厂家直供戴维婴儿T-组合复苏器NEO-Ⅰ
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厂家直供戴维婴儿T-组合复苏器NEO-Ⅰ
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
NEO-Ⅰ
结构及组成/主要组成成分
产品由压力表、阀门总成(含进气口、出气口、最大安全压力设置阀以及吸气峰压设置阀)、最大安全压力设置阀保护盖帽和外壳组成。
适用范围/预期用途
预期用于医疗机构产房、婴儿病房和新生儿重症监护室、为体重不超过10kg的婴儿提供复苏抢救，是一台人工操作、气体驱动的复苏装置。
产品储存条件及有效期
1. 工作原理 Working Principle
中文本设备为气体驱动、手动触发式 T‑型正压通气装置，无需外接电源。压缩空 / 氧气源以恒定流量进入主机阀组；分别设置吸气峰压 PIP、呼气末正压 PEEP、最大安全压力 Pmax。常态下持续输出 PEEP 维持肺泡功能残气量；操作者手动按压复苏按钮，叠加预设吸气峰压完成一次正压吸气；松开按钮自动回到 PEEP 呼气状态；安全阀限制最高输出压力，避免肺气压伤；压力表实时监测回路压力，可接面罩或气管导管实施复苏通气。
EnglishThis is a gas‑driven, manually triggered T‑piece positive‑pressure ventilation device without power supply. Compressed air/oxygen source flows into valve assembly at constant flow. Operators set Peak Inspiratory Pressure(PIP), Positive End‑Expiratory Pressure(PEEP) and maximum safety pressure(Pmax). Continuous PEEP is delivered to maintain functional residual capacity(FRC) at standby. Manually press resuscitation button to deliver preset PIP for positive‑pressure inspiration; release button to return to PEEP expiration. Safety valve limits peak pressure to prevent barotrauma. Manometer monitors circuit pressure in real‑time. It can work with face mask or endotracheal tube for resuscitation。
2. 产品功能 Functions
中文
为体重≤10kg 婴儿提供可控正压通气复苏；
输出稳定可调吸气峰压 PIP；
输出稳定可调呼气末正压 PEEP，维持肺泡开放；
最大安全压力 Pmax 超限保护，防止压力过高损伤；
压力表实时显示气道压力；
兼容面罩、气管插管两种复苏通路；
气源氧浓度 21%‑100%，适配产房、NICU、转运急救场景。
English
Deliver controlled positive‑pressure ventilation resuscitation for infants ≤10 kg body weight;
Provide stable and adjustable Peak Inspiratory Pressure(PIP);
Provide stable and adjustable Positive End‑Expiratory Pressure(PEEP) to keep alveoli open;
Over‑pressure protection via adjustable maximum safety pressure(Pmax) to avoid lung injury;
Built‑in manometer for real‑time airway pressure monitoring;
Compatible with resuscitation face mask and endotracheal intubation;
Support oxygen concentration 21%‑100% from gas source, suitable for delivery room, NICU and emergency transport。
3. 产品特点 Product Features
中文
纯气动无电源，停电、转运场景均可使用；
PIP、PEEP、Pmax 独立可调，输出压力稳定，相比球囊减少压力波动；
高精度压力表，量程‑10~80 cmH₂O，精度 ±2% 满刻度，直观读取气道压；
符合 ILCOR、NRP 新生儿复苏指南，适合早产儿复苏，保护功能残气量；
T‑型单手操作，降低医务人员操作疲劳；
整机轻巧，含附件总重≤2 kg，便于转运急救；
设置 Pmax 安全阀，防止意外高压肺损伤；
适配气源流量 5‑15 L/min，氧浓度跟随外接气源 21‑100%；
配置模拟肺用于术前测试校验系统压力。
English
Pneumatic design without power supply, available for power‑failure and patient transport;
Independently adjustable PIP, PEEP and Pmax; stable pressure output with less fluctuation than self‑inflating bag;
High‑precision manometer, range‑10~80 cmH₂O, accuracy ±2% full scale for direct airway pressure reading;
Compliant with ILCOR & NRP resuscitation guidelines; preserves functional residual capacity especially for preterm infants;
One‑hand T‑piece operation reduces operator fatigue;
Light‑weight unit, total mass ≤2 kg with accessories, easy for emergency transport;
Adjustable Pmax safety valve against accidental high‑pressure lung injury;
Gas source flow range 5‑15 L/min; oxygen concentration 21‑100% depends on inlet gas supply;
Test lung included for pre‑use pressure system verification。
4. 技术参数 Technical Specifications
表格
| 中文 | English |
|---|---|
