14 manual evrf e d - f care systems€¦ · manual thermocoagulation - evrf date 27/07/2015 page 3...

MANUAL THERMOCOAGULATION - EVRF

Date 27/07/2015 Page 1 de 49 Revision N° : 14

MANUAL EVRF

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F CARE SYSTEMS NV

Oosterveldlaan 99

B-2610 - Antwerp - Belgium

TEL: +32 3 451 51 45

FAX: +32 3 451 51 39

WWW.FCARESYSTEMS.COM



We thank you for your confidence

The PRODUCT includes a plan of two years guarantee covering:

- All the spare parts

- Working-hours

This guarantee is only applicable on the condition that the guarantee card is returned to F care systems and that all the clauses of safety measures were applied strictly. For this we ask you to read the chapter SECURITY INSTRUCTIONS of this manual.

For any further information or any technical problem concerning the product, we will stay fully at your disposal.

READ THE INSTRUCTIONS BEFORE CONNECTING THE INSTRUMENT IN SERVICE

THE USE OF THIS DEVICE IS RESERVED ONLY TO PEOPLE WHO ARE QUALIFIED AND TRAINED ON THE SUBJECT

ALL THE INSTRUCTIONS OF THIS MANUAL MUST BE FOLLOWED STRICTLY.



GUARANTEE CARD

This card must be returned to F care systems within 15 days after reception of the

EVRF.

F care systems NV

Oosterveldlaan 99

B-2610 - Antwerp - Belgium

NAME : ……………………………………………………………………………………………….

ADDRESS : …………………………………………………………………………………………………

…………………………………………………………………………………………………

POSTAL CODE : ……………………………………………………………………………………

TOWN :…………………………………………………………………………………………

COUNTRY :…………………………………………………………………………………

EVRF N° : ……………………………..

received on : …………………………….

I, undersigned (name and function)............................................................ state to have taken knowledge of the chapter of security instructions of this user’s manual and I engage, in the name of my establishment, to apply it and to make it apply.

NAME and SIGNATURE STAMP



Summary

SUMMARY ....................................................................................................................................................... 4

1 SECURITY INSTRUCTIONS ........................................................................................................................ 6

1.1 ELECTRICAL SECURITY ..................................................................................................................................... 6

1.2 ELECTROMAGNETIC DISRUPTION ....................................................................................................................... 6

1.3 PROTECTION AGAINST EXPLOSION ..................................................................................................................... 6

1.4 SECURITY BY INSTALLATION .............................................................................................................................. 6

1.5 SECURITY DURING USE .................................................................................................................................... 7

1.6 TECHNICAL CONTROL ...................................................................................................................................... 7

1.7 GUARANTEE AND LIABILITIES ............................................................................................................................ 7

1.8 CLEANING AND SERVICING ............................................................................................................................... 8

1.9 IN CASE OF PROBLEMS ..................................................................................................................................... 9

1.10 PRACTICAL ADVICES ................................................................................................................................. 10

1.11 RESTRICTION STERILE CATHETERS ................................................................................................................ 10

2 TECHNICAL CHARACTERISTICS ............................................................................................................... 11

2.1 GENERAL CHARACTERISTICS............................................................................................................................ 11

2.2 EXPLANATION OF THE SYMBOLS ...................................................................................................................... 11

2.3 OUTPUT CHARACTERISTICS ............................................................................................................................. 12

2.4 LABEL EXPLANATION ..................................................................................................................................... 12

2.5 FUNCTIONING ............................................................................................................................................. 12

2.6 DECLARATION OF CONFORMITY ...................................................................................................................... 13

3 INDICATION FOR USE ............................................................................................................................ 14

3.1 SPIDER VEINS AND TELANGIECTASIAS ............................................................................................................... 14

3.2 VARICOSE VEINS .......................................................................................................................................... 14

3.3 SAPHENA PARVA AND SAPHENA MAGNA. .......................................................................................................... 14

3.4 HEMORRHOIDS ............................................................................................................................................ 14

3.5 CONTRA INDICATIONS ................................................................................................................................... 15

4 DESCRIPTION OF THE EVRF AND THE ACCESSORIES ............................................................................... 16

4.1 FRONT FACE OF THE EVRF ............................................................................................................................. 16

4.2 BOTTOM SIDE OF THE EVRF........................................................................................................................... 16

4.3 ACCESSORIES ........................................................................................................................................... 16

4.3.1 Foot pedal ...................................................................................................................................... 16

4.3.2 3M cable ........................................................................................................................................ 17

4.3.3 Needle-holder pen (with cable of connection)............................................................................... 17

4.3.4 Needles .......................................................................................................................................... 17

4.3.5 Insertion needles ........................................................................................................................... 17

4.3.6 CR12i and CR30i catheter with handset ........................................................................................ 18



4.3.7 CR45i catheter and 6 French Introducer ........................................................................................ 18

4.3.8 The 3M Pad ................................................................................................................................... 18

4.3.9 HPR45i probe ................................................................................................................................. 18

5 USE OF THE EVRF SYSTEM ..................................................................................................................... 19

5.1 CONFIGURATION OF THE EVRF ....................................................................................................................... 20

5.1.1 Language settings ...................................................................................................................... 20

5.1.2 Screen contrast .............................................................................................................................. 20

5.2 USE OF THE EVRF ........................................................................................................................................ 21

5.2.1 Needle holder ................................................................................................................................ 21

5.2.2 CR12i & CR30i catheter ................................................................................................................. 22

5.2.3 CR45i catheter : ............................................................................................................................. 23

5.2.4 Hemorrhoids .................................................................................................................................. 24

5.2.5 End of the care .............................................................................................................................. 24

6 TREATMENT PROTOCOLS ...................................................................................................................... 25

6.1 NEEDLE HOLDER .......................................................................................................................................... 25

6.1.1 The equipment............................................................................................................................... 25

6.1.2 Screen Needle holder ..................................................................................................................... 26

6.1.3 Treatment ...................................................................................................................................... 26

6.1.4 Pragmatic approach ...................................................................................................................... 27

6.1.5 Contra-indications ......................................................................................................................... 29

