Contact us at info@fcaresystems.com for more information about current equipment rental options in your region.

The four main phases of thermocoagulation are:

1. Ionic agitation: Ions in the tissue vibrate rapidly, creating heat.
2. Dehydration: The heat evaporates the water within and between the cells, causing the tissue to shrivel.
3. Denaturation of proteins: The tissue contracts as the proteins break down.
4. Coagulation: The tissue coagulates and dies.

Our intro to RF ablation page provides some additional information.

Monopolar RF devices create a loop of alternating current: generator, electrode, patient’s body, generator, back and forth. Many procedures also use an electrosurgical pad, which is placed elsewhere on the patient’s body; the pad is larger than the electrode, so the energy is focused at the tip of the electrode but more diffuse at the pad (which prevents burns). Monopolar RF provides a predictable thermal effect and can be used in a variety of ways, such as coagulation, electrosection, dessication and fulguration.

Bipolar devices, on the other hand, use two electrodes—for example by gripping the tissue in a pair of forceps. The current takes the path of least resistance, which in this case means travelling straight from one electrode to the other electrode without passing through the patient’s body. As a result, bipolar RF energy cannot penetrate very far (half the distance between the two electrodes), but it is useful for superficial treatments, and unlike monopolar RF, it is safe for patients with pacemakers or other medical implants.

Check the instructions for use for the procedure in question to find out about potential adverse effects and complications.

Yes! F Care Systems offers regular small-group workshops where specialists demonstrate procedures in actual treatment settings. Click here for more information. 

Rafaelo stands for RadioFrequency Ablation of hAEmorrhoids under Local Anaesthesia. It is a minimally invasive technique that employs high-frequency (4MHz) electromagnetic waves to treat haemorrhoids.

Rafaelo® gives you another safe, reliable tool in your toolbox—a procedure that is simple to perform, easy to control, and provides lasting results without damaging surrounding structures.

1. Insert the anoscope into the patient’s rectum to locate the hemorrhoid to be treated.
2. Use a syringe (inserted at a 30° angle) to inject local anaesthetic into the submucosal layer of the haemorrhoid.
3. Insert the HPR45i probe into the haemorrhoid and deliver RF energy.
4. After that, apply RF energy to the surface of the haemorrhoid.
5. Use a compress soaked in cold saline to cool the treated area. 

Over the next two weeks, the thermocoagulated tissue will naturally slough off and leave the body as waste

Rafaelo® is a quick and easy procedure—estimated treatment time in outpatient settings is around 20 minutes. Most importantly, treatment causes patients minimal discomfort, so they can resume their usual activities immediately.

• Quick learning curve (RF generator presets, intuitive controls)
• Suitable for Grade II, Grade III and some Grade IV internal haemorrhoids
• Safety features on RF generator provide added security—no damage to surrounding tissue
• No risk of major complications; minimal post-treatment care
• Well-suited to outpatient treatment settings
• Particularly effective for treating haemorrhage
• Over 96% of patients would recommend Rafaelo® to others

• Minimally invasive, no incision required
• Quick procedure (estimated outpatient treatment time: 20 minutes)
• Very little pain
• Allows immediate return to daily activities—no post-operative care required

Every new technique involves a certain initial learning curve, but overall, it is a very straightforward process. Contact F Care Systems regarding opportunities for in-person or online training.

The Rafaelo® procedure uses the principle of radiofrequency thermocoagulation to treat Grade II, Grade III, and early Grade IV internal haemorrhoids.

Rafaelo greatly reduces or eliminates prolapse in a vast majority of patients.

Only haemorrhoids that arise from the internal haemorrhoidal plexus (i.e., above the dentate line) should be treated using the Rafaelo® method.

You can treat up to 3-4 piles per session.

No, one session is sufficient to treat internal haemorrhoids with RF technology.

Yes, patients can undergo multiple Rafaelo® procedures. We recommend waiting four to six weeks between sessions.

We recommend putting the patient in the lithotomy position, but the knee-elbow and left-lateral positions can be used as well.

Though the procedure can certainly be performed under general or spinal anaesthesia, local anaesthesia alone is preferable because it allows interaction with the patient.

When patients are awake during the procedure, they can let you know if they feel any discomfort, which often means that too much energy has been applied to that location (the probe needs to be repositioned).