| 适用对象：体重≤10 kg 婴儿 | Applicable patient: Infants ≤10 kg body weight |
| 整机尺寸：190 mm (W)×100 mm (D)×263 mm (H) | Dimensions:190 mm(W)×100 mm(D)×263 mm(H) |
| 总质量（含附件）：≤2 kg | Total mass(with accessories): ≤2 kg |
| 气源输入流量：5‑15 L/min | Inlet gas flow:5‑15 L/min |
| 输出氧浓度：21‑100%（取决于外接气源） | Output O₂ concentration: 21‑100% (dependent on source gas) |
| 压力表量程：‑10～80 cmH₂O；精度 ±2% FS | Manometer range:‑10～80 cmH₂O; Accuracy ±2% full scale |
| 安全压力 Pmax：1‑60 cmH₂O；出厂默认 40 cmH₂O | Max safety pressure(Pmax):1‑60 cmH₂O; factory default 40 cmH₂O |
| 吸气峰压 PIP：随输入流量可调；5L/min：1‑57 cmH₂O；8L/min：2‑58 cmH₂O；10L/min：3‑59 cmH₂O；15L/min：5‑60 cmH₂O | Peak Inspiratory Pressure(PIP): flow‑dependent adjustment;5L/min:1‑57 cmH₂O;8L/min:2‑58 cmH₂O;10L/min:3‑59 cmH₂O;15L/min:5‑60 cmH₂O |
| 呼气末正压 PEEP：随输入流量可调；8L/min：0.2‑17 cmH₂O；10L/min：0.5‑23 cmH₂O；15L/min：1‑28 cmH₂O | PEEP setting range: flow‑dependent;8L/min:0.2‑17 cmH₂O;10L/min:0.5‑23 cmH₂O;15L/min:1‑28 cmH₂O |
| 工作环境温度：‑18℃～+50℃；湿度≤95% 无冷凝 | Operating ambient:‑18℃～+50℃; humidity ≤95% non‑condensing |
| 储存运输：‑40℃～+60℃；湿度≤95%；气压 50‑106 kPa | Storage & transport:‑40℃～+60℃; humidity ≤95%; atmospheric pressure 50‑106 kPa |
5. 使用方法 Operating Procedure
中文
术前检查：主机、管路、T‑接头、面罩 / 气管导管完好无破损；连接模拟肺，进行整机压力校验；
气源连接：接入压缩空氧混合气源，调节气源流量至 5‑15 L/min；
参数预设置：按患儿体重，设置Pmax 安全压力→PEEP 呼气末正压→PIP 吸气峰压；
患者连接：T 接头接婴儿面罩或气管插管，保证回路密闭；
通气操作：单手操作 T‑件，持续维持 PEEP；按压复苏按钮输出 PIP 进行吸气；松开按钮回到 PEEP 呼气；观察胸廓起伏，同步参考压力表读数，控制通气频率；
临床评估：评估心率、胸廓、血氧，按需调整压力参数；
结束使用：关闭气源，拆卸管路，按规范清洁消毒主机与可复用部件，一次性耗材废弃处理；
转运使用时保证气源充足。
English
Pre‑use inspection: Check main unit, tubing, T‑piece, mask/ET tube for damage. Connect test lung to verify pressure perｆormance.
Gas supply connection: Connect compressed air‑oxygen source, set inlet flow to 5‑15 L/min.
Preset parameters: Adjust Pmax safety pressure → PEEP → PIP according to infant weight.
Patient connection: Attach T‑piece to infant face mask or endotracheal tube, ensure circuit tightness.
Ventilation operation: Single‑hand control of T‑piece. Maintain baseline PEEP. Press resuscitation button to deliver PIP for inspiration; release for PEEP expiration. Observe chest rise and manometer reading to control ventilation rate.
Clinical assessment: Evaluate heart rate, chest movement and SpO₂; adjust pressures as required.
Post‑use procedure: Shut gas supply, disconnect circuit. Clean and disinfect reusable components per protocol; discard single‑use accessories.
Ensure adequate gas supply during patient transport.
6. 适应症 Indications
中文医疗机构产房、婴儿病房、新生儿重症监护室，用于体重不超过 10 kg 婴儿（含早产儿）窒息、呼吸抑制时的正压通气复苏抢救，可面罩通气或气管插管下复苏通气。
EnglishFor positive‑pressure resuscitation ventilation of infants (including preterm infants) ≤10 kg with asphyxia or respiratory depression in delivery room, infant ward and NICU; usable with face‑mask or endotracheal intubation resuscitation。
7. 禁忌症 Contraindications
原厂说明书无绝对禁忌症，下列临床情形不适合单纯 T‑piece 面罩复苏，需优先外科 / 其他处置。
中文
存在气道完全梗阻，无法建立有效气道通气；
严重胸壁缺损、膈疝等先天性畸形，面罩正压通气会加重病情；
气胸未引流，正压通气会加剧胸腔压力恶化。
提示：本设备仅做通气复苏，不能解决解剖性气道畸形，需配合气道管理与其他抢救手段。
EnglishNo absolute contraindications per IFU. Conditions below are not suitable for simple T‑piece mask resuscitation and require priority surgical/interventional management.