6.1.6 Advantage of Thermocoagulation ................................................................................................ 29

6.1.7 Conclusion – Discussion ................................................................................................................. 30

6.2 CR12I & CR30I CATHETER ............................................................................................................................ 30

6.2.1 The equipment............................................................................................................................... 30

6.2.2 Screen ............................................................................................................................................ 31

6.2.3 Treatment ...................................................................................................................................... 31

6.3 CR45I CATHETER ......................................................................................................................................... 34

6.3.1 The equipment............................................................................................................................... 34

6.3.2 Screen ............................................................................................................................................ 34

6.3.3 Treatment ...................................................................................................................................... 35

6.3.4 Set-up and use of EVRF pads ......................................................................................................... 38

6.4 HEMORRHOIDS ............................................................................................................................................ 39

6.4.1 The equipment............................................................................................................................... 39

6.4.2 Screen ............................................................................................................................................ 39

6.4.3 Treatment ...................................................................................................................................... 40

6.5 EVRF QUICK USER GUIDE ............................................................................................................................. 41

7 ANNUAL CONTROL FORMS ................................................................................................................... 43

8 DEFECT REPORT FORM .......................................................................................................................... 49



1 SECURITY INSTRUCTIONS

1.1 Electrical Security

Check that the electrical safety provisions of the place where the equipment will be

installed comply with current regulations, before the apparatus is taken in service.

Risk of damaging the apparatus in case of excessive voltages or mains cut.

Check if the voltage and the frequency indicated at the back of the apparatus, are conform to the electricity mains of the region.

The apparatus must only be used with the cable provided together with the device. It must always be connected to a ground plug, conform to the local regulations for medical premises.

In case of usage of an power cable extension cable, the leakage currents may increase. The apparatus, in this case, might not be conform to security standards anymore.

1.2 Electromagnetic disruption

The apparatus is equipped with a filter for mains suppression. To avoid any eventual disruption, don’t use the apparatus near to another sensitive high frequency device. (Doppler, Pacemaker, etc.)

1.3 Protection against explosion

The apparatus must be disconnected from the power when the room, where the apparatus is located, is disinfected.

Don’t use the apparatus in places where flammable gas or steam is present.

1.4 Security by installation

The apparatus cannot be installed at a location with high atmospheric dampness.

Avoid penetration of any liquids inside the apparatus because it is not watertight.

Don’t let the apparatus get wet.

If liquid has penetrated into the apparatus, stop the treatment immediately and disconnect the apparatus from the mains. Have the apparatus checked by a competent person.

Don’t expose the apparatus to high temperatures (>40°C).

Don’t install the apparatus near a heat source (e.g. central heating) and never under the direct light of the sun.

Never cover the ventilation grate at the back of the apparatus. These vents must be free to provide good air circulation.

Don’t expose the apparatus to rain.

The apparatus may never undergo vibrations.

Don’t keep the apparatus in places where the temperature is lower than 10°C.



1.5 Security during use

At the end of the treatment, make sure that you “switch off” the apparatus.

Immediately replace any defective cable.

It is recommended that the patient is not connected with the applied parts before the apparatus has been switched ON.

The apparatus must only be used with accessories, maintenance parts, and consumption products, of which the technical security on use has been controlled and approved by a control organism, entrusted with the mission of control of the apparatus and its accessories.

It is important to inform the patient about the sensation he or she will feel during treatment with the device. The treatment is not for:

People who are prone to diseases.

People who do not understand (mentally) what will happen or who are not rational enough to distinguish between “normal” and “abnormal” (comatose patients, non-intellectual people).

People who can’t express themselves or reveal abnormal sensations (infants, elderly).

People with epilepsy, heart failure, pregnancy.

People who refuse the treatment.

1.6 Technical control

The user must submit the apparatus to technical control, conform the medical instructions 93/42/CEE, at least once a year or after each repair.

This technical control consists of:

a. Visual monitoring and cleaning of EVRF.

b. Securities control.

c. A control of all functions.

d. Measurement of output signals.

e. Control of the foot pedal.

f. Control of the needle holder.

g. Measurement of leakage currents.

The results of this control must be collated on the control form (at the end of this manual) and must be realised by competent people who are recommended by the company F CARE SYSTEMS.

1.7 Guarantee and liabilities

Conditions of guarantee:

The device comes with a 2 year guarantee and 7 years on spare parts, from the day of the purchase (mentioned on the invoice which you have to store).

Are in guarantee: manufacturing defects and the repairing of hidden defaults once they have been proved.



Also falls under warranty: the repairing of defective components. The purchaser must inform F CARE SYSTEMS about the expiry date of the guarantee, by registered letter with acknowledgement of receipt.

No compensation can be asked as a prejudice due to the immobilization of the apparatus. The pick-up and return charges are for the purchaser.

The yearly guarantee mentioned doesn’t apply for: the repair of a breakdown or mistakes due to a bad use of the apparatus or of its accessories, an erroneous interpretation of the manual, negligence or an accident, bad maintenance of the device or a repairing of the apparatus realised by an incompetent person - not recommended by F care systems.

Not covered by warranty:

Incorrect operation of the device

The regulations, repairs or modifications effectuated by the purchaser or by a third party not recommended by F care systems.

Damage of the delivery device (box, housing, display) caused by the transport or by dropping it.

Any external interventions, fire, lightning, flood, natural disaster, explosion, war, excessive voltage, etc...

If proved that the apparatus has been opened.

If the identification of the apparatus has been changed or modified.

If the guarantee form has not been returned within 15 days after the delivery date, incorrectly or incompletely filled in.

Liabilities:

After a period of 10 years since purchasing the device, F Care Systems will not be

held responsible for any errors and their consequences

F Care Systems cannot be blamed for any eventual consequences for the device, the user or the patient; for example as wrong use of the device or the accessories, wrong interpretation or no use of the manual, bad maintenance or repair of the device by an incompetent person - not recommended by F Care Systems.

F Care Systems cannot be blamed in case of electrical discharge, cardiac sickness or allergy on a patient due to a bad manipulation, bad connections due to excessive regulations or to a wrong use of the accessories. Neither the manufacturer, nor F Care Systems will be blamed in case of transmission of infections by the needles.

