CE Approved Medical Equipment High Grade Infant Incubator (H-2000)
CE认证医疗设备高档婴儿保育箱（H-2000）
| 型号。 | H-2000 |
| 证明 | ce，iso13485 |
| 组 | 婴儿/新生儿 |
| 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 |
| 证书 | ce，iso |
| 关键词 | 婴儿孵化器 |
| 运输包装 | 纸板箱 |
| 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 | 空气和皮肤伺服控制 |
| 温度变化 | ±0.5°csmn; 0.5℃g;csmn;0.5°c |
| 皮肤传感器精度 | ≤0.3°C0.3℃下g;c0.3°c |
| 保证 | 12个月 |
| 商标 | Healicom |
| 规范 | 异 |
| HS编码 | 90189090 |
标准成分：
1.伺服控制模式：空气温度，皮肤温度;
2.即时参数显示：设定温度，空气温度，皮肤温度，加热器功率;
3.听觉和视觉报警：电源故障，传感器故障，更高和更低的温度，空气和皮肤温度超驰，风扇故障，系统故障;阀杆故障;stem failure;
4.> 37°C预设模式：电源故障复位存储器，报警静音，键盘锁定，自检功能;tion;
5.双坡口：6个手口;左右机柜，上架;舵;helf;
6. RS-232输出连接器（用于网络系统）
规范：
注意： 打开检修面板或检修门，或使用孵化器内的用品或其他设备，可改变气流模式，可能会影响温度均匀性，温度变化，培养箱温度读数与中心床垫温度和皮肤温度的相关性
1.伺服控制模式：空气温度，皮肤温度;
2.即时参数显示：设定温度，空气温度，皮肤温度，加热器功率;
3.听觉和视觉报警：电源故障，传感器故障，更高和更低的温度，空气和皮肤温度超驰，风扇故障，系统故障;阀杆故障;stem failure;
4.> 37°C预设模式：电源故障复位存储器，报警静音，键盘锁定，自检功能;tion;
5.双坡口：6个手口;左右机柜，上架;舵;helf;
6. RS-232输出连接器（用于网络系统）
规范：
| 功率 | 型号H-2000-1E | 110 / 120V交流，50Hz / 60Hz | |||
| 型号H-2000-2E | 220 / 240V交流，50Hz / 60Hz | ||||
| 电源输入 | ≤400va00va00VA | ||||
| 参见IEC60601-1，本设备属于ClassI，BF型 其操作是连续的 | |||||
| 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 | ||||
| 传感器不在位置：当传感器不在正确的位置执行校准或继续操作时激活 | |||||
| 皮肤传感器断开：当皮肤传感器与温度控制器断开连接时，在皮肤控制模式下激活 | |||||
| 皮肤传感器故障：皮肤传感器故障时激活 | |||||
| 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 | |||||
| 高皮肤温度：显示时激活皮肤温度高于设定点10°Cpoint | |||||
| 低皮肤温度：如果显示皮肤温度比设定点低10°Cpoint | |||||
| 过温报警 | 过热温度：显示时空气温度接近38°C，设定温度≤37°C，空气模式下设定温度> 37°C时，空气温度接近40°C;空气模式下空气温度37°Cegt;37°C in Air Mode | ||||
| 超过皮肤温度：显示时激活皮肤温度接近38°C设定温度≤37°C，或接近39°C设置温度> 37°C在皮肤模式中; 37°C在皮肤模式et;37°C in Skin 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°C〜37°C，设定温度≤37°C，37°C〜39°C，设定温度> 37°Cor设定温度> 37°Ceg;Cor set temperature >37°C | |||
| 皮肤温度 | 20°C〜37°C，设定温度≤37°C，37°C〜38°C，设定温度> 37°Cor设定温度> 37°Ceg;Cor set temperature >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 | ||||
| 皮肤传感器精度 | ≤0.3°C.3℃下eg;C.3°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 | ||||
| 机柜最大负载 | 6公斤 | ||||
| “SILENCE”KeyE功能t; Key | 按此键使闹钟静音10分钟 | 偏差报警 | |||
| 传感器报警 | |||||
| 风扇报警 | |||||
| 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 | |||||
| 皮肤套装温度：34°C; Cdeg;C | |||||
| 温度单位：°Cdeg; Cdeg;C | |||||
注意： 打开检修面板或检修门，或使用孵化器内的用品或其他设备，可改变气流模式，可能会影响温度均匀性，温度变化，培养箱温度读数与中心床垫温度和皮肤温度的相关性
| Model NO. | H-2000 |
| Certification | CE, ISO13485 |
| Group | Infant / Neonate |
| Medical Devices Reg./Record No. | Gsyjxz20123540587 |
| Temperature Rise Time | ≤30min30min0min |
| Temperature Uniformity | ≤1°ce;1°cg;ce;1°c |
| Certificate | CE, ISO |
| Keyword | Infant Incubator |
| Transport Package | Carton |
| Origin | China |
| Type | Infant Incubator |
| LCD Display | Without LCD Display |
| Medical Device Regulatory Type | Type 2 |
| Temperature Control Mode | Air and Skin Servo Control |
| Temperature Variability | ±0.5°csmn;0.5°cg;csmn;0.5°c |
| Skin Sensor Precision | ≤0.3°c0.3°cg;c0.3°c |
| Warranty | 12 Months |
| Trademark | Healicom |
| Specification | ISO |
| HS Code | 90189090 |
Standard Composition:
1. Servo Control Mode: air temp, skin temp;
2. Instant Parameter Displaying: set temp, air temp ,skin temp, heater power rate;
3. Audible & Visual Alarms: power failure, sensor failure, higher & lower temp, air& skin temp override, fan failure, system failure;stem failure;stem failure;
4. ﹥37°C Preset Mode: power failure reset memory, alarm silence, keypad lock, self-test function;unction;tion;