Complete airway obstruction where effective ventilation cannot be established;
Severe congenital anomalies e.g. diaphragmatic hernia, chest‑wall defect, in which mask positive‑pressure ventilation may worsen clinical status;
Undrained pneumothorax; positive pressure may aggravate intrathoracic pressure. Note: This device provides ventilation only; anatomical airway anomalies require additional airway management.
8. 注意事项 Precautions
中文
经培训的医护人员操作，严格遵循新生儿复苏指南；
使用前必须使用模拟肺校验整套系统压力输出是否准确；
优先设置 Pmax 安全限压，防止意外高压致肺气压伤；
气源流量必须维持 5‑15 L/min，压力输出随流量变化，流量偏离会造成 PIP、PEEP 不准；
压力表读数为回路压力，临床同时观察胸廓起伏，不能仅依赖表值；
一次性管路、面罩不可重复使用；可复用部件按说明书做清洁消毒，不可高温高压灭菌主机；
主机为气动装置，严禁液体进入阀体内部；
不能用于长期机械通气，复苏抢救短时使用；
转运前确认气源余量充足；
定期维护校验压力表，保证压力精度；
若压力异常、漏气，立刻停止使用，排查管路接头；
本设备无氧浓度调节模块，氧浓度完全由外接空氧混合仪控制。
English
To be operated only by trained medical personnel following neonatal resuscitation guidelines.
Always verify system pressure output with test‑lung before clinical use.
Always set Pmax over‑pressure limit first to prevent barotrauma.
Maintain inlet gas flow 5‑15 L/min. PIP / PEEP perｆormance is flow‑dependent; out‑of‑range flow will cause inaccurate pressure.
Manometer reflects circuit pressure; always observe chest rise, do not rely solely on gauge reading.
Single‑use tubing and mask are for one‑time use only. Clean & disinfect reusable accessories per IFU; do NOT autoclave main unit.
Prevent liquid ingress into internal valve assembly.
For short‑term resuscitation only, NOT for prolonged mechanical ventilation.
Confirm sufficient gas reserve before transport.
Periodically calibrate manometer for pressure accuracy.
Stop immediately in case of abnormal pressure or leak; inspect tubing and connectors.
NEO‑Ⅰ has no built‑in oxygen blender; inspired oxygen concentration is fully controlled by external gas mixer.
9. 储存条件 Storage Conditions
中文储存、运输环境温度：‑40 ℃～+60 ℃；相对湿度≤95%（无冷凝）；大气压力 50‑106 kPa；放置于干燥通风，避免阳光直射、粉尘、腐蚀性气体环境；远离撞击振动。
EnglishStorage & transport ambient: Temperature‑40 ℃～+60 ℃; relative humidity ≤95% non‑condensing; atmospheric pressure 50‑106 kPa. Store in dry and ventilated place; avoid direct sunlight, dust, corrosive gas, heavy shock and vibration。
10. 说明书核心摘要 IFU Core Summary
中文戴维 NEO‑Ⅰ 婴儿 T‑组合复苏器为二类气体驱动手动 T 型复苏装置，无需电源，用于≤10kg 婴儿窒息复苏；可独立调节 PIP、PEEP、Pmax 安全压力，压力表实时监测气道压力；依靠外接气源 5‑15L/min 工作，氧浓度跟随外接气源 21‑100%；只用于短时复苏抢救，不可作为长期呼吸机；使用前模拟肺校验压力；操作者必须经过新生儿复苏培训；一次性耗材禁止复用；主机禁止高压蒸汽灭菌；储存宽温，适合产房、NICU、转运急救。临床必须以原厂纸质 IFU 作为执行依据。
EnglishDAVID NEO‑Ⅰ Infant T‑Piece Resuscitator is Class‑II gas‑driven manual resuscitator without power supply, for resuscitation of infants ≤10 kg suffering from asphyxia. Independently adjustable PIP, PEEP and Pmax safety limit; built‑in manometer for real‑time airway pressure monitoring. Operates with external gas source flow 5‑15 L/min; inspired oxygen 21‑100% depends on external supply. Intended for short‑term resuscitation only, NOT for prolonged ventilation. Perｆorm pre‑use pressure validation with test lung. Operators must receive ｆormal neonatal resuscitation training. Single‑use accessories shall not be reused. Main unit must not be autoclaved. Wide‑range storage temperature, suitable for delivery room, NICU and patient transport. Clinical operation must strictly follow original manufacturer printed IFU.
免责提示：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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