If the patient complains about heat at the beginning of the procedure, it’s probably a sign that not enough anaesthetic has been administered.

Yes, you should always use local anaesthetic to help prevent post-treatment pain and protect the muscle layer. Lift the haemorrhoid away from the muscle and apply the local anaesthetic to the submucosal layer beneath the pile.

Any standard solution is fine—xylocaine, lidocaine, etc. We recommend waiting to use adrenaline until after you have performed the procedure a few times, so that you can familiarise yourself with the process without the adrenaline’s additional haemostatic effect.

Insert the anaesthesia needle at a 30-degree angle and apply it to the submucosal layer between the muscle and the base of the pile. Never inject it directly into the haemorrhoid itself, as it will prevent coagulation.

Insert the needle probe immediately after administering the anaesthetic, as the anaesthetic will cause the haemorrhoid to swell.

Yes. Administer local anaesthetic for each pile separately, just before beginning the coagulation process, as it will cause the haemorrhoid to swell. Local anaesthetic will protect the underlying muscle layer and prevent post-treatment pain or damage to surrounding tissue.

No. The pain-sensitive inferior rectal nerve ends below the dentate line, whereas Rafaelo® is only performed above it, so the procedure is practically painless.

Yes, the HPR45i probe is a single-use (consumable) product; after using it, dispose of it accordance with local regulations.

Insert the probe into the haemorrhoid using the same access point and approach as for local anaesthesia. After inserting the probe, lift the haemorrhoid slightly to protect surrounding tissue layers. Rotate the probe between thumb and index finger while coagulating. If necessary, withdraw the probe periodically to remove residual coagulatum. Apply energy while withdrawing the probe in order to close the access point.

Subsequent external coagulation (applying energy to the surface of the pile) will accelerate healing.

Insert the probe far enough to reach the feeder vessels, using the ridge near the tip of the catheter as a maximum depth indicator. Lift the haemorrhoid toward the centre of the anal canal; doing so will prevent inadvertent thermocoagulation of muscle tissue.

Watch for the haemorrhoid to turn a pale pink, which is a sign of successful thermocoagulation. No need to continue applying energy until the haemorrhoid has gone completely white. Excess energy will cause a chain thermal reaction from cell to cell, eventually reaching the muscle layer and causing pain. Make sure to cool the treated area to minimise the risk of thermal radiation.  

In any case, stop administering energy once the maximum total joules has been reached depending on the size and degree of the pile in question. Larger piles will require periodic repositioning of the probe. Use the table below as a general guide:

Reset to 0 W/s each time you move to a new pile.

Applying energy to the surface of the haemorrhoid (external coagulation) can accelerate the healing process.

Releasing the foot pedal will stop the flow of energy (0 W/s).

Cooling helps prevent heat from radiating to the muscle layer, which could cause post-treatment pain.

If pulsatile bleeding occurs, don’t panic—simply use the HPR45i probe to coagulate the wound. Do keep a suture kit on hand just in case, however. 

• First 24 hours: Coagulation
  (Stage I: vessel constriction; Stage 2: clot formation)
• Day 1-3: Fibrosis
• Day 4-6: Tissue necrosis
• Day 7-14: Exfoliation of necrotic tissue, wound formation
  (Note: slight bleeding may occur here, though it often goes unnoticed)

• End: Scar tissue formation

We recommend scheduling a follow-up examination four weeks after treatment.

In general, very little post-treatment care is required. Studies have shown that two-thirds of patients require only OTC painkillers, though analgesics can certainly be prescribed if necessary (2-3 per day). Other prescription options include anti-inflammatory agents like ibuprofen (to reduce swelling), lidocaine ointment (for pain), and lactulose (to prevent constipation).

Rafaelo® is contraindicated for:

• People with heart disease
• Pregnant patients, including breastfeeding
• Patients younger than 18 years
• Allergy to nickel
• Allergy to Chromium Nitride (CrN) when using Rafaelo, Sphera probe
• Patients with metal implants or other active implantable devices such as pacemakers
• Anal fissures
• Infective anal pathologies like cryptitis & proctitis
• Allergic to substances used in tumescence
• Presence of staples from previous Longo treatment
• Patients with bleeding disorders

IMPORTANT: The patient must be informed about the relevant contraindications, possible side effects and complications before start of the treatment.
Before the treatment, it is advised to perform a rectoscopy analysis to look for serious diseases: rectal cancer(carcinoma) or polyps. If the patient recently had a rectoscopy or colonoscopy then another rectoscopy analysis is not required.