1.8 Cleaning and servicing

AS SECURITY PRECAUTION, DISCONNECT THE APPARATUS FROM THE NETWORK BEFORE ANY SERVICING OR REPAIRING!

In order to give a permanent guarantee of safety and quality of the device, it is prohibited for any incompetent person to open the device or accessories.

Opening the device or its accessories is only reserved for competent people approved by F CARE SYSTEMS.



Apparatus

You can clean the external face of the apparatus with a soft, dry rag or a damp rag.

Don't use aggressive products because they can damage the parts inside the device. In case of streaks or smears, use non aggressive soapy water.

No liquid may penetrate into the apparatus - dry the device carefully after cleaning.

Hygiene

The needles and catheter are sterile and for single use. Never use the same needles and catheter for more patients and wear gloves during the treatment.

Reusing or re-sterilizing the needles or catheters can result in transmission of blood borne pathogens (including HIV and Hepatitis) and endanger patients and operators.

Waste handling

Please, throw the single use products in the appropriate bio-medical waste bins, according to national regulations.

End of life considerations:

At the end of its life, the product is taken out of service. European legislation and sometimes national laws arrange the basic principles on how to treat the product. Different rules apply depending on possible contamination risks. For electrical and electronic equipment, the EU Directive on WEEE deals with recovery and treatment of waste at European level. Recommendations: The user must contact the MANUFACTURER if he is unsure what to do with the product when it is taken out of service.

Fuses

The replacement of the fuses accessible through the fuse holder of the mains power supply must be realised with a flat screwdriver. The two fuses are type F2A/250V in glass 5 mm per 20 mm.

Maintenance

The EVRF device must be controlled annually by F care systems or a company

authorised by F care systems after the warranty has expired.

Transport and storage

The apparatus can be transported and stored in the following environment conditions:

Room temperature between – 40°C and + 70°C

Relative dampness between 10% and 100%

Atmospheric pressure comprised between 500 hPa and 1060 hPa

1.9 In case of problems

- The apparatus doesn’t switch on:

Check if the power cable is well connected to the device and put the switch on "I".



- There is no output signal:

Check first if the pen is well connected to the apparatus. If this is the case there is a problem with the pen itself, so you have to take another one.

1.10 Practical advice

Never place the unit in direct sunlight during treatment.

Place the machine on a solid and flat surface.

Use the EVRF only at temperatures between 10 °C – 40 °C.

Do not expose to rain and moisture.

Entire area of neutral electrode/pad (neutral electrode is only to be used in combination with CR45i, CR30i and CR12i) should be reliably attached to a suitably prepared and appropriate area of the patients’ body. We recommend the lower back, shoulder or buttocks area,

Patient should not come in contact with earthed metal parts or parts with appreciable capacitance to earth (for example table supports),

Monitoring electrodes should be placed away as far as possible from the treatment zone,

It is recommended not to use needle monitoring electrodes,

It is recommended to use monitoring systems incorporating high frequency current limiting devices,

Apparent low output or failure of the EVRF to function correctly may indicate faulty application of the electrode/pad or poor contact in its connections (only if working in CR45i mode),

It is recommended to use non-flammable agents for cleaning and disinfecting wherever possible,

It is possible that the EVRF causes interference, which may adversely influence operation of other electronic equipment

1.11 Restriction sterile catheters

The following restrictions are applicable for the sterile accessories catheters CR12i, CR30i CR45i and probe HPR45i:

- Do not use in case of damaged packing or if in doubt about sterility

- Do not use after expiration date, expiration date is shown on label

- Do not sterilise the accessories after use, the accessories should be disposed after end of treatment.

- Do not use the accessories on multiple patients, the accessories should be disposed after end of treatment.

- Only use for approved applications (see chapter 3 Indication for use).



2 TECHNICAL CHARACTERISTICS

2.1 General characteristics

Supply Voltage: 110-230V / 50-60Hz ~

Power : 125VA

BF type apparatus

Protection degree against liquid penetration : IPX0

Temporized fuse in glass.

Work in continuous.

Dimensions : H = 360 mm, D = 280 mm, W = 120 mm

Weight :+/- 5 Kg

Class IIa apparatus

Insulation: class I

!

Output of the thermo-coagulation (HF) signal

Fuse reference : 2x F2A / 250V

2.2 Explanation of the Symbols

Confirm

Cancel

Select

Reduce power

Raise power

Reduce impuls

Raise impuls

Once you press this button, the device is ready for use

Switch on/ Switch off button 1 0



Session timer

The number of impulse per session

Type BF device

CE marking

Read manual before use

U Allowed voltage

FREQ Frequency

P Maximum power

2.3 Output characteristics

This apparatus generates some high frequencies impulses whose characteristics are:

frequency of the wave : 4 MHz

max voltage in output : 600V (+/- 20 V)

max time of impulse : 0,8 s (+/- 0.01 s)

continuous mode

2.4 Label explanation

1: Type BF apparatus

2: Name + address of fabricant

3: CE number

4: Read operating manual before usage

5: Model/apparatus name

6: Serial number

7: Technical specifications

2.5 Functioning

The apparatus works in the following environment:

Room temperature between +10°C and + 40°C

Relative dampness comprised between 30% and 80%, condensation comprised

Atmospheric pressure comprised between 700 hPa and 1060 hPa

The power supply cannot exceed a voltage of 230V~+-10% for the rated voltage.



Declaration of conformity

DECLARATION OF CONFORMITY

We, F Care Systems NV Oosterveldlaan 99, B-2610 Wilrijk, Belgium

hereby declare that under our sole responsibility that the CE marked product to which this

declaration relates,

Product type: Thermocoagulator using radiofrequency ablation intended for treatment of varicose veins, spider veins and hemorrhoids,

including treatment of the great saphenous vein (vena saphena

magna) and small saphenous vein (vena saphena parva).

Product name: EVRF

Has been classified as Class IIb, according to annex IX, rule 9, of the Medical Device

Directive93/42/EEC

and is in conformity with the essential requirements and provisions of the Council Directive

93/42/EEC concerning medical devices

and is in conformity with the relevant harmonized standards:

EN ISO 13485 IEC 62304

IEC 60601-1 EN ISO 14971

IEC 60601-1-2 IEC 60601-2-2

and is subject to the procedure set out in Annex II of the Council Directive 93/42/EEC.

