This document provides specifications for the B8 neonatal incubator made by Shenzhen Comen Medical Instruments Co., Ltd. Key features include temperature, humidity, and oxygen control, as well as monitoring capabilities like ECG, respiration rate, blood oxygen saturation, and non-invasive blood pressure. Safety standards include ISO 13485 certification and compliance with European Medical Device Directives. Physical characteristics include a touch screen display and dimensions of approximately 1130mm by 680mm by 1600mm.
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B8 Specifications V2.2 2022.08.12
This document provides specifications for the B8 neonatal incubator made by Shenzhen Comen Medical Instruments Co., Ltd. Key features include temperature, humidity, and oxygen control, as well as monitoring capabilities like ECG, respiration rate, blood oxygen saturation, and non-invasive blood pressure. Safety standards include ISO 13485 certification and compliance with European Medical Device Directives. Physical characteristics include a touch screen display and dimensions of approximately 1130mm by 680mm by 1600mm.
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Specifications: B8
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD
Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106,P.R. China Tel: +86-755-26408879 Fax: +86-755-26431232 Email: [email protected] Web: www.comen.com
2022V 2.2 Neonatal Incubator B8
Standard Configuration: 95% with 0.3um particle, 99.9% with
Humidity Control, Temp (skin temperature& incubator air 0.5um particle temperature), Recorder, tray, Height adjustment, Damping CO2 concentration 0.1% doors (Double-layered), Masimo SpO2, 3-lead ECG, RESP, Operation Environment Comen NIBP, HR Working Temp 20~30°C Optional Configuration: Humidity 10% to 95% (noncondensing) Weight Scale, EtCO2, 5-lead ECG, Nellcor SpO2, O2 Air flow: ≤0.3m/s concentration monitoring, Apnea monitoring, Apnea Power Supply 100-240V~, 50/60Hz±1Hz awaking, Servo oxygen supply Battery Type Rechargeable Lithium-ion battery Safety Standards Battery Capacity 4400mAh ISO 13485:2003 approved, MDD 93/42/EEC as amended by Battery Recharging MDD 2007/47/EC Time Maximum 6 hours for charging; Physical Characteristics Battery backup 2 hours for continuous working (such Size: 1130mm×680mm×1600mm functions as heating, humidifying Weight: 93kg and lifting shall be excluded) Mattress size: 622mm×396mm×20mm Indicator: Mattress tray load: 10kg One alarm indicator Side panel: 761mm*325mm Power indicator Access door: 212mm*175mm Battery indicator Screen Size: 12.1” TFT touch screen QRS beep and alarm sound Resolution: 800 × 600 Operating key sound Hood (Canopy) 763mm×490mm×350mm Interface: Dimensions: (1287mm from the ground) Parameter cable interface Mattress height 893mm AC power input Water Tank Three auxiliary power output Capacity: ≥1L Plug-in slot Lifting system: Available USB port Tray and bracket: Optional RJ45 port X-ray tray: Available Date storage: Humidifier: Available Alarm Review: 200 groups Damping Doors: Available Wave Review: ≥24 min (single wave) Drawer: Dual-layer compartmentalized NIBP Review: 2000 groups drawer Trend Graph: 120 hours Caster wheel four brakes Trend Table: 120 hours Filter efficiency Power-off Yes Input frequency 50/60 Hz storage: Auxiliary output supply Alarm: User-adjustable High and Low 3-level Output voltage 220~240 V~ Limits; Output frequency 50/60 Hz Prioritized audible and visual alarm Output current 0.9A Recorder: Oxygen Servo-Controller Type: Built-in; thermal array Setting range: 21~60% Channel: 2 channel waveforms Measurement Speed: 25mm/s,50mm/s range: 10~100% Record width 50mm Accuracy: ±2% Temperature Control O2 supply pressure: 0.27~0.7MPa Setting range: 35.0~37.5°C (Infant mode) O2 Concentration Available 25.0~39.0°C (Air Mode) Calibration Set temperature exceeds 37°C, Weight Scale should press the display the "> 37°C" Measurement key, and then confirmed by the Range: 300g~8000g interface pop-up window to enter Resolution: 1g Measurement Accuracy: ±10g range: 25.0~45.0°C Trend View: 7days Resolution: 0.1°C ECG: Accuracy: ±0.3°C Lead Type: CardioTecTM5-leads ECG Analysis, 