily causes skin injury.

八、注意事项 Precautions

中文

(一)设备操作安全注意

  1. 设备仅可由经过专业培训的医护人员操作,禁止无资质人员、患者及家属操作主机;

  2. 主机必须连接可靠医用接地电源,禁止使用无接地、老化破损电源线,避免漏电电击风险;

  3. 运行中禁止覆盖、封堵主机进风口、出风口,禁止弯折、挤压输风软管,风道堵塞会触发高温报警,甚至损坏主机加热元件;

  4. 每次使用前检查空气过滤器,滤芯堵塞、发黑、破损立即更换,脏污滤芯会降低热风洁净度、阻碍气流;

  5. 严禁将加温毯直接紧贴患者皮肤长时间覆盖,毯体与皮肤间可垫单层无菌中单,隔绝热风直吹降低烫伤风险;

  6. 不可将输液管路、引流管、电极线压在加温毯下方,管路受压弯折会造成输液不畅、引流堵塞、心电信号干扰;

  7. 设备故障出现持续高温、异响、冒烟、焦糊气味时,立即切断总电源,停止使用,联系厂家售后检修,禁止自行拆机维修。

(二)患者安全监护注意

  1. 麻醉、镇静、婴幼儿、老年、感觉迟钝患者为烫伤高风险人群,每 30 分钟必须掀开加温毯一角观察皮肤状态,出现皮肤泛红、发白、水泡立即停止加温,冷敷对症处理;

  2. 禁止热风直吹患者面部、口鼻、呼吸道,避免热风刺激气道黏膜引发呛咳、气道干燥不适;

  3. 严格控制加温时长,同一部位连续加温不超过 4 小时,长时间局部加温会持续扩张皮肤血管,提升烫伤、皮下水肿风险;

  4. 围术期持续监测患者核心体温,目标维持 36℃~37℃,若核心体温升至 37.8℃以上,立即调低温度档位或切换室温风,防止过热。

(三)耗材与院感防控注意

  1. SW 系列加温毯为一次性无菌耗材,单人单用,使用后不可清洗、消毒、重复复用,避免交叉感染;

  2. 加温毯独立无菌包装破损、漏气、受潮时禁止临床使用,包装破损会破坏无菌屏障;

  3. 主机外壳、输风软管外表面每次使用后用医用季铵盐类消毒剂擦拭消毒,禁止直接喷淋液体冲洗主机机身,防止液体渗入电路造成短路损坏;

  4. 废弃加温毯沾染患者血液、体液,按照感染性医疗废物密封投放,统一合规处置。

(四)存储与环境使用注意

  1. 主机放置远离水源、喷淋消毒区域,不可放置潮湿地下室、清洗间,防止电路受潮短路;

  2. 手术室使用时远离高频电刀、射频消融设备,高频电磁信号会干扰主机温控电路,引发温度异常波动ManualsLib;

  3. 禁止在 MRI 核磁检查室内使用本加温系统,金属主机、管路会干扰核磁成像,同时存在电磁设备安全隐患。

English

(1) Equipment Operation Safety Precautions

  1. The equipment shall only be operated by professionally trained medical staff; operation by unqualified personnel, patients or their families is prohibited.

  2. The host must be connected to reliable medical grounded power supply; use of ungrounded, aged or damaged power cords is forbidden to avoid electric leakage and shock risks.

  3. Do not cover or block the air inlet and outlet of the host during operation; do not kink or compress the air delivery hose. Blocked air duct triggers high-temperature alarm and may even damage host heating elements.

  4. Inspect air filter before each use; replace filter element immediately if clogged, blackened or damaged. Dirty filter reduces hot air cleanliness and obstructs airflow.

  5. Prohibit long-term direct contact coverage of warming blanket on patient skin; a single layer of sterile sheet can be padded between blanket and skin to isolate direct hot air blow and reduce scald risk.

  6. Do not press infusion tubes, drainage tubes and electrode wires under the warming blanket; compressed and kinked pipelines cause poor infusion, blocked drainage and ECG signal interference.

  7. Immediately cut off main power supply and stop use if equipment malfunctions with persistent high temperature, abnormal noise, smoke or burnt odor; contact manufacturer after-sales service for maintenance, self-disassembly and repair are prohibited.

(2) Patient Safety Monitoring Precautions

  1. Anesthetized, sedated, infant, elderly and hypoesthetic patients carry high scald risk; lift a corner of the warming blanket to inspect skin condition every 30 minutes. Stop heating immediately and apply cold compress for symptomatic treatment if skin erythema, pallor or blisters appear.