This declaration is made on base of quality assurance certificate N° BE 10/23574093 Delivered by SGS Belgium, N° 1639

Signed,

Name : Rudi Devers Function: Managing Director On: 03/08/2015



3 Indication for Use

3.1 Spider veins and Telangiectasia

The EVRF has a connection cable to the needle holder which accepts small insulated needles

to treat spider veins and telangiectasia. The EVRF software allows the user to pre-set an

energy level and an impulse time so that the exact energy can be administered to coagulate a

small spider vein.

Spider veins are small veins on the legs or the face with a diameter between 0,3 and 0,9 mm

which are treatable with the EVRF radio frequency.

3.2 Varicose veins

The EVRF has a special connection to the CR12i and CR30i handset catheters. These

handsets contain a small catheter which can be inserted into a varicose vein through a 20 or 24

gauge access needle.

The catheters are flexible and can be routed through veins that are not too tortuous.

The EVRF software allows the user to set the energy level so that the varicose vein can be

coagulated. The tip of the flexible PTFE coated catheter is from steel and the RF energy

allows the tip to heat so that the vein coagulates.

The CR12i allows the coagulation of varicose veins with a diameter of about 1.5 to 3mm.

The CR30i allows the coagulation of varicose veins with a diameter of about 2 to 5mm.

3.3 Saphena parva and saphena magna.

The EVRF has a connection to a CR45i catheter which because of its larger diameter can

coagulate the large saphenous vein and the small saphenous vein.

The energy to be supplied is indicated by the lights on the EVRF device or by the sound that

each light accompanies.

The catheter is also covered with a PTFE coating. The tip of the catheter is in metal and

conducts the radio frequency signal in the vein wall. The 4 MHz vibrations of the tip make the

cells in the vein wall increase in temperature and coagulate.

Saphena magna with diameters between 5 and 18mm can be treated with the EVRF and the

CR45i catheter.

3.4 Hemorrhoids

The EVRF has a connection to the HPR45i probe, which is a small stiff probe with a non-

insulated tip. The EVRF delivers energy the same way as with the CR45i catheter to the tip of

the HPR45i probe so that the tip makes the hemorrhoidal tissue heat up and coagulate.

Hemorrhoids are also vein based so that the coagulation of the hemorrhoid will make it shrink

and fall off or disappear. Hemorrhoids of grade 2, 3 and 4 can be treated with the EVRF and

the HPR45i probe.

The fact that the outer part of the hemorrhoid is hardened because of the coagulation will

make the hemorrhoid stop growing and will make it shrink.



3.5 Contra Indications

Allergy to nickel and chromium (use a gold needle, for spider vein treatment only)

Heart disease (including pacemaker)

Cutaneous infection

Pregnancy

Only for the HPR45i treatment:

Anal fissures

Infective anal pathologies like cryptitis & proctitis



4 DESCRIPTION OF THE EVRF AND THE ACCESSORIES

4.1 Front face of the EVRF

4.2 Bottom side of the EVRF

1. Main power supply +

fuse holder + ON/OFF switch

2. Cooling fan

4.3 Accessories

The accessories of the EVRF are the following:

4.3.1 Foot pedal

The foot pedal permits to activate the high frequency impulses.

It connects the blue connector with the EVRF.

1

2

1

2 3

4

1. Display with touchscreen

2. Connection for the 3M

cable

3. Connection for the needle

holder pen or catheter

(silver)

4. Connection for the foot

pedal (blue)



4.3.2 3M cable

Cable used to connect the neutral electrode (3M pad) to the apparatus

4.3.3 Needle-holder pen (with cable of connection)

Linked to the apparatus, it permits to transmit the high frequency impulses through the needle.

4.3.4 Needles

The apparatus is delivered with a set of Ballet needles.

The needles are nickel, type: “BALLET K3i” (0,075 mm) and “BALLET K6i” (0,150 mm). They have the CE mark imposed by the Directive 93/42/CEE.

4.3.5 Insertion needles

The insertion needles are used to make the initial insertion in the vein. After the insertion has been done you pull the needle out and leave the flexible part in the vein. This flexible part will guide the catheter of the handset into the vein.



4.3.6 CR12i and CR30i catheter with handset

The apparatus is delivered with an F Care handset including cable of connection.

The handset will be used to coagulate the veins from the inside out. The catheter, which is

scrolled out of the handset, can be inserted into the vein for a maximum of 8-10cm.

The CR12i and CR30i are also available in a cable version which is without the handset. This

enables the catheter to be inserted over a longer length.

4.3.7 CR45i catheter and 6 French Introducer

For the treatment of the Saphena Magna a 6 French Introducer and CR45i catheter are used. The CR45i catheter is a special designed catheter for efficient removal of the Saphena Magna.

Thermocoagulation of the Saphena Magna is performed with a 0,5 cm long tip, which is pulled back slowly so the entire vein closes. Smooth and fast insertion is ensured by the advanced coating material around the flexible core.

4.3.8 The 3M Pad

Neutral electrode to be used when working in CR45i or CR12i & CR30i mode. The neutral

electrode is attached to the patient.

3M Pad

4.3.9 HPR45i probe

With the HPR45i probe hemorrhoids degree 2-4 can be treated easily and effectively.



5 USE OF THE EVRF SYSTEM The use of the EVRF is very easy.

Connect the needle-holder pen or handset to the apparatus (metal plug), thanks to the cable provided on this aim.

Connect the foot pedal to the apparatus (blue plug).

Switch on the apparatus, the welcome screen appears. Afterwards the mode selection screen is shown.

The welcome screen is shown for 3 seconds.

Afterwards the mode selection screen is shown.

In this menu you have the option to choose between 4 modes:

-Telangiectasia with needle holder < 1mm

-Varicose veins with CR12i or CR30i

catheter < 1-5 mm

-GSV/SSV with CR45i catheter

-Haemorrhoids with HPR45i probe

Changing the selection can be done by touching the button

By touching you go to the settings

screen.



