FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
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Product Highlights
- Comprehensive Monitoring: Supports ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP, and optional IBP/CO2.
- FDA & CE Certified: FDA-approved with CE and ISO13485 certifications for home and hospital use.
- Advanced ECG Analysis: Features arrhythmia, ST-segment analysis, and pacemaker detection with 5-lead options.
- Flexible NIBP Modes: Supports Manual, AUTO, and STAT modes with intervals from 1 to 960 minutes.
- Safety & Reliability: Class I, type CF defibrillation-proof applied part with audible/visual alarms.
- Data Storage & Output: Includes trend data storage, output capabilities, and alarm event marking.
- Versatile Power Supply: Operates on 100-240V~, 50/60Hz, suitable for global hospital and home environments.
Product Attributes
- Customization
- Available
- Classification
- Physiological Functions of Diagnosis and Monitoring Equipment
- Type
- ECG
- Model NO.
- CMS8000
- Certification
- CE, ISO13485
- Group
- Middle-aged and Old
- Transport Package
- Carton
- Specification
- 43.1*35.3*42.5(cm)
- Trademark
- kindsway
- Origin
- China
- HS Code
- 9018193010
- Production Capacity
- 500/Week
Product Images of FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
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Product Description
Functions
Standard parameters: ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP
1)ECG Heart rate(HR)
ECG waveform
Arrhythmia and ST-segment analysis
2)RESP Respiration rate(RR)
Respiration waveform
3)SpO2 Oxygen saturation(SpO2)
Plethysmogram(PLETH) waveform
Pulse rate(PR)
Bar graph
4)NIBP Systolic pressure(SYS), Diastolic pressure(DIA), Mean pressure(MEAN)
5)TEMP T1, T2, TD
6)IBP(optional) CH1:SYS,DIA,MAP
CH2:SYS,DIA,MAP
IBP waveform
7)CO2(optional) EtCO2
InsCO2:Inspired Minimum CO2
AwRR:Air Way Respiration
It has abundant functions, such as audible and visual alarm, trend data storage and output, NIBP
measurement, alarm event marking and drug concentration calculation, etc.
Performance
| ECG | Multi-parameter Portable Cardiac Patient Monitor FDA |
| Lead selection: I, II, III, aVR, aVL, aVF, V | |
| Waveform: 5-lead, dual-channel | |
| 3-lead, single-channel | |
| Gain: 2.5mm/mV, 5.0mm/mV, 10mm/mV, 20mm/mV, 40mm/mV | |
| Scan speed: 12.5mm/s, 25 mm/s, 50 mm/s | |
| HR: | Measurement and alarm range: 15~350 bpm |
| Accuracy: ±1 % or ±1 bpm, whichever is greater | |
| Alarm accuracy: ± 2 bpm | |
| Resolution: 1 bpm | |
| ST-segment monitoring: | |
| Measurement and alarm range: -2.0 mV ~ +2.0 mV | |
| Accuracy: -0.8 mV~+0.8 mV ±0.04 mV or ±10%, whichever is greater | |
| Other range: unspecified | |
| Arrhythmia analysis: ASYSTOLE, VFIB/VTAC, COUPLET, BIGEMINY, TRIGEMINY, R ON T, VT>2, | |
| PVC, TACHY, BRADY, MISSED BEATS, PNP, PNC | |
| Pacemaker: yes | |
| RESP | Method: R-F(RA-LL) Impedance |
| Respiration rate:Measurement and alarm range: 0~150 rpm | |
| Resolution: 1 rpm | |
| Measurement accuracy: ±2 rpm | |
| Alarm accuracy: ±3 rpm | |
| Apnea alarm: 10~40s | |
| Scan speed: 6.25 mm/s, 12.5 mm/s, 25 mm/s | |
| NIBP | Method: Oscillometry |
| Mode: Manual/AUTO/STAT | |
| Measurement interval in AUTO mode: 1/2/3/4/5/10/15/30/60/90/120/240/480/960 minutes | |
| Measurement period in STAT mode: 5 minutes | |
| Measurement and alarm range: 10 ~ 270 mmHg | |
| Resolution: 1 mmHg | |
| Cuff pressure accuracy: ±3 mmHg | |
| Measurement accuracy: Maximal mean deviation: ±5 mmHg Maximal standard deviation: 8 mmHg |
|
| Over-pressure protection: Adult mode: 297±3 mmHg Pediatric mode: 240±3 mmHg Neonatal mode: 147±3 mmHg |
|
| Spo2 | Measurement and alarm range: 0 ~ 100% |
| Resolution: 1% | |