  2. Prohibit direct hot air blow to patient’s face, mouth, nose and respiratory tract to avoid airway mucosa irritation causing coughing and dry airway discomfort.

  3. Strictly control heating duration; continuous heating on the same body part shall not exceed 4 hours. Long-term local heating continuously dilates skin blood vessels and raises risks of scald and subcutaneous edema.

  4. Continuously monitor patient core temperature perioperatively with target maintenance at 36℃~37℃. If core temperature rises above 37.8℃, immediately lower temperature level or switch to ambient air to prevent overheating.

(3) Consumable & Hospital Infection Control Precautions

  1. SW series warming blankets are single-use sterile consumables for one patient only; cleaning, disinfection and reuse after use are forbidden to avoid cross-infection.

  2. Clinical use is prohibited if the individual sterile packaging of warming blanket is damaged, leaking air or damp; damaged packaging destroys sterile barrier.

  3. Wipe and disinfect host shell and outer surface of air hose with medical quaternary ammonium disinfectant after each use; direct liquid spray flushing of host body is forbidden to prevent liquid infiltration into circuits causing short circuit and damage.

  4. Discarded warming blankets contaminated with patient blood or body fluids shall be sealed and disposed of as infectious medical waste in standardized compliant manner.

(4) Storage & Environmental Usage Precautions

  1. Place host far from water sources and spray disinfection areas; do not store in damp basements or cleaning rooms to prevent circuit dampness and short circuit.

  2. Keep away from high-frequency electrosurgical units and radiofrequency ablation devices when used in operating rooms; high-frequency electromagnetic signals interfere with host temperature control circuits and cause abnormal temperature fluctuationsManualsLib.

  3. This warming system is prohibited for use inside MRI examination rooms; mmbedl host and pipelines interfere with MRI imaging and carry electromagnetic equipment safety hazards.

九、存储条件 Storage Conditions

中文

  1. 温度范围:长期存储环境温度 5℃ ~ 40℃,禁止存放于低于 5℃低温冷冻环境、高于 40℃高温暴晒环境;

  2. 湿度范围:存储环境相对湿度 5% ~ 95%,库房无凝露、无积水,杜绝潮湿环境造成主机电路受潮短路、加温毯无菌包装受潮破损;

  3. 光照要求:避光存储,远离阳光直射、紫外线消毒灯长期照射,避免主机塑料外壳老化、加温毯包装印刷褪色、面料老化变脆;

  4. 环境洁净度:存储库房保持干燥通风、无尘、无粉尘堆积;远离甲醛、酒精、消毒烟雾、酸碱腐蚀性化学试剂存放区域,腐蚀性气体会腐蚀设备金属部件、破坏无菌耗材包装;

  5. 堆叠放置规范:主机、耗材纸箱水平平放堆叠,禁止倒置、侧放、重压堆叠;耗材纸箱堆叠高度不超过 5 层,防止底层加温毯包装挤压破损、无菌失效;

  6. 仓储分区隔离:加温主机与一次性加温毯耗材分区存放,不可与消杀药品、腐蚀性化学品、生活垃圾混放;

  7. 闲置设备存储维护:设备长期闲置超过 1 个月,需每周通电空载运行 10 分钟,驱散设备内部潮气,防止电路、风机元件受潮锈蚀;

  8. 运输临时存储:设备运输全程做好防潮、防震、避光防护,外包装加装防震泡沫缓冲,避免雨淋、剧烈撞击、重物挤压;中转临时存储严格遵循上述长期存储温湿度、洁净环境标准。

English

  1. Temperature Range: Long-term storage ambient temperature 5℃ ~ 40℃. Storage in freezing environment below 5℃ or high-temperature sun-exposed environment above 40℃ is prohibited.

  2. Humidity Range: Storage environment relative humidity 5% ~ 95%, warehouse free of condensation and water accumulation. Damp environment is forbidden to avoid host circuit short circuit caused by moisture and damage to sterile packaging of warming blankets.

  3. Light Requirement: Store away from light, keep far from direct sunlight and long-term UV disinfection lamp irradiation to prevent aging of host plastic shell, fading of printed patterns on blanket packaging and embrittlement of fabric material.

  4. Environmental Cleanliness Requirement: Storage warehouse shall be dry, ventilated and dust-free without accumulated dust; keep separated from storage zones of formaldehyde, alcohol, disinfection fume and acid-base corrosive chemical reagents. Corrosive gas corrodes mmbedl components of equipment and damages packaging of sterile consumables.