Following side effects and complications can be experienced during or after the Rafaelo treatment:

• Bleeding (including mild serosanguineous bleeding)
• Anal fissure
• Chronic/delayed healing wounds or ulcers
• Diarrhea/ constipation
• Discharge
• Fever (including chills)
• Hyposensitivity of the anal canal
• Incontinence (fecal or flatus)
• Increased anal tension
• Infection
• Abscess
• Marginal clot
• Marginal haematoma
• Oedema
• Pain (mild or severe)
• Pruritus
• Skin tag formation
• Tenesmus
• Thrombosis
• Urinary retention

We don’t currently offer Fistura® Workshops, but we can arrange a personal training. Please contact us for more information.

Fistura® is contraindicated for:

• People with heart disease including pacemaker
• Pregnant patients, including breastfeeding
• Patients younger than 18 years
• Contraindication to local anaesthetic
• Anal pathologies
• Anal fissures
• Residual Longo anterior treatment staples
• Contraindication to MRI

The patient must be informed of the following potential side effects before start of the treatment. Following side effects and complications can be experienced during or after the treatment:

• Postoperative abscess
• Hematoma
• Pain
• Bleeding
• Incontinence
• Local infection
• Tissue necrosis

WARNINGS

• It is possible that the product causes interference, which may adversely influence operation of other electronic equipment.
• To avoid any eventual disruption, don’t use the apparatus near another sensitive high frequency device.
• For more information regarding type and methods to reduce risks related to radiation, please see the user manual of the compatible F Care Systems RF generator.
• Do not use the catheter in case of damaged packaging or if it has accidentally been opened.
• Substances used to clean the fistula tract must be removed as much as possible before starting the Fistura treatment.
• Alcohol based substances are forbidden, Natrium and Iodine based substances should be avoided as they can change the electric behavior of the energy coming from the Fistura catheter.
• Abide to the treatment protocol as applying excessive energy can lead to tissue necrosis.
• It is possible that the product causes interference, which may adversely influence the operation of other electronic equipment.
• To avoid any eventual disruption, don’t use the apparatus near to another sensitive high frequency device.
• For more information regarding type and methods to reduce risks related to radiation, please see the user manual of the compatible F Care Systems RF generator.

PRECAUTIONS

• Patients may not be grounded or connected to any other radiofrequency device.
• Care and vigilance must be exercised when treating patients who are on aspirin or anticoagulant therapy, due to the possibility of increased bleeding.
• Care and vigilance must be exercised when treating patients who suffer from hyper coagulopathy.
• The patient must be informed about the relevant contraindications, possible side effects and complications before start of the treatment.
• Ask the patient about any known allergies before administering any type of anesthetic agent.

True to its name, the EndoVenous RadioFrequency generator is tailored to all things varicosity-related: saphenous veins, perforator veins, collateral veins, spider veins, etc. The generator sends 4MHz radio waves to the electrode (the non-insulated tip of the catheter). When the electrode touches the wall of the vessel being treated, it causes the tissue to coagulate.

The four stages of thermocoagulation:

1. Ionic agitation: ions in the cells vibrate very quickly as they try to follow the alternating current back and forth. This creates friction, which generates heat.
2. Dehydration: the heat causes the water within and between the cells to evaporate, which dries out the tissue.
3. Denaturation: the proteins within the tissue break down.
4. Thermocoagulation: the tissue coagulates as the cells die.

Veineo catheters are strong yet highly flexible and contain their own guidewires, which makes it easy to follow tortuous veins without requiring a separate guidewire. The catheters come in a range of sizes suitable for treating not only saphenous veins but smaller branch vessels as well, and their smaller electrodes facilitate treatment of the vein along its entire length while preserving the surrounding structures. Moreover, they can be used with common 6F introducers, whereas many other systems require 5F or 7F sets. 

The generator creates heat (approx. 120°C) the instant the foot pedal is pressed, and the heat dissipates immediately when it is released. Convenient presets make the process quick and easy to learn, and the generator provides visual and auditory guidance on how quickly to proceed.

