ES-300D/ES-300 New Generation Intelligent Electrosurgical Generator

Intended Use
The High Frequency Surgical Equipment is intended for tissue cutting and/or coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

Contraindications
Patients for whom electrosurgery could have a negative effect on the state of the patient.
Patients with implanted electronic devices (e.g. pacemakers or cardiovascular-defibrillators)
Patients with a weakened immune system
Patients with blood coagulation disorders.

Cautions & Warnings
Unqualified medical staff are not allowed to use this Electrosurgical Generator – may cause electric shock and burns to patients and staff.
Patients with implantable cardiac pacemakers or other metal implants are at risk, as the device may interfere with or even damage the pacemaker. If in doubt, appropriate and effective advice should be given.
Danger of fire and explosion from flammable organic solvents and solutions (e.g., medical alcohol, tincture), oxygen-enriched environments, and oxidants.
Generator failures may lead to unexpected increase in output power – in case of failure, stop using the equipment.
Auxiliary equipment and surgical accessories shall have a rated voltage ≥ the maximum output voltage of the generator.
Check interfaces and wires of accessories in advance to ensure they are intact and in good condition.
Return electrodes compatible with the REM system are recommended to ensure sound and light alerting signals are available when safe contact is lost.
Choose the lowest possible output power for the desired effect.
This equipment must be connected to a power source with protective grounding to avoid electric shock.
Activated electrodes are prohibited from contacting any metal objects – may cause serious surgical risks.
Activated electrodes must not get close to combustible materials – may cause fire.
Activated electrodes not in use should be placed in a protective sheath or a clean, dry, non‑conductive location, away from combustible materials and patient contact.
If electrosurgery is performed on the posterior area of the chest, flammable anesthetics and oxidizing gases (e.g., N₂O, oxygen) are prohibited unless removed before operation.
If output power is significantly reduced or the equipment does not function normally, the return electrode may have application failure or poor contact.
It is not allowed to mute the volume of the equipment – may result in failure to notice accidental start‑up or REM error information.
Skin‑to‑skin contact between doctors and patients should be avoided – use insulating gloves and insert dry gauze if necessary.
Neuromuscular stimulation can lead to risks, especially in the case of electric arcs between the active electrode and tissue.
Monitoring electrodes should be kept as far as possible from the high‑frequency electrode. Needle‑shaped monitoring electrodes are not recommended.
After surgery, turn off the power switch and unplug the power plug before cleaning the equipment.
For reusable accessories, pay attention to cleaning, disinfection, packaging, sterilization methods, and reuse limitations – strictly follow instructions.
Do not disassemble the device without permission – may lead to electric shock.
Portable and mobile RF communication equipment will affect the operation of medical electrical equipment.
The equipment should not be used adjacent to or stacked with other equipment. If unavoidable, observe the equipment to verify normal operation.

Residual Risks
Patients with implantable cardiac pacemakers or other metal implants are at risk – interference or damage to the pacemaker may occur.
Activated electrodes near combustible materials may cause fire.
Tissue fumes and aerosols may have carcinogenic and infectious health problems.
The equipment may cause radio interference or may interrupt the operation of nearby equipment.