5. Hood with dual slope: 6 hand-ports; left & right cabinets, top-shelf;helf;helf;
6. RS-232 Output Connector (Use for network system)
Specification:
NOTE: Open Access Panel or Access Door or the use of supplies or other equipment within the Incubator, which can alter the air flow pattern, may effect temperature uniformity, temperature variability, the correlation of the Incubator temperature reading to center mattress temperature and skin temperature
1. Servo Control Mode: air temp, skin temp;
2. Instant Parameter Displaying: set temp, air temp ,skin temp, heater power rate;
3. Audible & Visual Alarms: power failure, sensor failure, higher & lower temp, air& skin temp override, fan failure, system failure;stem failure;stem failure;
4. ﹥37°C Preset Mode: power failure reset memory, alarm silence, keypad lock, self-test function;unction;tion;
5. Hood with dual slope: 6 hand-ports; left & right cabinets, top-shelf;helf;helf;
6. RS-232 Output Connector (Use for network system)
Specification:
| Power | Model H-2000-1E | 110 / 120 V ac, 50Hz / 60Hz | |||
| Model H-2000-2E | 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 | ||||
| Sensor Out of Position: Activated when Sensor is not in correct position to perform calibration or continue operation | |||||
| Skin Sensor Disconnected: Activated during Skin Control Mode when Skin Sensor is disconnected from Temperature Controller | |||||
| Skin Sensor Failure: Activated when Skin Sensor malfunctions | |||||
| 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 | |||||
| High Skin Temperature: Activated if displayed Skin Temperature is 10°C above set pointpointpoint | |||||
| Low Skin Temperature: Activated if displayed Skin Temperature is 10°C below set pointpointpoint | |||||
| Over Temperature Alarm | Over Air Temperature: Activated when displayed Air Temperature was approach 38°C for set temperature ≤37°C, or approach 40°C for set temperature ﹥37°C in Air Modegt;37°C in Air Modeegt;37°C in Air Mode | ||||
| Over Skin Temperature: Activated when displayed Skin Temperature was approach 38°C for set temperature ≤37°C, or approach 39°C for set temperature ﹥37°C in Skin Modet;37°C in Skin Modeet;37°C in Skin Mode | |||||
| System Alarm | System Failure: Activated if Temperature Control System malfunctions | ||||
| Temperature Control Range and Correlative Specifications | Air Temperature | 20°C~37°C,for set temperature ≤37°C, 37°C~39°C, for set temperature ﹥37°Cor set temperature >37°Ceg;Cor set temperature >37°C | |||
| Skin Temperature | 20°C~37°C,for set temperature ≤37°C, 37°C~38°C, for set temperature ﹥37°Cor set temperature >37°Ceg;Cor set temperature >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 | ||||
| Skin Sensor Precision | ≤0.3°C.3°Ceg;C.3°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 | ||||
| Cabinet Max Load | 6kg | ||||
| Function of 'SILENCE' KeyE" Keyt; Key | Make the alarm to be silence for 10 minutes by press this key | Deviation Alarm | |||
| Sensor Alarm | |||||
| Fan Alarm | |||||
| Factory Default Settings | Temperature Control Mode Air Temperature Mode | ||||
| Air Set Temperature: 32°Cdeg;Cdeg;C | |||||
| Skin Set Temperature: 34°Cdeg;Cdeg;C | |||||
| Temperature Units:°Cdeg;Cdeg;C | |||||
NOTE: Open Access Panel or Access Door or the use of supplies or other equipment within the Incubator, which can alter the air flow pattern, may effect temperature uniformity, temperature variability, the correlation of the Incubator temperature reading to center mattress temperature and skin temperature
