Hospital Clinical Infant Incubator with CE (H-800)
医院临床婴儿孵化器CE（H-800）
| 型号。 | H-800 |
| 证明 | CE |
| 组 | 婴儿 |
| 医疗器械注册/记录号 | Gsyjxz20123540587 |
| 升温时间 | ≤30min30min0min |
| 温度均匀性 | ≤1°CE; 1℃g;ce;1°c |
| 商标 | Healicom |
| 起源 | 中国 |
| 类型 | 婴儿孵化器 |
| 液晶显示器 | 无液晶显示 |
| 医疗器械监管类型 | 类型2 |
| 温度控制模式 | 空气控制 |
| 温度变化 | ±0.5°csmn; 0.5℃g;csmn;0.5°c |
| 气温 | 20℃〜37℃立方厘米〜37℃下g;cc~37°c |
| 规范 | 异 |
| HS编码 | 90189090 |
标准成分：
伺服控制模式：空气温度
2.即时参数显示：设定温度，空气温度，热功率;
3.听觉和视觉报警：电源故障，传感器故障，更高/更低的温度，空气温度超驰，风扇故障;诱惑;lure;
4.断电复位记忆和自检功能;
5.双坡口：4个手动口
规范：
伺服控制模式：空气温度
2.即时参数显示：设定温度，空气温度，热功率;
3.听觉和视觉报警：电源故障，传感器故障，更高/更低的温度，空气温度超驰，风扇故障;诱惑;lure;
4.断电复位记忆和自检功能;
5.双坡口：4个手动口
规范：
| 功率 | 型号H-800-1E | 110 / 120V交流，50Hz / 60Hz | |||
| 型号H-800-2E | 220 / 240V交流，50Hz / 60Hz | ||||
| 电源输入 | ≤400va00va00VA | ||||
| 参见IEC60601-1，本设备属于ClassI，BF型 其运行持续 | |||||
| 报警 | 电力报警 | 电源故障：如果孵化器的主电源出现故障或电源线与墙壁插座意外断开，请激活 | |||
| 风扇报警 | 风扇故障：风扇电机故障时激活 | ||||
| 传感器报警 | 空气传感器故障：空气传感器故障，请参考使用单位 | ||||
| 偏差报警 | 高气温：如果显示空气温度高于设定点15°Cpoint | ||||
| 低气温：如果显示空气温度比设定点低25°Cpoint | |||||
| 过温报警 | 过热温度：显示时空气温度在空气模式模式下接近38°C Mode | ||||
| 系统报警 | 系统故障：温度控制系统故障时激活 | ||||
| 温度控制范围和相关规格 | 气温 | 20℃〜37℃〜37℃下eg;C~37°C | |||
| 升温时间 | ≤30min0min0min | ||||
| 温度变化 | ±0.5°CMN; 0.5℃eg;Cmn;0.5°C | ||||
| 温度均匀性 | ≤1℃; 1℃eg;C;1°C | ||||
| 环境要求 | 环境温度 | 工作温度范围 | + 20℃〜+ 30℃+ 30℃eg;C+30°C | ||
| 存储温度范围 | -40℃〜+ 55℃+ 55℃eg;C+55°C | ||||
| 环境湿度 | 工作湿度范围 | 30%~75% | |||
| 商店湿度范围 | 10%~100% | ||||
| 大气压力范围 | 700hPa〜1060hPa | ||||
| 其他 产品规格 | 敞篷环境噪声水平 | ≤55dB（环境噪声低于45dB）5dB）5dB) | |||
| 敞篷中的二氧化碳（CO2）水平 | 当空气中的二氧化碳混合物以750ml / min的速度在床垫中心10cm处递送时，小于0.5％ | ||||
| 床垫空气速度 | 小于0.3m / s | ||||
| 婴儿床最大负荷 | 10公斤 | ||||
| 输血架最大载荷 | 2公斤 | ||||
| 出厂默认设置 | 温度控制模式空气温度模式 | ||||
| 空气温度：32°C; Cdeg;C | |||||
| 温度单位：℃C; Cdeg;C | |||||
| Model NO. | H-800 |
| Certification | CE |
| Group | Infant |
| Medical Devices Reg./Record No. | Gsyjxz20123540587 |
| Temperature Rise Time | ≤30min30min0min |
| Temperature Uniformity | ≤1°ce;1°cg;ce;1°c |
| Trademark | Healicom |
| Origin | China |
| Type | Infant Incubator |
| LCD Display | Without LCD Display |
| Medical Device Regulatory Type | Type 2 |
| Temperature Control Mode | Air Control |
| Temperature Variability | ±0.5°csmn;0.5°cg;csmn;0.5°c |
| Air Temperature | 20°c~37°cc~37°cg;cc~37°c |
| Specification | ISO |
| HS Code | 90189090 |
Standard Composition:
1. Servo Control Mode: air temp;
2. Instant Parameter Displaying: set temp, air temp, heat power rate;
3. Audible & Visual Alarms: power failure, sensor failure, higher/lower temp, air temperature override, fan failure;lure;lure;
4. Power failure reset memory and self-test function;
