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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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100% found this document useful (1 vote)
129 views

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.

Uploaded by

Arrigo Prieto
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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


notice. All rights reserved by COMEN

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