The basic procedure is to withdraw the catheter by one marking each time the generator emits a visual and audible signal (for example every six seconds), but be sure to familiarise yourself with the instructions for that particular procedure before starting treatment. Use ultrasound guidance to confirm successful thermocoagulation.

You can reduce the wattage depending on the size and location of the vein—check the instruction manual and the EVRF® presets for details.

Veins will partially occlude immediately following treatment; complete occlusion may take up to six months.

No, the tumescence compresses the vein and protects the surrounding tissue.

Yes, we recommend wearing compression stockings for 2-3 weeks following RF ablation.

There are no restrictions on frequency of treatment.

Veineo® is contraindicated for:

• People with heart disease
• Pregnant patients, including breastfeeding
• Patients younger than 18 years
• Allergy to nickel
• Allergy to Chromium Nitride (CrN) when using Rafaelo, Sphera probe
• Patients with metal implants or other active implantable devices such as pacemakers
• Deep venous insufficiency
• Obstructed deep venous system
• Deep vein thrombosis
• Allergy to substances used in tumescence
• Hyper coagulopathy
• Congenital vasculopathies
• Thrombophilia
• Sciatic vein reflux
• Occlusive peripheral arterial disease

The patient must be informed of the following potential side effects before start of the treatment. Following side effects and complications can be experienced during or after the varicose vein treatment:

• Bruising
• Skin hyperpigmentation
• Paraesthesia
• Phlebitis and periphlebitis
• Puncture site infection
• Skin burn
• Scar
• Saphenous nerve injury
• Oedema
• Induration
• Pain
• Ulcer
• Thrombophlebitis
• Mild bleeding
• Deep vein thrombosis
• Popliteal vein injury
• Hypersensitivity to metal

WARNINGS

• It is possible that the product causes interference, which may adversely influence operation of other electronic equipment.
• To avoid any eventual disruption, don’t use the apparatus near another sensitive high frequency device.
• For more information regarding type and methods to reduce risks related to radiation, please see the user manual of the compatible F Care Systems RF generator.
• Do not use the catheter in case of damaged packaging or if it has accidentally been opened.
• Stay 10-20 mm away from the saphenofemoral junction when treating the great saphenous vein.
• Stay 1,5 cm away from the Popliteal vein when treating the small saphenous vein (only for CR45i).

PRECAUTIONS

• Patients may not be grounded or connected to any other radiofrequency device.
• Care and vigilance must be exercised when treating patients who are on aspirin or anticoagulant therapy, due to the possibility of increased bleeding.
• Care and vigilance must be exercised when treating patients who suffer from hyper coagulopathy.
• The patient must be informed about the relevant contraindications, possible side effects and complications before start of the treatment.
• Ask the patient about any known allergies before administering any type of anesthetic agent.
• Care and vigilance must be exercised when treating a patient who is on aspirin or anticoagulant therapy, due to the increased possibility of bleeding.
• The patient may not be grounded or connected to any other radiofrequency device. Ask the patient about any known allergies before administering any type of anesthetic agent.
• Prior to treatment, the patient should be informed about contraindications, side effects and possible complications.

We don’t currently offer online training for aesthetic dermatology, but you can download our quick user guide for telangiectasia treatment.

The RF treatment of skin conditions is contraindicated for:

• People with heart disease
• Pregnant patients, including breastfeeding
• Patients younger than 18 years
• Patient with allergy to nickel ( > use gold needles)
• Patients with metal implants or other active implantable devices such as pacemakers

The patient must be informed of the following potential side effects before start of the treatment. Following side effects and complications can be experienced during or after the treatment:

• Pain
• Skin hyperpigmentation
• Skin burns

You’re not alone—haemorrhoids are a very common problem! Fortunately, there are a number of home remedies you can try:

• Some haemorrhoids will respond well to simple lifestyle changes, such as eating more high-fibre foods (wholemeal products, pulses, fruits and veg). If these aren’t currently part of your diet, add them in slowly to prevent gas.
• Soak the area in warm water for 10-15 minutes, two to three times per day. You can use a sitz bath (a shallow basin that fits over your toilet bowl) or just fill your bathtub with a few inches of plain water with or without bicarbonate of soda. Don’t add soap or bubble bath to the mixture, as it could cause irritation.
• Over-the-counter haemorrhoid treatments (creams, ointments, suppositories, medicated wipes, etc.) containing hydrocortisone, lidocaine or phenylepinephrine can help relieve pain and swelling. If you prefer natural ingredients, look for products containing witch hazel. 