5. Hood with dual slope: 4 hand-ports
Specification:
1. Servo Control Mode: air temp;
2. Instant Parameter Displaying: set temp, air temp, heat power rate;
3. Audible & Visual Alarms: power failure, sensor failure, higher/lower temp, air temperature override, fan failure;lure;lure;
4. Power failure reset memory and self-test function;
5. Hood with dual slope: 4 hand-ports
Specification:
| Power | Model H-800-1E | 110 / 120 V ac, 50Hz / 60Hz | |||
| Model H-800-2E | 220 / 240 V ac, 50Hz / 60Hz | ||||
| Power Input | ≤400VA00VA00VA | ||||
| Refer to IEC60601-1, this equipment belongs to ClassI, Type BF Its operation is continuous | |||||
| Alarm | Power Alarm | Power Failure: Activates if primary power to the Incubator fails or the power wire is accidentally disconnected from the wall receptacle | |||
| Fan Alarm | Fan Failure: Activates if Fan motor malfunctions | ||||
| Sensor Alarm | Air Sensor Failure: Air Sensor malfunction, refer unit to service | ||||
| Deviation Alarm | High Air Temperature: Activated if displayed Air Temperature is 15°C above set pointpointpoint | ||||
| Low Air Temperature: Activated if displayed Air Temperature is 25°C below set pointpointpoint | |||||
| Over Temperature Alarm | Over Air Temperature: Activated when displayed Air Temperature was approach 38°C in Air Mode Mode Mode | ||||
| System Alarm | System Failure: Activated if Temperature Control System malfunctions | ||||
| Temperature Control Range and Correlative Specifications | Air Temperature | 20°C~37°C~37°Ceg;C~37°C | |||
| Temperature Rise Time | ≤30min0min0min | ||||
| Temperature Variability | ±0.5°Cmn;0.5°Ceg;Cmn;0.5°C | ||||
| Temperature Uniformity | ≤1°C;1°Ceg;C;1°C | ||||
| Environment Requirement | Environment Temperature | Operation Temperature Range | +20°C~+30°C+30°Ceg;C+30°C | ||
| Store Temperature Range | -40°C~+55°C+55°Ceg;C+55°C | ||||
| Environment Humidity | Operation Humidity Range | 30%~75% | |||
| Store Humidity Range | 10%~100% | ||||
| Atmospheric Pressure Range | 700hPa~1060hPa | ||||
| Other Specifications | Noise Level Within Hood Environment | ≤55dB(Environment noise below 45dB)5dB)5dB) | |||
| Carbon Dioxide (CO2) Level within the Hood | Less than 0.5% when a mixture of CO2 in air is delivered at 750ml/min at a point 10cm above the center of the mattress | ||||
| Air Velocity Over Mattress | less than 0.3m/s | ||||
| Infant Bed Max Load | 10kg | ||||
| Transfusion Shelf Max Load | 2kg | ||||
| Factory Default Settings | Temperature Control Mode Air Temperature Mode | ||||
| Air Set Temperature: 32°Cdeg;Cdeg;C | |||||
| Temperature Units:°Cdeg;Cdeg;C | |||||
