Radiofrequency

 Indications for Use

The NT2000iX™ generator is intended for lesioning neural tissue. The NT2000iX™ generator is intended to be used for pain management. The NT2000iX™ generator is to be used only with separately cleared/approved lesion/temperature probes (NeuroTherm™ radiofrequency probes and SPINECATH™ and ACUTHERM™ catheters). The NT2000iX™ generator is indicated for use in the peripheral nervous system.

 Warnings

•Read the Instructions for Use before operating the NT2000iX™ RF generator.

•HAZARDOUS ELECTRICAL OUTPUT – The equipment is for use only by qualified medical personnel.

•ELECTRIC SHOCK HAZARD – Do not under any circumstances perform any testing or maintenance on the equipment while it is being used on a patient.

•FIRE HAZARD – DO NOT use extension cords or adapters of any type. The power cord and plug must be intact and undamaged.

•ELECTRIC SHOCK HAZARD – A failure of the equipment could result in unintended increase of output power. If unexpected readings of parameters are observed that do not correspond to the preset values, the procedure should be halted immediately by pressing the STOP button on the front panel. Do not operate the equipment again until a determination of the source of the problem has been identified and corrected.

•ELECTRIC SHOCK HAZARD – Should the power cord or plug become cracked, frayed, broken, or otherwise damaged, it must be replaced immediately.

•ELECTRIC SHOCK HAZARD – Unplug the power cord before cleaning or service.

•ELECTRIC SHOCK HAZARD – The operator should not perform any servicing of the equipment. Any servicing should only be carried out by qualified personnel.

•EXPLOSION HAZARD – This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

•ELECTRIC SHOCK HAZARD – Always turn the equipment off before cleaning and do not allow any fluid to enter the ventilation holes or sockets.

•ELECTRIC SHOCK HAZARD – Do not touch any exposed wiring or conductive surface while cover is off and the equipment is energized. The voltage present when the electric power is connected to the equipment can cause injury or death. Never wear a grounding wrist strap when working on energized equipment.

•ELECTRIC SHOCK HAZARD – Do not remove the top cover of the NT2000iX™ RF generator, as it will expose voltage which can cause injury or death.

•FIRE HAZARD – Use non-flammable agents for cleaning and disinfection wherever possible.

•FIRE HAZARD – Flammable agents for cleaning, disinfecting, or as solvents of adhesives shall be allowed to evaporate before application of RF surgery.

•POOLING HAZARD – There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina.

•POOLING HAZARD – Fluids pooled in the body depressions and cavities should be mopped up before the NT2000iX™ RF generator is used.

•IGNITION HAZARD – Attention is called to the danger of ignition of endogenous gasses (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the NT2000iX™ RF generator).

•FUSE REPLACEMENT – For continued protection against fire hazard, replace only with same type and rating of fuse as displayed on the rear Serial Number Plate.

•RISK OF RF BURNS TO PATIENT – Ensure patient does not come into contact with metal parts of the table and its accessories – antistatic sheeting is recommended.

•RISK OF RF BURNS TO PATIENT – Avoid skin-to-skin contact between different parts of patient’s body (for example between the arms and the body of the patient) – use dry gauze if necessary.

•RISK OF RF BURNS TO PATIENT – Avoid using physiological monitoring equipment during a procedure – if monitoring is required, monitoring electrodes should be placed as far as possible from the NeuroTherm™ cannula. Monitoring devices which use needle electrodes are not recommended.

•RISK OF RF BURNS TO PATIENT – Position all cables to the NeuroTherm™ cannula and grounding pad (also known as dispersive pad or reference pad) in such a way to avoid contact with the patient or other leads.

•RISK OF RF BURNS TO PATIENT – Place temporarily unused electrodes connected to the generator in a container or area that is electrically isolated from the patient. Never place a generator-connected electrode that is not being used in contact with the patient.

•RISK OF RF BURNS TO PATIENT – If unexpected readings of parameters are observed that do not correspond to the preset values, the procedure should be halted immediately by pressing the STOP button on the front panel. Do not operate the equipment again until a determination of the source of the problem has been identified and corrected.

•RISK OF RF BURNS TO PATIENT – If patient is sedated, place your hand on the backside of the grounding pad, while still leaving it attached to the patient, and STOP the procedure if the grounding pad gets unreasonably hot (a temperature greater than 46°C).

•RISK OF RF BURNS TO PATIENT – When positioning grounding pad, select a well-vascularized muscular site with proximity to the procedure.

•RISK OF RF BURNS TO PATIENT – Only use grounding pads listed in the Accessories (page 1).

•RISK OF RF BURNS TO PATIENT – Entire area of grounding pad should be reliably attached to a suitably prepared and appropriate area of the patient’s body as defined by the Grounding Pad IFU.

•INTERFERENCE WITH ACTIVE INPLANTS – Check whether the patient has a cardiac pacemaker or other active implant. A possible hazard exists because interference with the action of the pacemaker may occur or the pacemaker may be damaged. In case of doubt, obtain qualified advice.

INTERFERENCE WITH OTHER EQUIPMENT – During RF lesioning procedures, the radiated electrical fields may interfere with other electrical medical equipment. (See Minimizing Electromagnetic Interference (page 10).)

•RISK OF PATIENT INJURY – DO NOT USE ENDOSCOPICALLY- The accessories are not appropriate for endoscopic use.

•RISK OF RF BURNS TO PATIENT – In Manual Lesion Mode, select the lowest possible power for intended purpose.

•RISK OF RF BURNS TO PATIENT – Check the grounding pad before applying power to the patient.

•RISK OF RF BURNS TO PATIENT – If patient complains of heating at the grounding pad, stop the procedure and remove the grounding pad from patient.

•PROBES – Use only NeuroTherm™, SPINCATH™, or ACUTHERM™ probes or other probes cleared/approved by NeuroTherm listed in Accessories (page 1).

•Data log only can hold a certain number of files. Check log number before using to make sure no previous data will be over written.

 Cautions

CAUTION indicates a condition that may lead to equipment damage or malfunction.

•Do not activate the output of the NT2000iX™ RF generator until the probe is properly positioned in the patient.

•GENERAL CONSIDERATIONS – Regularly inspect the accessories of the generator. In particular, electrode cables should be checked for possible damage to the insulation.

•GENERAL CONSIDERATIONS – If the equipment has in any way suffered mechanical damage, it should be returned to the supplier for inspection and test before further use.

•IMPROPER LINE VOLTAGE – The voltage selector on the mains input socket is factory-set and should not be changed by the user. The serial number plate shows the correct mains input voltage for the machine and the rating of the fuses to be used in the mains input unit fuse holder. An incorrect voltage setting may result in generator malfunction and potential damage.

•USE OF FLUIDS – Ensure that, if fluids (saline etc.) are being used during a procedure, they are positioned away from the generator.

•DISPERSIVE CONNECTIONS – In monopolar applications, ensure that the grounding or return electrode is connected to the patient and to the Generator.

•CLEANING – When cleaning the outer casing touch panel or screen of the equipment; do not use abrasive agents or solvents.

•CONNECTION OF EQUIPMENT TO REAR OF MACHINE – Any equipment connected to the rear socket must comply with IEC 60950 and IEC 60601-1.

•EMERGENCY STOP – For safety, always have someone positioned next to the STOP button during operation. If at any time the device is behaving erratically, press the red STOP button, which will return the device to a safe state. An example would include if the displayed temperature and graph do not match the desired set temperature