You can also take oral pain relievers (paracetamol, aspirin, ibuprofen, etc.), but don’t rely on them for long—consult your doctor if the symptoms last longer than a week.

Rafaelo® stands for RadioFrequency Ablation of hAEmorrhoids under Local Anaesthesia. (“Ablation” means removal.) It’s a minimally invasive method of treating haemorrhoids using radio waves: the doctor inserts a thin needle probe into the pile and heats it using radiofrequency energy. This destroys the proteins inside the tissue, which causes the pile to shrivel up and scar. Over the next two to three weeks, a scar will form, and the dead tissue will be sloughed out of the body naturally.

The heat used in RF ablation isn’t the same “spreading” burn you’d feel if you put your hand on a stove. (Which we obviously don’t recommend.) In fact, the RF probe itself isn’t hot at all! Instead, the probe creates a energy field measuring just a few millimetres; the molecules inside that tiny field vibrate very quickly, which causes friction that creates heat and destroys the haemorrhoid tissue. Outside the field, however, the molecules stay still, so they don’t generate heat.

To contain the energy even further, the doctor injects local anaesthetic at the base of the pile, which creates a protective barrier between the treatment area and the underlying muscle. This is important, because internal haemorrhoids themselves don’t have sensory nerves (the kind that feel pain), but the surrounding tissue does. After treatment, the doctor cools the area down to prevent any remaining heat from spreading.

Though the treatment itself doesn’t hurt, you might feel some mild discomfort in the following days. Your doctor can prescribe you some painkillers if necessary, though most patients don’t require them.

Rafaelo® is safe, effective, and offers lasting results. It’s a very quick procedure (usually about 20 minutes) that doesn’t require surgery or a hospital stay, and most patients can go right back to their usual daily routines.

Most patients return to work the very next day, but some may prefer an extra day or two of R&R. Talk to your doctor about what to expect in your case. You may notice a small amount of bleeding a few days later. If so, don’t panic! That’s a normal part of the process—your body is sloughing off the treated tissue naturally. The overall healing process will take about three to four weeks.

Rafaelo® is intended to treat Grade II, Grade III and some Grade IV internal haemorrhoids, but of course no two patients are alike! Speak to your doctor about whether Rafaelo® is the best option for you.

No—there’s no risk of incontinency at all.

Numerous healthcare facilities and private clinics worldwide offer the Rafaelo^® procedure. To find the providers nearest you, email us at info@fcaresystems.com.

Rubber band ligation is a very common procedure: the doctor uses a special tool to wrap a very small rubber band around the base of the pile, which cuts off its blood supply; over the next few weeks, the haemorrhoid shrivels up and falls off. Other minimally invasive methods include sclerotherapy (injecting a hardening agent into the pile, which causes it to collapse), cryotherapy (freezing the haemorrhoid off), laser therapy and stapling. In some cases, your doctor will recommend a traditional haemorrhoidectomy, which means removing the haemorrhoid surgically.  

As with many things, an ounce of prevention is worth a pound of cure: even if you have already developed haemorrhoids, healthy lifestyle changes (eating more fibre, not straining on the toilet, etc.) can help keep them from getting worse.

The pile typically drops off about six to eight weeks after the procedure.

Contact us at info@fcaresystems.com for more information on provider locations.

Once a vein is varicose, it can’t technically be “cured”—treatment involves removing or close the damaged vein so that the body will redirect blood to healthy vessels. At F Care Systems, we offer products related to two methods: RF ablation (in which the doctor inserts a very thin catheter and uses radiofrequency energy to break down the vein walls) and sclerotherapy (which uses a chemical sclerosant, or hardening agent, to collapse the vein and seal it shut).

Common prevention methods include compression stockings, regular exercise, avoiding long periods of sitting or standing, and elevating the legs when seated. See our patient information page for more details!

[tel-an″je-ek-ta´zhah] 

“Tell-AN-gee-eck-TAY-zee-uh” (or “TAY-zhuh”). It rhymes with “Fantasia” (like the Disney movie). …but you can also just say “spider veins”😉