  5. Stacking Standard: Lay host and consumable cartons horizontally for stacking; inversion, lateral placement and heavy compression stacking are prohibited. Stack height of consumable cartons shall not exceed 5 layers to prevent extrusion rupture of bottom warming blanket packaging and loss of sterility.

  6. Warehouse Zoning Isolation: Store warming host and single-use warming blanket consumables in separate designated zones; mixing storage with disinfection chemicals, corrosive reagents and domestic waste is forbidden.

  7. Maintenance for Idle Equipment Storage: If equipment is left idle for more than 1 month, power on and run under no load for 10 minutes weekly to dispel internal moisture and prevent damp rust of circuits and fan components.

  8. Temporary Transit Storage: Equip full moisture-proof, shock-proof and light-proof protection during equipment transportation with shock-absorbing foam buffer on outer package; avoid rain exposure, severe impact and heavy object extrusion. Temporary transit storage shall strictly comply with the above long-term storage standards for temperature, humidity and clean environment.

十、说明书核心总览 Core Manual Summary

中文

史密斯 Level1 EQ-5000 对流加温系统为二类进口医用体表加温设备,整套由对流加温主机、2.1m 输风软管、SW 系列一次性无菌对流加温毯组成,采用强制热风对流加温技术,搭载双路独立安全温控回路,四档标准化热风输出(室温 / 36℃/40℃/44℃),控温精度 ±1℃,快速阻断患者皮肤辐射、对流散热,预防并治疗围手术期低体温,减少寒战、切口感染、凝血异常、麻醉苏醒延迟等临床并发症。 设备适用于手术室、麻醉复苏室、ICU、急诊、新生儿科、透析室等全临床科室,覆盖成人、老年、婴幼儿、创伤休克、重症感染等各类低体温高风险人群;存在缺血无灌注组织、皮肤破损创面、完全感觉丧失、可燃麻醉气体环境时绝对禁止使用;重度心衰、凝血障碍、超低体重早产儿、长期缩血管药物使用者需谨慎使用并全程专人监护。 加温毯为单人一次性无菌耗材,不可重复使用;操作仅允许专业医护人员执行,术中需定时监测患者皮肤与核心体温,规避烫伤风险;设备存储需维持 5~40℃、湿度 5%~95% 避光干燥无尘环境,远离腐蚀试剂与高频电磁设备,闲置设备每周通电驱潮维护;设备故障需联系官方售后检修,禁止自行拆机。 整套系统运行噪音低、配备 0.2µm 高效空气过滤、管路自锁防漏气,具备开机自检、超温断电、管路堵塞声光报警多重安全防护,符合 IEC 医用加温设备安全标准,是临床围手术期体温管理标准化设备。

English

Smiths Medical Level1 EQ-5000 convective warming system is a Class II imported medical body surface warming device. The complete system consists of convective warming host, 2.1m air delivery hose and SW series single-use sterile convective warming blanket. Adopting forced hot air convection warming technology, it is equipped with dual-channel independent safety temperature control loops and four levels of standardized hot air output (ambient air / 36℃ / 40℃ / 44℃) with temperature control accuracy ±1℃. It rapidly blocks radiative and convective skin heat loss of patients, prevents and treats perioperative hypothermia, and reduces clinical complications including shivering, surgical site infection, coagulation disorders and delayed anesthesia recovery. The device is applicable to full clinical departments including operating room, PACU, ICU, emergency department, neonatology and dialysis unit, covering all high hypothermia risk populations such as adults, elderly, infants, traumatic shock patients and severe infection patients. Use is absolutely prohibited in cases with ischemic non-perfused tissue, broken skin wounds, complete loss of skin sensation and environments with flammable anesthetic gas. Caution is required with full-time dedicated monitoring for patients with severe heart failure, coagulation disorders, extremely low birth weight neonates and patients receiving long-term vasoconstrictor drugs. Warming blankets are single-use sterile consumables for one patient only, reuse is forbidden. Operation shall only be performed by professional medical staff; regular monitoring of patient skin and core temperature is required during surgery to avoid painless scald risks. Equipment storage requires a light-proof, dry and dust-free environment with temperature 5~40℃ and relative humidity 5%~95%, kept far from corrosive reagents and high-frequency electromagnetic equipment. Idle equipment shall be powered on weekly for moisture removal maintenance. Contact official after-sales service for equipment fault maintenance; self-disassembly is prohibited. The complete system features low operating noise, 0.2µm high-efficiency air filtration and self-locking air-leak-proof pipelines, with multiple safety protections including power-on self-test, over-temperature power-off and audio-visual alarm for pipeline occlusion. Compliant with IEC safety standards for medical warming devices, it serves as standardized clinical equipment for perioperative temperature management.


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