It is characterized in that the device does not contact the wound, and the washing of different parts is selected by the operator according to the clinical needs. Different flow rates and different liquid flow shapes may be selected. A clear operative vision can be obtained, and the incidence of surgical infection can be reduced; Bone chips, blood clots and fat particles can be removed sufficiently to reduce the incidence of death due to embolism.
The product is tested by quality supervision and inspection center, and the performance reaches the standard requirements. The product is clinical trial in domestic famous hospitals, such as Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Affiliated Hospital of Anhui Medical University and other domestic famous hospitals. The clinical report shows that the overall performance reaches the level of similar foreign products.
It is characterized in that the device does not contact the wound, and the washing of different parts is selected by the operator according to the clinical needs. Different flow rates and different liquid flow shapes may be selected. A clear operative vision can be obtained, and the incidence of surgical infection can be reduced; Bone chips, blood clots and fat particles can be removed sufficiently to reduce the incidence of death due to embolism.
The product is tested by quality supervision and inspection center, and the performance reaches the standard requirements. The product is clinical trial in domestic famous hospitals, such as Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Affiliated Hospital of Anhui Medical University and other domestic famous hospitals. The clinical report shows that the overall performance reaches the level of similar foreign products.
It can effectively prevent infection, inflammation, and reduce wound healing and the like. It is applicable to orthopedics, thoracoabdominal surgery, emergency, gynaecology and so on. And is particularly suitable for cleaning various complex cavities and wall surfaces. The device is characterized in that the device can form a pulse water flow, and the pressure can be adjusted according to the needs, and meanwhile as automatic washing, the device can attract the sewage, reduce the pollution and create a clear view.
Operating principle: the motor drives the gear to rotate, and the pulse pressure is formed in the piston cavity. Different input power of the motor produces different water pressure, and the flow rate can reach 780ml/min. With different spray heads, different shapes of water flow can be ejected, and can be used for cleaning different parts.
Can be used for orthopedics: when the joint surgery is performed, the fat particles adhered on the cancellous bone can be removed completely through high-pressure washing, and the fat embolism after operation is reduced. In the total hip or semi-hip replacement surgery of bone cement, the effect of bone trabecula filling in bone cement was increased. Reduces the early loosening of the bone cement fixation prosthesis. Can be used for emergency debridement, can eliminate wound dirt, reduce the occurrence of granuloma, shorten the debridement time and improve the operation efficiency. Can be used for thoracoabdominal surgery, gynaecology, urology and microsurgery, can create a clear field of view in the operation, reduce the visual fatigue of the doctor and improve the operation efficiency. At the same time, the residue after surgery was reduced, and the operation was reduced and issued.
Clinical benefit: The device can perform its intended function in order to remove debris and reduce infection rate (achieved with saline solution).
Safety information:
GENERAL WARNINGS!
1.Sterile only if Package is unopened and undamaged. Do not use if the package is damaged.
2.Explosion Hazard.
3.Do not use in presence of flammable anesthetics or gases.
4.Do not submerge handle in liquid as this may compromise the efficiency of the pump or alter the PH of the liquid.
5.Operating environment limits:5-40℃,Less than 80% RH,86-106.6kPa.
6.Transport and storage environment limit :-10-40℃, less than 80% RH,86-106kPa.
7.The size of the double row pipe connected with the collection container: inner diameter φ6.5±0.2mm, outer diameter φ9.45±0.2mm, length 2.8±0.02m
8.The device is not suitable for use in an MRI environment.
9.Operation Mode:Non-continuous operation;Maximum Activation time:2min;Minimum Deactivation time:1min.
10.Do not apply to patients weighing less than 11kg.
WARNING!
1.Warning statement that addresses the HAZARDS that can result from unauthorized modification of the ME EQUIPMENT
2.This device can only be sold on Order by the Physician .
3.Short-term contact (60min-30days) in accordance with Annex VIII Classification Rule.
4.Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.
5.Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
6.Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
7.Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the model WJ-06, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
NOTE:
1.Disposable. Do not reuse as it may lead to cross infection,surgical site infection and the device failure which will affect the debridement effect and serious medical safety risks.
2.Store in cool and dry place.
3.Contents : 1 Piece
4.If the device is stored for more than one year, we recommend you to check the battery.
5.Only doctors and nurses should use the device. Read the instructions carefully before use.
6.Sterile only if package is unopened and undamaged.
7. During use, the operator only needs to turn off the power switch to terminate the operation of the device.
8 The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
9. Do not use mobile phones or other devices that emit electromagnetic fields near this equipment. Electromagnetic interference generated during the use of this equipment may have harmful effects on nearby equipment. In such cases, users can adopt the following methods:
a) Adjust the direction or position of the interfered equipment
b) Increase the distance between the device and the interfered device
c) This device uses a separate internal power supply
d) Contact the manufacturer or technical service provider
10. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