3- Alarm range: 34~38.5°C (Infant mode), ±0.5 or leads selectable ±1°C of the set value Lead selection 5-lead: I; II; III; aVR; aVL; aVF; V 23~41°C (Air Mode), ±1 or ±2°C of 3-lead: I; II; III the set value Gain Selection X0.25, X0.5, X1, X2, Auto Heating time: ≤35mins (Temperature inside the Sweep Speed: 6.25,12.5, 25, 50mm/s thermostat cover rises by 11°C) Heart Rate Range: 15-350bpm Humidification Resolution: 1 bpm time: <20mins (In indoor environment to Protection: Withstand 4000VAC/50Hz voltage in 25°C±2°C, relative humidity of isolation; 40%±10% conditions, reach to 36°C, Against electrosurgical interference relative humidity of 85%) and defibrillation; Operation without Accuracy: ±1% or ±1bpm (whichever is greater) adding water time: ≥12 hours Bandwidth: MON Mode:0.5 Hz~40 Hz Humidity Control DIA Mode: 0.05Hz~130 Hz Relative humidity OPE Mode:1 Hz~20 Hz range: 30%~95% ST Mode:0.2Hz~40Hz Resolution: 1% ST detection: -2.0mV - +2.0 mV (Automatic) Accuracy: ±5% (Set humidity less than 85%); Resolution: 0.01mV ±10% (Set humidity over than 85%) Accuracy: -0.8mV ~ +0.8mV: ±0.02mV or ±10% Features whichever is greater; Air flow rate inside Others: Unspecified thermostat cover: ≤0.1m/s Arrhythmia Work mode: Air/ Infant analysis: Available Bed tilt range: -10° ~ +10° Respiration: Input voltage 220 V~ Method: RA-LL Impedance Method Input current 6.6 A RR measurement Measurement & range: 6~150rpm alarm range 1~100% Accuracy: ±1rpm Resolution: 1% Resolution: 1 rpm Accuracy: ±3% (70-100%, non-motion) RESP Apnea 10s-30s 1-69% unspecified Alarm: Audible and visual alarm; alarm PR Measurement events reviewable Range: 25~240bpm Sweep Speed: 6.5,12.5mm/s Resolution 1bpm Gain Selection: X0.25, X0.5, X1, X2, X4 Accuracy: ±3bpm(non-motion) NIBP: ±5bpm(motion) Method Automatic Oscillometric Alarm Range: 20-350bpm Work mode: Manual / Automatic PI value: 0.02~20% Measurement time: Adjustable(1-480min) Resolution: 0.01% (0.02%~9.99%) Measurement Unit: mmHg / kPa selectable 0.1% (10.0%~20.0%) Measurement Accuracy: unspecified types: Systolic, Diastolic, Mean Nellcor SpO2: Range of systolic Measurement pressure: 40-135mmHg range 0-100% Range of diastolic Resolution: 1% pressure: 10-100mmHg Accuracy: ±3% (70-100%, non-motion) Range of mean 0-69% unspecified pressure: 20-110mmHg Alarm range: 20-100% Over-pressure PR Measurement protection: Both hardware and software Range: 20-300bpm over pressure protection Resolution: 1bpm Accuracy: Less than ±3mmHg Accuracy: ±3bpm (20-250bpm); Resolution: 1mmHg Unspecified (251-300bpm) Alarm: Systolic, Diastolic, Mean Alarm Range: 20-350bpm PR from NIBP: 40-240bpm Respironics EtCO2 (Sidestream) Resolution: 1bpm Measurement Accuracy: ±3% or ±3bpm, whichever is greater & alarm range: 0-150 mmHg, 0– 19.7kPa (at ComenSpO2: 760mmHg) Measurement Accuracy: ± 2 mmHg (0 – 40 mmHg) & alarm range 0~100% ± 5% of reading (41 – 70 mmHg) Resolution: 1% ± 8% of reading (71 –100 mmHg) Accuracy: ±3% (70-100%, non-motion) ± 10% of reading (101 –150 mmHg) Unspecified (0-69%) awRR range: 2-150rpm PR measure awRR accuracy: ±1rpm Range: 25-254bpm Response time: <240msec (10% to 90%) Resolution: 1bpm Delay time: <2s Accuracy: ±1bpm Respironics EtCO2(mainstream) Alarm Range: 0-300bpm Measurement PI value: 0.02~20% & alarm range: 0-150 mmHg, 0 –20kPa (at Resolution: 0.01% (0.02%~9.99%) 760mmHg) 0.1% (10.0%~20.0%) Accuracy: ±2mmHg (0 – 40 mmHg) Accuracy: unspecified ±5% of reading (41 – 70 mmHg) Masimo SpO2: ±8% of reading (71 –100 mmHg) ±10% of reading (101 –150 mmHg) Delay time: <2s awRR range: 0-150rpm Masimo EtCO2 (mainstream) awRR accuracy: ±1rpm Measurement Response time: <240msec (10% to 90%) & alarm range: 0-190 mmHg, 0–25% (at 760mmHg) Delay time: <2s Accuracy: 0~114 mmHg: ± (2.25mmHg + 4% of Masimo EtCO2 (Sidestream) reading);114~190 mmHg: Measurement unspecified & alarm range: 0 -190 mmHg, 0– 25% (at 760mmHg) AwRR range: 0-150rpm Accuracy: 0~114 mmHg: ± (2.25mmHg + 4% of AwRR accuracy ±1rpm reading);114~190 mmHg: Response time: <240msec (10% to 90%) unspecified Delay time: <2s AwRR range: 0-150rpm AwRR accuracy: ±1rpm Response time: <240msec (10% to 90%)
*Notice: Specifications subject to changes without prior