5.1 Configuration of the EVRF

After touching the button in the mode selection screen you end up in the settings screen.

In this screen you have the option to alter 2 settings: language and screen contrast.

By touching one of the buttons you will be able to change the selected option.

By touching you go back to the

mode selection screen.

5.1.1 Language settings

If the "language setting" option was chosen we end up in the following screen.

Several languages can be selected: French – English - Italian – Spanish - Portuguese - Norwegian – Swedish - German - Dutch.

Choose the desired language with the up/down arrows and touch the language

you wish. Touch to cancel and return to

the settings selection.

5.1.2 Screen contrast

If "screen contrast" was chosen we enter the screen to change the contrast.

Choose the desired contrast settings

with the left/right arrows and touch to

accept. Touch to cancel and return

to the mode selection



5.2 Use of the EVRF

When we are in the mode selection screen we have the option to choose between four types of treatment: needle- , handset- , CR45i- or HPR45i based treatment .

5.2.1 Needle holder

The Power setting, standard on 8Watt, can

be decreased or increased between 5W and 15W. The duration of the impulse width (T pulse).

We can decrease or increase

the duration. The time between 2 pulses (T down). This

time can be decreased by touching

or increased by touching On the left we have a clock which indicates the duration of the treatment. On the left below we have a drawing of a foot pedal with a counter which will indicate the number of pulses given.

The OFF icon in the top left corner indicates that the EVRF is in “OFF” mode. By touching on “OFF” the EVRF is changed to “ON” and is ready to be used.

A beep indicates that the impulse is transmitted.

The beep stops as soon as the duration of the impulse is finished (ex: an impulse of 0.2 S will generate 2 sound beeps, an impulse of 0.4 S will generate 4 sound beeps).

If, after the first pulse is finished, the foot pedal is still activated then the “T Down” time starts. After T Down is finished and the foot pedal is still activated a new pulse will be transmitted. If you don’t want to use the “T Down” feature then you need to deactivate the pedal first before a new pulse will be transmitted.



5.2.2 CR12i & CR30i catheter

- The Power setting, standard on 14Watt,

can be decreased or increased

between 8W and 20W.

- Continuous mode. When the pedal is pressed the output is active until the pedal is released.

Joule:

-This is the sum of the amount of energy generated over a period of time.

The EVRF will give a sound beep every two seconds, so you know that every

beep, you have generated 2 times the watt that was set on the EVRF. This is the amount of joule that the EVRF generated.

When pressing the “OFF” button to put the machine in “ON” mode a pop-up will appear. The pop-up asks to confirm if the correct mode is selected and if the catheter is connected to the machine.

If the catheter connection is checked and the selected mode is correct then you can put the machine in “ON” mode

by pressing .

By pressing the machine remains in

“OFF” mode.



5.2.3 CR45i catheter :

- The Power setting, standard on

25Watt, can be decreased or

increased between 20W and 25W.

Continuous mode. When the pedal is pressed the output is active until the pedal is released.

Joule :

This is the sum of the amount of energy

generated over a period of time.

The EVRF will give a sound beep every two seconds, so you know that every beep, you have generated 2 times the watt that was set on the EVRF. This is the amount of joule that the EVRF generated.

When pressing the “OFF” button to put the machine in “ON” mode a pop-up will appear. The pop-up asks to confirm if the correct mode is selected and if the catheter & pad are connected to the machine.

If the catheter and pad connection is checked and the selected mode is correct then you can put the machine in

“ON” mode by pressing .


“OFF” mode.



5.2.4 Hemorrhoids





Joule :

-This is the sum of the amount of energy


The EVRF will give a sound beep every two seconds, so you know that every

beep, you have generated 2 times the watt that was set on the EVRF. This is the amount of joule that the EVRF generated.

When pressing the “OFF” button to put the machine in “ON” mode a pop-up will appear. The pop-up asks to confirm if the correct mode is selected and if the probe is connected to the machine.

If the probe connection is checked and the selected mode is correct then you can put the machine in “ON” mode by

pressing .


“OFF” mode.

5.2.5 End of the care

To stop the care definitively, one touches the button. We return to the basic screen.



6 TREATMENT PROTOCOLS

6.1 Needle holder

For the treatment of spider veins, rosacea and petechia the menu ‘Needle holder’ is used.

6.1.1 The equipment

The appliance is comprised of a generator with a programmer linked to a pedal and to a needle holder. There are two special needles for the removal of spider veins, rosacea and petechia:

The K3i needle with a diameter of 0.075mm which is mostly used for facial treatment

The K6i needle with a diameter of 0.150mm which is mostly used for the treatment of

legs

Quick user guide facial treatment

Diameter vein 0.3mm – 0.6mm

Treatment area Face

Needle K3i needle

Power (watt) 5 - 8

Max. 10

Impulse time 0.2 – 0.3 s

Quick user guide leg treatment

Diameter vein 0.7mm – 1.0mm

Treatment area Leg

Needle K6i needle

Power (watt) 9 - 14

Max. 16

Impulse time 0.3 – 0.4 s

Max. 0.5 s



6.1.2 Screen Needle holder

This screen indicates:

The Power setting, standard on 8Watt,


between 5W and 15W. The duration of the impulse width (T

pulse). We can decrease or

increase the duration. The time between 2 pulses (T down). This time can be decreased by touching

or increased by touching On the left we have a clock which indicates the duration of the treatment

and a drawing of a foot pedal with a counter which indicates the number of pulses given.

The OFF icon in the top left corner indicates that the EVRF is in “OFF” mode. By touching on “OFF” the EVRF is changed to “ON” and is ready to be used.

A beep indicates that the impulse is transmitted.

The beep stops as soon as the duration of the impulse is finished (ex: an impulse of 0.2 S will generate 2 sound beeps, an impulse of 0.4 S will generate 4 sound beeps).

If, after the first pulse is finished, the foot pedal is still activated then the “T Down” time starts. After T Down is finished and the foot pedal is still activated a new pulse will be transmitted. If you don’t want to use the “T Down” feature then you need to deactivate the pedal first before a new pulse will be transmitted.

