Indications, safety and warnings for CEDAR™ Radiofrequency Ablation System

The Endovenous Radiofrequency Generator is used with radiofrequency catheters intended for vessel coagulation.

Patients with thrombus in the vein segment to be treated.

Note: Please read all instructions thoroughly before using the RF system, including the instructions for the Cedar Endovenous Radiofrequency Catheters. Please comply with all warnings, precautions and cautions specified in the full text of the instructions for use, otherwise complications may occur in patients.

To ensure device security and warranty validity:

• Do not tamper with tamper-evident label.
• Intentional damage to or removal of the label will void the product warranty.
• If the label is damaged accidentally, contact the Boston Scientific Customer Service immediately to document the case—warranty remains valid with proper verification.

Setting up the generator
Electric shock hazard

• Do not use 3-to-2-prong converter plug.
• Always use 110~230 V single-phase AC power.
• The generator must only be connected to a power supply with protective earth.
• Do not remove the cover of the generator.

Fire and explosion hazard

• Do not operate the generator in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
• Do not operate the generator in contact with flammable materials, chemicals, or substances.
• Do not place active instruments near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.
• Prevent pooling of flammable fluids and the accumulation of flammable or oxidizing gases or vapors under surgical drapes or near the surgical site. These fluids should be removed before using electrosurgery.
• Use of electrosurgery may create arcing or embers that pose a fire hazard, especially in oxygen enriched environments. Keep the device clean and free of all debris.
• The generator's performance may be affected by the use of portable and mobile communications equipment operating in near proximity. Refer to "Electromagnetic Interference (EMI)" for more information.

During RF treatment

Use the generator only with the Cedar Endovenous Radiofrequency Catheters. Do not use catheters from any other manufacturer with the generator as this may increase emissions, decrease immunity to interference, or injure the patient or user.

Be alert for potential interference with pacemakers and other active implants. In case of doubt, approved qualified advice should be obtained.

When the generator is activated, the conducted and radiated electrical fields might interfere with other medical electrical equipment. Refer to "Electromagnetic Interference (EMI)" for more information.

To prevent patient injury, always check if the measured temperature and RF power shown in the data display area are within safe operating ranges.

To avoid electric shock, while using the RF generator, do not allow the patient to come into direct contact with grounded metal objects.

To avoid electric shock, avoid contact of catheters and cables with the patient, leads, or other equipment.

Do not wrap the catheter cable around metal objects, as this might induce hazardous currents into the patient.

The generator requires special precautions regarding Electromagnetic Compatibility and needs to be set up and put into service according to "Electromagnetic Compatibility (EMC)".

Generator failure could result in an unintended increase in RF output.

Use of electrosurgical products could result in neuromuscular stimulation resulting in patient injury.

Starting RF treatment

If RF treatment does not stop, disconnect the catheter to prevent injury to the patient.

The RF status icon changes from gray to green to indicate Ready to Treat again, and the timer resets to 20 seconds. Cumulative treatment time appears in the lower left area of the screen:

1. If additional treatment is needed,
   a. Reposition the catheter (and/or adjust compression) for the next RF treatment
   b. Press the catheter handle button to start the next RF treatment
2. Repeat step 3 until the procedure is completed.

General description and operating conditions

Do not operate the generator in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Do not operate the generator in contact with flammable materials, chemicals, or substances.

• The RF generator should be used with only attached power cord and plugged into only grounded hospital-grade AC sources.
• Plastic Enclosure. Service Port is for factory use only.
• Isolated Patient Connections include heating device and thermocouple.
• The generator cannot be sterilized and must not enter a sterile surgical field.
• The display has touch screen, with no protective plastic cover.
• The display backlight operates with 11 VDC at 150 mA.
• USB devices are typically plastic of unknown insulation properties and are operator-inaccessible when the generator is powered.
• Activation time CedarTM catheter: 20 seconds (fixed)

Service & maintenance

The generator contains no operator-serviceable parts. The generator must be returned to the factory for service. No modification of this device is allowed.

Do not remove the cover of the generator, as there is a potential for electrical shock.

Electromagnetic compatibility (EMC)

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.

The 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.

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 this product, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

If the use location is near (e.g. less than 1.5 km from) AM, FM or TV broadcast antennas, before using this equipment, it should be observed to verify that it is operating normally to ensure that the equipment remains safe with regard to electromagnetic disturbances throughout the expected service life.

Setting up the generator

• Do not use the RF generator if the AC power cord is damaged. Inspect the cord regularly for wear or damage. Damaged cords could result in patient or user injury.
• The generator produces high voltages on the catheter. Inspect all cords regularly for wear or damage. Discontinue use and discard the cord if damaged. Damaged cords could result in patient or user injury from electric shock.

