PRECAUTION：

1.The WJTY procedure should be performed by physicians trained in the procedureand the use of the WJTY-RFA-490 Rotational Ablation Denervation Device. 

2.The WJTY-RFA-490 device is exclusively designed for use with the WJTY Rotational Ablation Denervation handpiece. Do not connect any other items to the device.

3.Users should be familiar with the operation of the WJTY-RFA-490 device prior to the use of this product and observe all warnings and precautions noted throughout these instructions and in the WJTY Rotational Ablation Denervation Device IFU. 

4.The Effect Level should be set as low as possible to achieve the desired treatment effect. Failure to do so may result in patient complications or incomplete treatment.

Do not use any component that has been damaged as injury may occur.

Do not stack equipment on top of the WJTY-RFA-490 device or place the device on to of electrical equipment. These configurations are unstable and/or do not allow adequate cooling. 

5.The activated electrosurgical device can interfere with the function of other electronic equipment. Provide as much distance as possible between the electrosurgical WJTY-RFA-490 device and other electronic equipment (such as monitors). 

6.Nonfunction of the WJTY-RFA-490 device may cause interruption of surgery. A backup device should be available for use. 

7.Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active.

8.To avoid the possibility of a burn to the patient, when using a split pad do not activate the unit if the solid pad indicator is illuminated green or the red alarm indicator remains illuminated red. This could indicate improper pad placement or a faulty NEM (contact quality monitor) circuit.

9.When activating the unit, do not allow direct skin contact between the patient and the physician. 

10.Remove any loose fitting jewelry from the patient before activation.

11.Examine all accessories and connections to the WJTY-RFA-490 device before use. Ensure that the accessories function as intended. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects. 

12.When not using WJTY Rotational Ablation Denervation handpiece, place them in a holster or in a clean, dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns.

13.Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means. 

NOTICES: 

1.If required by local codes, connect the device to the hospital equalization connector with an equipotential cable.

2.Connect the power cord to a wall outlet having the correct voltage. Otherwise, product damage may result.

WARNING： 

1.This device to use by, or on order of a physician.

2.Hazardous Electrical Output - This equipment produces potentially hazardous electrical output and must only be used by trained, licensed physicians.

3.To avoid incompatibility and unsafe operation, use suitable cables, accessories, and neutral electrodes, including values for the highest allowed high frequency peak voltage.

4.Fire / Explosion Hazard - Do not modify this equipment. Modifications may result in increased risk of electrical, fire, and explosion. Do not use the device in thepresence of flammable anesthetics. The following substances will contribute to  increased fire and explosion hazards in the operating room: 

?Flammable substances (such as alcohol based skin prep agents) 

?Naturally occurring flammable gases which may accumulate in body cavities such as the bowel. 

?Oxygen enriched atmospheres 

?Oxidizing agents (such as nitrous oxide (N2O) atmospheres). 

5.The sparking and heating associated with the electrosurgical procedures can provide an ignition source. Observe fire precautions at all times. When using the device in the same room with any of these substances or gasses, prevent their accumulation or poolingunder surgical drapes, or within the area where the procedure is performed. 

6.The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away. 

7.Non-flammable agents should be used for cleaning and disinfection wherever possible.

8.Flammable cleaning agents should be allowed to evaporate before the use of the device. There is a risk of pooling flammable solutions under the patient or in body depressions and body cavities. Any fluids pooled in these areas should be mopped up before the device is used. Attention should be called to the danger ofignition of endogenous gasses. Some materials, for example cotton and gauze, may be ignited by sparks when saturated by oxygen. 

9.Electric Shock Hazard - Always turn off and unplug the WJTY-RFA-490 device before cleaning. 

10.Do not use power plug adapters or extension cords. 

11.This equipment must only be connected to a supply mains with protective earth to avoid the risk of electric shock. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed onthe back of the unit.

12.The entire area of the NEUTRAL ELECTRODE should be reliably attached to a suitably prepared and appropriate area of the PATIENT'S body as defined by the MANUFACTURER. The patient should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth (for example operating table supports, etc.).  Failure of the WJTY-RFA-490 device could result in an unintended increase of output power. Use the lowest effect level necessary for the patient’s BMI. Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury. The higher the current flow, and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small structures. Apparent low output or failure of the HF SURGICAL EQUIPMENT to function correctly at the normal operating settings may indicate faulty application of the NEUTRAL ELECTRODE or poor contact in its connections. In this case, the application of the NEUTRAL ELECTRODE and its connections should be checked before selecting a higher output power. 

13.Associated equipment and accessories used must be rated to withstand the combination of the Vpeak rating and Crest Factor. Associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 350 Vpeak max. 

14.Use electrosurgery with caution in the presence of internal or external devices such as pacemakers or pulse devices. Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the device manufacturer or hospitalCardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices. 

15.If the patient has an Implantable Cardioverter Defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical procedure.Electrosurgery may cause multiple activation of ICDs.

16.When the device and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. In all cases, monitoring systems incorporating high frequency current limiting devices are recommended. Needle monitoring electrodes are not recommended, as inadvertent electrosurgical burns may result.

17.To reduce the potential for alternate site burns, do one or more of the following: 

?Avoid skin-to-skin contact points, such as fingers touching leg, when positioning the patient. 

?Place 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that contact does not occur. 

?Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin-to-skin contact areas. 

?In addition, place patient return electrodes according to the manufacturer’s instructions.            

18.Do not touch the active accessory. A burn could result. 

19.Potential for alternate site burns increases if the return electrode is compromised. Use of split patient return electrodes and devices with a contact quality monitoring system are recommended.

20.Unless a compatible monitoring NE (neutral electrode) is used with a contact quality monitor, loss of safe contact between the NE and the patient will not result in an auditory alarm.

21.Use of accessories 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. Portable RF communications (including peripherals such as antenna cables and external  antennas) should be used no closer than 30 cm (12 inches) to any part of the WJTY-RFA-490  including cables specified by WJTY . Otherwise, degradation of the performance of  WJTY-RFA-490 could result.  The device is equipped with a return electrode sensing and contact quality monitoring system (NEM), which monitors the quality of thepatient return electrode connection. When a correctly functioning single plate return electrode is connected to the device, the NEM verifies the connections between the device and the single return electrode. It DOES NOT verify that a single return electrode is in contact with the patient. When using a split return electrode, the NEM confirms the total resistance is within the preset safety range. Proper appliction (such as hydrating the patient’s skin) and visual inspection of the patient return electrode is required for safe operation.

22.Do not wrap the accessory cords or patient return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.

23.The patient leads should be positioned in such a way that contact with the PATIENT or other leads is avoided.

24.Minor neuromuscular stimulation is possible when arcs between the active electrode and tissue occur. The device has been designed to minimize the possibility of neuromuscular stimulation.