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HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The device is a prescription use (Rx) device.

HPR45i is a monopolar electrosurgical electrode intended to remove tissue and control bleeding using radio frequency electrical current. It is a prescription use device which is intended to be used by a licensed doctors or specialist in the healthcare facility/ hospital. The HPR45i is supplied sterile (Sterilized by EO Sterilization) and is not intended to be reused. It consists of 3 different parts such as HPR45i handle, output cable and stainless-steel tube. The stainless-steel tube is insulated over most of its exposed length, and it is connected to the stainless steel (AISI316L) tip at the end. The material of insulation is PTFE. The stainless steel (AISI316L) tip and PTFE insulation are the direct patient contacting parts of the device. It is an external communicating device with limited duration (<24hrs) of contact with tissue and blood. The HPR45i is designed to be used in combination with a radiofrequency generator (MedRF4000 (K210077) manufactured by F Care Systems USA LLC) for the application of haemostasis of soft tissue. The RF signal, which is generated by the generator, passes through the HPR45i, and is applied on the soft tissue by means of the HPR45i tip. When contact is made with tissue, the RF signal is converted into heat resulting in the bleeding to stop and haemostasis to appear. The HPR45i has no power regulating function, and it does not contain a diagnostic or monitoring function.

THE MED RF 4000 SYSTEM IS INTENDED FOR THE EPILATION AND FOR THE TREATMENT OF LOWER LIMB SPIDER VEIN OR TELANGECTASIA BY THERMOCOAGULATION.

The MedRF4000 consists of the following parts: The generator, The pedal, The output cable, The neutral electrode cable (optional), The needle holder. The following consumables can be used with the MedRF4000: The Ballet needles, The neutral electrode (optional).