End of the care

To stop the care definitively, one touches the button. We return to the basic screen

6.1.3 Treatment

The technique is simple but requires absolute rigour.

It is strongly recommended to follow the seven golden rules:

1. Press the needle perpendicular to the skin

2. The zone to be treated must be horizontal

3. Use a magnifying glass to avoid inserting the needle outside of the vessel

4. Clean the needle regularly with a sterile compress

5. Pulse every 1-2 mm

6. Work at a very superficial level

7. Use the appropriate diameter Ballet needle



6.1.4 Pragmatic approach

There are two adjustable parameters: the power of the wave and the emission duration. In general:

intensity: 5 – 14 watt

duration of emission: 0.2 s – 0.3 s

Systematic test before each pulse

Before sending the pulse, you must find the correct needle position by pressing on the varicosity with the needle until a small thread of varicosity disappears, confirming that you are properly positioned on the varicosity. The gentle pressure of the needle should make the varicosity disappear. At this moment, insert the needle very gently (still superficial) and send the pulse.

Verification of effectiveness

Immediately :

- pull the skin with both hands after treatment to see, using the magnifying-glass, if the varicosity has disappeared

- if the pulse was applied too lateral, the varicosity will reappear

- disappearance in itself is not a sufficient condition (because it is masked by the oedema) for the success of the treatment, but it is a necessary condition.

From day8 until day 15 :

- repeat the inspection.

- the space between the pulses must be pink and empty, indicating the disappearance of the varicosity.

Stage 1

red and blue varicosities < 0.3 mm (non catheterisable)

isolated

external leg of ankle

needle K3i

power setting 5 – 8 watt

pulse time 0.2 – 0.3 s

Remain at this stage during one month normally.

The result is 100% disappearance.

If certain varicosities have not disappeared, check that the effects of thermo coagulation are not found alongside the varicosity.

Stage 2

varicosities < 0.3 located in the knees and thighs

parameters identical to the first stage

During 15 days only do this and await the result.

This procedure is a little more delicate as these varicosities are often fed by a venule.



However, the correct technique should lead to a very positive result approaching 100%.

Stage 3

Six weeks after application of thermocoagulation, go on to stage 3

- isolated varicosities > 0.3 and < 0.6 mm; use K6i needle

- very good result

Stage 4

Varicosities > 0.3 grouped and fed by a reflux

More difficult to tackle - for the best result, it is preferable to treat the reflux first by using microsclerosis for example.

Evolution of the treatment

Normal evolution of the treatment

D 0: instantaneous disappearance of the varicosity with the appearance of an erythematous micro-oedema

D 8: appearance of very fine micro-scabs corresponding to the pulse points.

D 30: total disappearance

Abnormal evolution of the treatment

Disappearance of the oedema followed by reappearance of the varicosity over the days that follow.

The varicosity, in reality, has not been treated correctly and the oedema masked the result.

Pigmentation (always disappears)

Ochre marks of varying shades appearing a few days, or even a few weeks, after the treatment. These are associated with the use of non-insulated needles (more rarely) or a technical fault (the non-insulated part of the needle, the last millimetre, has been in contact with the skin), often following an overdose.

Transparent appearance of the skin (burn) - pulse too superficial

Dotted appearance: some of the varicosities were correctly treated (wait one month and then treat the remaining part).

How to avoid this problems

Lack of results

Strictly follow the protocol and the delay between each stage. This is often caused by a lateral insertion, alongside the varicosity. The great majority of cases are due to lateral pulse alongside the vessel. You must take time, carry out the tests, making sure you are in the vessel, send the pulse and use a magnifying-glass.

By small varicose veins, the capacity can be increased up to 12 watt, to ensure that the vein is closed.

If the varicose vein has a larger diameter, increase the power and the duration of the emission to 0.5 seconds.



Specificity of rosacea

The rosacea are a chronic and evolutionary skin trouble causing ignition and redness in the face. The cheeks and the nose are usually the first to become red, followed by redness of the face and chin.

The blotches can touch any person from 20-to-70-years, but the adults from 30-to-50-years having light and easily reddened skin are more often affected. Women are more prone to develop rosacea than men but the latter are more

inclined to develop a rhinophyma, which is a form of rosacea marked by redness, sebaceous hyperplasia and nodular swelling and congestion of the skin of the nose. It requires a surgical correction. Approximately 15 % of the population is affected.

Adjusting the parameters

power 5 – 8 watt

pulse time 0.2 s – 0.3 s

maximum number of pulses 300 / session

frequency of sessions: every 3 weeks

For a face 3 to 4 sessions are required.

Control after 8 weeks with maintenance once a year.

6.1.5 Contra-indications

Allergy to nickel and chromium (use a gold needle)

Pacemaker

Cutaneous infection

6.1.6 Advantage of Thermocoagulation

easy to use

instantaneous disappearance

allergies exceptional

no durable pigmentation

no necrosis

speed of treatment (session lasts a maximum of 10 to 15 minutes). For 300 to 400 pulses, in a single session we eradicate 80 to 100 cm of varicosities.

highly effective:

on all types of varicosities (small varicosities)

in all locations

on zones inaccessible to micro sclerosis (< to 0.3 mm).

on zones of the foot.

can be used on all types of skin.



6.1.7 Conclusion – Discussion

Micro sclerosis is currently the reference treatment for varicosities, but it does seem likely that phlebologists and other practitioners interested in this type of aesthetic damage will soon give preference to thermo coagulation.

Thermo coagulation, without the least danger, treats the same symptoms as micro sclerosis or laser therapy, but with superior results.

This therapy has been in use for 8 years. We have observed no recidivism in the patients monitored. It is very difficult to find parallel studies that demonstrate the effectiveness of micro sclerosis.

Secondary effects are virtually non-existent if we follow the seven golden rules.

Failures are rare.

6.2 CR12i & CR30i catheter

For the treatment of perforating, collateral and reticular veins the menu ‘CR12i & CR30i catheter’ is used.

6.2.1 The equipment

There are insertion needles for the CR12i & CR30i catheters. The catheters are manipulated with a sterilized handset and there is a connection cable to connect the catheter with the device.