| Measurement accuracy: 70%~100%: ±2%; | |
| 0%~69%: unspecified | |
| PR | Measurement and alarm range: 30 ~ 250 bpm |
| Measurement accuracy: ±2 bpm or ±2%, whichever is greater | |
| TEMP | Channel: dual-channel |
| Measurement and alarm range: 0 ~ 50ºC | |
| Resolution: 0.1 ºC | |
| Accuracy: ±0.1 ºC | |
| EtCO2 | Method: Sidestream or Mainstream Measuring Range: 0~150mmHg |
| Resolution:0~69 mmHg, 0.1 mmHg 70~150 mmHg, 0.25 mmHg |
|
| Accuracy:0~40 mm Hg ±2 mm Hg 41~70 mm Hg ±5% 71~100 mm Hg ±8% 101~150 mm Hg ±10% |
|
| AwRR Range: 2~150 rpm | |
| AwRR Accuracy: ±1BPM | |
| Apnea Alarm: Yes | |
| IBP | Channel: dual-channel |
| Label: ART, PA, CVP, RAP, LAP, ICP, P1, P2 | |
| Measuring and Alarm Range: -10~300 mmHg | |
| Resolution 1 mmHg | |
| Accuracy: ±2% or 1mmHg, whichever is greater | |
| Power supply: 100-240V~, 50/60Hz | |
| Safety classification: Class I, type CF defibrillation-proof applied part |



About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR244057". Items marked "" are certified.
Company Profile
Yangzhou Kindsway Biotech Co., Ltd. Was established in 2011, the main business of medical products, Focus on to provide our clients with quality products and services, the company since its inception, with the vast number of customers to establish a good business relationship, at present, the company is in accordance with the modern enterprise system in operation, build up the company set research and development, production management, domestic and foreign trade as one of the modern enterprise group currently forward.
Our company offers variety of products which can meet your multifarious demands. We adhere to the management principles of "quality first, customer first and credit-based" since the establishment of the company and always do our best to satisfy potential needs of our customers. Our company is sincerely willing to cooperate with enterprises from all over the world in order to realize a win-win situation since the trend of economic globalization has developed with anirresistible force.
About Our Factory & Business Background
- Address
- 198# North Shuangxian Road Xiannv Town Jiangdu District, Yangzhou
- Terms of Payment
- T/T, Western Union
- International Commercial Terms(Incoterms)
- FOB, CIF, EXW
- Average Lead Time
-
Peak Season Lead Time: within 15 workdays
Off Season Lead Time: within 15 workdays - Nearest Port
- Shanghai
Our Production Capability & Technical Expertise
- Main Products
- Ventilator, X-ray, Ultrasound, C-Arm, Slippers, Dr System, Cr System, Test Kit, Medical Equipment, Ambulance
Our Industry Experience & Global Business Record
- Export Year
- 2011-09-27
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
FAQ
- What monitoring parameters does the CMS8000 support?
- It supports ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP, and optional IBP and CO2 monitoring.
- Is this device suitable for home use?
- Yes, it is FDA-approved and designed for both home and hospital use.
- What certifications does the monitor have?
- The device holds FDA, CE, and ISO13485 certifications.
- Can the NIBP measurement be automated?
- Yes, it supports Manual, AUTO, and STAT modes with adjustable intervals in AUTO mode.
- What are the ECG lead options available?
- It supports 5-lead, dual-channel 3-lead, and single-channel configurations.
- Does the device have alarm functions?
- Yes, it features audible and visual alarms for various parameters and alarm events.
- What is the power supply requirement?
- It requires 100-240V~, 50/60Hz power supply.
- Is data storage and output supported?
- Yes, it includes trend data storage, output capabilities, and alarm event marking.
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