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Provide Medical Device Consulting and Regulatory Requirements Compliance Services

for ISO 13485, CE Mark and FDA Compliance for Medical Devices.

A GMP specialist will full medical device manufacturing and quality management expertise.  

DESCRIPTION : FLUID WARMER QW3
 
Clinical  application:
·Blood transfusion / infusion for the patients during operation or after operation;
· Routine blood transfusion / infusion in the clinical setting;
·Intravenous nutrition or nasal feeding;
·Children and neonates’ infusion ;
·Normal infusion in cold seasons;
Technology of control:
Microcomputer system provides high precise control , permanently running self-tests , and malfunction alarm
Temperature monitoring:
Numerical display for real-time temperature or setting temperature
Accuracy: ±0.5 ℃
Temperature setting: 33 ℃ ~ 42 ℃ ( adjustable at rate of 0.1℃)
High temperature cut-off: Setting temperature+1℃/ 43℃/48±3℃
Low temperature alarm: Setting temperature-1℃
Uses Normal Transfusion / Infusion Tubing
Recommeded flow rate : 0-16ml/min
 
TECHNICAL  DATA
Model:                                                          QW-518S
Power supply:                                                AC220V±10%/50~60Hz
Power consumption :                                      Max.70VA
Type of protection against electric shock:          class I
Degree of protection against electric shock:       type B
Degree of protection against ingress of liquids:    IP×4 splash proof
Warming time:                                               ≈1min
Operating mode:                                            Continuous
Dimensions :                                                  180×70×45mm
Net Weight:                                                  0.61kg

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993