Quick user guide CR12i

Diameter vein 1-2 mm

Catheter CR12i

Needle G24 needle

Power (watt) 9

Continuous mode Keep foot pedal pressed down

Number beeps at start 3

Number beeps per 8mm retraction 3

Connection of pad required Optional



Quick user guide CR30i

Diameter vein 2-5 mm

Catheter CR30i

Needle G20 needle

Power (watt) 16-19 watt


Number beeps at start 3

Number beeps per 8mm retraction 3

Connection of pad required Optional

6.2.2 Screen

The Power setting, standard on 14Watt,


between 8W and 20W.

- Continuous mode. When the pedal is pressed the output is active until the pedal is released.

Joule:

-This is the sum of the amount of energy generated over a period of time.

The EVRF will give a sound beep every two seconds, so you know that every beep, you have generated 2 times the

watt that was set on the EVRF. This is the amount of joule that the EVRF generated.

6.2.3 Treatment Step by step procedure

Preparation

Create a sterile or semi-sterile environment

Make sure that patient is not grounded or connected to any other radio frequency

device

The use of ultrasound is strongly recommended for deeper veins as well for the

superficial ones

Settings of EVRF device

Connect black cable to EVRF

Connect foot pedal to EVRF

Connect power cable to EVRF



Switch on generator, welcome screen appears and select “CR12i & CR30i catheter”

Use the following settings:

CR12i 9 watt

CR30i 15-19 watt

Finally connect CR12i or CR30i catheter to red cable and red cable to black cable

Introduction of 20 or 24 Gauge iv catheter

Puncture vein with 24G introducer (for the

CR12i catheter) or 20G introducer (for the CR30i

catheter) under ultrasound guidance

As soon as there is backflow, remove the

needle from the iv catheter

Introduction of CR12i or CR30i catheter

Place the hand piece on the iv catheter

Scroll the catheter into the vein



Follow the catheter with the ultrasound

Apply tumescence

The amount of applied tumescence differs according to the length of the treated vein.

A ratio of 20ml Xylocaine 2% to 500ml NaHCO3 1.4% is recommended

Apply tumescence under ultrasound guidance

and make sure liquid surrounds the catheter so

it will protect surrounding tissue and build up pressure

on the vein

Start the treatment

Make sure that catheter is connected to the

device and button on touch screen is switched “ON”

Put foot on pedal and give “continuous energy”

without removing foot from pedal

Every 2 beeps you hear a third high long beep.

At this point you retract the handpiece for 1 cm (6secs/1cm). Also LED lights on the

device will tell you when to retract: once light goes red, move catheter 1 cm

Apply pressure by hand or with the probe

of the ultrasound during the procedure

Continue this procedure until the end

IMPORTANT !

Keep your foot on the foot pedal

If you need to interrupt treatment, take your foot off pedal. When continuing, use the

same settings

Patient may not be grounded or connected to any other radio frequency device

Contraindication for patients with a pacemaker

Contraindication for pregnant women



6.3 CR45i catheter

For the treatment of the Saphena Magna the menu ‘CR45i catheter’ is used.

6.3.1 The equipment

For the treatment of the Saphena Magna a 3M pad a 6 French Introducer and the CR45i catheter with a 0.5 cm tip are used.

3M Pad

Quick user guide CR45i catheter

Diameter vein 6mm – 18mm

Catheter CR45i

Needle 6 French Introducer

Power (watt) 25


Number beeps at start 2 x 3

Number beeps per 0.5 cm retraction 3

Pad connection required Yes

6.3.2 Screen

The Power setting, standard on




Joule :

This is the sum of the amount of energy generated over a period of time.

The EVRF will give a sound beep every two seconds, so you know that

every beep, you have generated 2 times the watt that was set on the EVRF. This is the amount of joule that the EVRF generated.



6.3.3 Treatment Complete step by step procedure

Preparation

Create a sterile environment.

Make sure that patient is not grounded or connected to any other radio frequency

device!

Flush 6F” introducer.

Procedure must be performed under ultrasound guidance.

Settings of EVRF device

Connect black cable to EVRF.

Connect foot pedal to EVRF.

Connect power cable to EVRF.

Switch on generator, welcome screen appears and select “CR45i catheter:

Saphena.”

Use following settings:

Saphena Magna 25 Watt (from SF junction to knee)

• From knee to ankle, where the vein runs closer

to the skin surface, reduce wattage to 22 Watt.

Magna Parva 21-23 Watt

Perforating vein 20 Watt

Finally connect CR45i catheter to black cable.

Introduction of the 6F” sheath

Put patient in the anti-trendelenburg position

Puncture GSV with 6F introducer under ultrasound guidance.

As soon as there is backflow, enter guide wire.

Remove needle when guide wire is in place and position dilatator and sheath through

guide wire.

If necessary make a small incision as to assist entry of the sheath.

Remove guide wire and dilatator leaving sheath in position and flush vein with

Heparin water.



Introduction of CR45i catheter

Put patient in Trendelenburg position.

Insert CR45i catheter into sheath.

Push the catheter through the sheath within the vein under ultrasound guidance

Bend or stretch the leg if necessary to facilitate manipulating the catheter.

Check position of catheter tip with ultrasound system towards the femoral junction

(and move the catheter tip 1-2 cm away from the valve).

When catheter is in position, use the red rubber marker to hold it in place

Apply tumescent Anaesthesia

Ratio of tumescence during general and local anaesthesia: for each leg 500cc of

1,4%

bicarbonate,10cc of Xylocaine 2%.

Minimum usage per leg should be 250cc.

Apply the tumescent anaesthesia under ultrasound guidance and ensure that it

surrounds the catheter throughout its length so as to protect surrounding tissue

After applying the tumescence, recheck the position of the catheter to ensure it has

not moved

Start the treatment

Ensure that the catheter cable is firmly connected to the output cable

Using the palm of the finger, touch the OFF icon on the screen to switch to ON

Depress the foot pedal and keep it depressed throughout the treatment

Retract catheter according to markings on catheter, from white mark to black mark

(0.5cm).

The device emits three beeps, two short and one long

On the long beep, retract the catheter according to the markings along its length.