Protect the generator from exposure to extreme moisture to avoid electric shock and damage to the equipment. To avoid unintentional burns, position the catheter away from the patient when the catheter is connected to the generator but is not in use.

During RF treatment

To prevent injury to the patient, do not start RF power until the catheter is properly positioned in the patient.

RF power activation tones and lights are important safety features.

Do not obstruct indicators or the screen. Do not disable auditory tones.

The generator should not be used adjacent to or stacked with other equipment. If adjacent use is necessary, the generator should be observed to verify normal operation in the configuration in which it will be used.

Do not plug a wet catheter connector into a receptacle as it may damage the generator.

Use of unapproved RF delivery catheters or accessories may result in unanticipated performance, patient/operator safety hazard and increased emissions or decreased immunity to interference. Equipotential cable should be connected when using the generators in medical institutions.

Set up requirements

The RF generator must be set up and put into service according to the guidance provided in this document to ensure proper performance and its electromagnetic compatibility. If in doubt consult Boston Scientific Customer Service or a local distributor.

The generator should be used with only attached power cord and plugged into only grounded hospital-grade AC sources.

The generator requires an AC power source of 110-230 VAC, 50/60 Hz (rated power 120 VA).

Do not stack any items on top of the generator. Doing so could damage the unit.

The generator should not be used adjacent to other equipment. If stacked or adjacent use is necessary, the generator should be observed to verify normal operation in the configuration in which it is used.

The generator can generate EMI at any time. Refer to "Electromagnetic Interference" (EMI) for cautions and warnings. The generator can be placed on any stable cart, table, or platform. Do not have it located so that it could fall onto a patient. It is recommended that a cart have conductive wheels and be rated to hold at least 5.5 kg.

Provide at least 10 cm to 15 cm of space around the sides and back of the generator for air circulation and cooling. After continuous use for extended periods of time, it is normal for the top to be warm.

The generator cannot be sterilized and must not enter a sterile surgical field.

Essential performance for the generator and associated catheters for electromagnetic compatibility is defined according to "Maximum Voltage Output".

Do not plug the generator into the AC power outlet if any of its surfaces appear to be cracked or damaged.

Do not plug the generator into a damaged outlet. Do not use a damaged AC power cord. Do not use extension cords, multiple portable outlets, or adapter plugs.

Generator screen with logo

Operation of the generator in presence of advisory messages may result in radiofrequency therapy not being performed properly. The generator may not allow treatment to continue if the cause of the advisory message is allowed to persist.

• Advisory messages automatically clear when conditions causing the messages are gone.

Inspect the catheter cable for damage. If there is any, do not use the catheter.

Damage could result to the catheter and the RF generator if they are forced together when not aligned.

Cedar Endovenous Radiofrequency Catheters treatment, precautions

Do not activate RF power until the catheter is properly positioned in the patient.

Service & maintenance

Protect against harmful ingress of water or particulate matter. Generator classification: IPX0 (no protection).

Fuses must be replaced with 2 A/250 V, 5 x 20 mm fast-acting fuses. Using other fuses might damage the unit.

Always unplug the AC power cord prior to cleaning the generator.

Do not immerse the AC power cord in water or other cleaning solution.

Avoid getting cleaning materials inside generator receptacles.

As with any AC-powered electrical device, care must be taken to prevent liquid from entering the generator to avoid electrical shock hazard, fire hazard, or damage to electrical components.

Failure to follow the cleaning procedures described herein could result in hazards to users.

Touch Screen: The recommended agent for cleaning the surface is IPA in water, 70/30. Alcohol wipes and pads are acceptable. Do not use abrasive agents or solvents.

Allow 15 minutes after cleaning for the excess cleaning agent to evaporate before turning on the generator.

Generator surfaces (other than the touch screen): The recommended agents for cleaning, to prevent surface degrading or discoloration, are:

• Five percent solution of household bleach (approximately 0.25% Sodium Hypochlorite). Disinfecting wipes or pads that contain only Sodium Hypochlorite are acceptable.
• IPA in water, 70/30.

All surfaces, including the bottom side of the generator and any surface on which it is placed, must be cleaned of any residues. If after cleaning, the generator still has debris or residue, repeat the cleaning steps outlined above. If thorough cleaning attempts fail to remove the debris or residue, the generator should be disposed of to avoid potential safety risks and environmental hazards.

The generator cannot be sterilized and must not enter a sterile surgical field.

None.