Each retraction should be no more than one marking, approximately 0,5 cm

The LED lights on the unit reflect the beeps (amber, green & red). Retraction should

occur on the red light. There are 3 triple markings along the length of the catheter.

When the first triple marking is revealed, release the foot pedal, slide/withdraw the

sheath completely along the catheter, holding the catheter in place and then continue

with the treatment. The next two triple markers will indicate when to end the treatment

and withdraw the catheter. When the first of these 2 markers are revealed, if the vein

is becoming superficial, then end the treatment there and remove the catheter. This is

to prevent burning the skin. If the vein is lying deeper, you can proceed until the final

marker reveals itself.



IMPORTANT!

- Always keep the foot pedal depressed whilst withdrawing the catheter.

- If the treatment needs to be interrupted, release the foot pedal. Simply depress the

foot pedal again when the treatment is to recommence.

- Always release the foot pedal before changing settings on the EVRF device and wait

2 seconds .

- Patient should not be grounded or connected to any other radio frequency device.

- Contraindications for patients who are pacemaker dependent. A cardiologist must

approve this treatment for patients with a pacemaker.

- Contraindications for pregnant women.

- Always place the patient in Trendelenburg position prior to treatment.

- Only authorised and suitably trained/qualified practitioners should attempt to use the

EVRF.

TIP

If the vein has a large diameter at the commencement of the treatment, it is recommended to

apply double cycles of energy. This means having to wait for the second long beep as it runs

through two cycles. Then retract at 0,5cm intervals as normal. Double cycles can be applied

for the first 2-3 cms (6 cycles) if necessary. If the vein becomes very superficial, by the knee

for example, it may be necessary to reduce the power in order to avoid burning through the

skin.



6.3.4 Set-up and use of EVRF pads



6.4 Hemorrhoids

For the treatment of hemorrhoids the menu ‘HPR45i’ is used.

6.4.1 The equipment

Degrees 2-4 of hemorrhoids are treated with the HPR45i probe.

Quick user guide

Hemorrhoids Degree II, III and IV

Probe HPR45i

Power (watt) 25 watt


Number beeps/location 9-12

Pad connection required No

6.4.2 Screen





Joule :

This is the sum of the amount of energy


The EVRF will give a sound beep every two seconds, so you know that every beep, you have generated 2

times the watt that was set on the EVRF. This is the amount of joule that the EVRF generated.



6.4.3 Treatment

For the treatment of hemorrhoids:

- The duration of one session for the treatment of hemorrhoids is about 15 minutes.

- The level of wattage used during this treatment is 25 watt.

- The total energy amounts an average of 3000 Joules per one session.

- Anaesthesia is a local 3-5ml 1% Lignocaine solution.

- For postoperative treatment Ketoprofen 2x1t 5% Lignocaine gel is used.

- The interval of sessions is 6 weeks.

- Possible side effects are increased tension of the anus or slimes in the anus during the first 2 weeks after treatment.

Complications!

Complications are very rare so some of them are “could be” complications.

1. Recurrences of an earlier treatment with laser, Bipolar diathermy or a surgical method. 2. Marginal Hematoma, marginal clot – single or multiple. Treatment with diosmin plus excision or incision plus evacuation. 3. Anal fissure : treatment with Dilzem 2% or botox, dilatator, hemagel. 4. Penetration of the muscle layer, surrounding tissue of the hemorrhoid or anal canal with the HPR45i creating a deep wound. Or applying energy in these areas for too long. Prolonged healing process. Treatment : dilatator, lidocaine ointment and hemagel.

To avoid unnecessary tissue damage with the insertion of the probe it’s important to administer anesthesia from the hemorrhoid base deep into de muscle layer. The fluid will separate the vessel layer and the muscle layer. Hold the HPR45i in the center of the intestine away from the muscle layer during the procedure. 5. Late Complications: Too much energy in the same area, energy could be distributed to the anal canal and might result in damaging the internal sphincter. This will take more time to heal. Sphincter damage leads to sphincter fibrosis and increased tension of the anal canal.

IMPORTANT!

Before the treatment they perform a rectoscopic analysis to look for serious diseases : rectal cancer(carcinoma) or polyps. The rectoscopy is not performed when the patient recently had a rectoscopy or colonoscopy.



6.5 EVRF Quick User Guide

These tables will give a clear overview of which settings are necessary for which vein treatment.



7 ANNUAL CONTROL FORMS

The EVRF must have an annual control to be able to claim with the maintenance of its MARKING EC. This control makes it possible to check all the functions of the apparatus and, particularly, the safety measures.

This chapter relates to the notebook of maintenance of the EVRF.

Control of end of guarantee

Date of control to carry out: Date of control :

Checks carried out:

- Visual monitoring and cleaning of EVRF.

- Security’s control.

- Control functions of orders.

- Measuring of the output signals.

- Control of the foot pedal.

- Control pen carries needle.

Changed components:

- Pen carried needle.

- Other components : ……………………………………………………………..

…………………………………………………………………………………………..

Name and visa of the controller Name and visa of the customer:



Control of year 2


Checks carried out:







Changed components:



…………………………………………………………………………………………..




Control of year 3


Checks carried out:







Changed components:



…………………………………………………………………………………………..




Control of year 4


Checks carried out:







Changed components:



…………………………………………………………………………………………..




Control of year 5


Checks carried out:







Changed components:



…………………………………………………………………………………………..




Control of year 6


Checks carried out:







Changed components:



…………………………………………………………………………………………..




8 Defect report form

This card must be returned to F care systems within 15 days after occurrance of a

problem with the EVRF

F care systems NV

Oosterveldlaan 99

B-2610 –WILRIJK-ANTWERP - Belgium

Fax: +32 3 451 51 39

Email: [email protected]

I, undersigned (name and function)............................................................ state that, when using EVRF N° : …………………………….. , on date ………………. to have experienced the following problem with the EVRF:

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NAME and SIGNATURE STAMP

Telephone number: ......................................................................................................

Email: ......................................................................................................
mailto:[email protected]

14 manual evrf e d - f care systems€¦ · manual thermocoagulation - evrf date 27/07/2015 page 3...

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