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MANUAL                                                                        THERMOCOAGULATION - EVRF 

 

Date  

26/06/2018 

Page 4 of 34 

Revision N° : 18 

 

Summary

 

1

 

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

 

1.1

 

E

LECTRICAL 

S

ECURITY

................................................................................................................................ 6

 

1.2

 

E

LECTROMAGNETIC DISRUPTION

 .................................................................................................................. 6

 

1.3

 

P

ROTECTION AGAINST EXPLOSION

 ................................................................................................................ 6

 

1.4

 

S

ECURITY BY INSTALLATION

 ......................................................................................................................... 6

 

1.5

 

S

ECURITY DURING  USE

 .............................................................................................................................. 7

 

1.6

 

T

ECHNICAL CONTROL

 ................................................................................................................................ 7

 

1.7

 

G

UARANTEE AND LIABILITIES

 ....................................................................................................................... 7

 

1.8

 

C

LEANING AND SERVICING

 .......................................................................................................................... 8

 

1.9

 

I

N CASE OF PROBLEMS

 ............................................................................................................................. 10

 

1.10

 

P

RACTICAL ADVICE

 ................................................................................................................................. 10

 

1.11

 

R

ESTRICTION STERILE CATHETERS

 ............................................................................................................... 10

 

2

 

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

 

2.1

 

G

ENERAL CHARACTERISTICS

 ...................................................................................................................... 11

 

2.2

 

E

XPLANATION OF THE 

S

YMBOLS

 ................................................................................................................. 11

 

2.3

 

O

UTPUT CHARACTERISTICS

 ....................................................................................................................... 12

 

2.4

 

L

ABEL EXPLANATION

 ............................................................................................................................... 12

 

2.5

 

F

UNCTIONING

 ....................................................................................................................................... 12

 

2.6

 

D

ECLARATION OF CONFORMITY

 ................................................................................................................. 13

 

3

 

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

 

3.1

 

S

PIDER VEINS AND 

T

ELANGIECTASIA

 ............................................................................................................ 14

 

3.2

 

V

ARICOSE VEINS

 .................................................................................................................................... 14

 

3.3

 

P

ERFORATING VEINS

 ............................................................................................................................... 14

 

3.4

 

S

APHENA PARVA AND SAPHENA MAGNA

....................................................................................................... 14

 

3.5

 

H

EMORRHOIDS

 ..................................................................................................................................... 14

 

3.6

 

C

ONTRA 

I

NDICATIONS

 ............................................................................................................................. 15

 

3.7

 

C

AUTION

 ............................................................................................................................................. 15

 

3.8

 

P

OSSIBLE SIDE EFFECTS AND COMPLICATIONS

 ................................................................................................ 16

 

3.9

 

I

MPORTANT

 .......................................................................................................................................... 16

 

4

 

DESCRIPTION OF THE EVRF AND THE ACCESSORIES ............................................................................... 17

 

4.1

 

F

RONT FACE OF THE 

EVRF ....................................................................................................................... 17

 

4.2

 

B

OTTOM SIDE OF THE 

EVRF ..................................................................................................................... 17

 

4.3

 

     

A

CCESSORIES

 ..................................................................................................................................... 17

 

4.3.1

 

Foot pedal

 .............................................................................................................................. 18

 

4.3.2

 

Output cable

........................................................................................................................... 18

 

4.3.3

 

3M cable

 ................................................................................................................................. 18

 

4.3.4

 

Needle-holder pen 

(with connection cable)

 ......................................................................... 18

 

4.3.5

 

Needles

 .................................................................................................................................. 19

 

4.3.6

 

CR30KAB catheter

 ................................................................................................................ 19

 

4.3.7

 

Insertion needles

 ................................................................................................................... 19

 

4.3.8

 

CR40i catheter

 ....................................................................................................................... 20

 

4.3.9

 

CR45i catheter and 6 French Introducer

 ............................................................................. 20

 

4.3.10

 

The 3M Pad

 ........................................................................................................................... 20

 

4.3.11

 

HPR45i probe

 ........................................................................................................................ 20

 

5

 

USE OF THE EVRF SYSTEM ..................................................................................................................... 21

 

5.1

 

C

ONFIGURATION OF THE 

EVRF ................................................................................................................. 22

 

5.1.1

 

Language settings

 ................................................................................................................. 22

 

5.1.2

 

Screen contrast

 ..................................................................................................................... 22

 

5.2

 

U

SE OF THE 

EVRF .................................................................................................................................. 23

 

5.2.1

 

Needle holder

 ........................................................................................................................ 23

 

Содержание EVRF

Страница 1: ...THERMOCOAGULATION EVRF Date 26 06 2018 Page 1 of 34 Revision N 18 MANUAL EVRF D Mue EVRF 18 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 ...

Страница 2: ...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 QUALIF...

Страница 3: ...ption 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 ...

Страница 4: ...ION FOR USE 14 3 1 SPIDER VEINS AND TELANGIECTASIA 14 3 2 VARICOSE VEINS 14 3 3 PERFORATING VEINS 14 3 4 SAPHENA PARVA AND SAPHENA MAGNA 14 3 5 HEMORRHOIDS 14 3 6 CONTRA INDICATIONS 15 3 7 CAUTION 15 3 8 POSSIBLE SIDE EFFECTS AND COMPLICATIONS 16 3 9 IMPORTANT 16 4 DESCRIPTION OF THE EVRF AND THE ACCESSORIES 17 4 1 FRONT FACE OF THE EVRF 17 4 2 BOTTOM SIDE OF THE EVRF 17 4 3 ACCESSORIES 17 4 3 1 F...

Страница 5: ...VRF Date 26 06 2018 Page 5 of 34 Revision N 18 5 2 2 CR30KAB catheter 24 5 2 3 CR45i catheter 24 5 2 4 Hemorrhoids 25 5 3 ERROR AT START UP 26 5 4 SET UP AND USE OF EVRF PADS 27 6 ANNUAL CONTROL FORMS 28 7 DEFECT REPORT FORM 34 ...

Страница 6: ...ruption 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...

Страница 7: ...ectual people People who can t express themselves or reveal abnormal sensations infants elderly People with epilepsy heart failure pregnancy People who refuse the treatment See also chapter contra indications 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 consi...

Страница 8: ... 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 1 7 1 3 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 e...

Страница 9: ... 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 MANUF...

Страница 10: ... 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 workin...

Страница 11: ...st liquid penetration IPX0 Temporized fuse in glass Work in continuous Dimensions W 360 mm D 280 mm H 120 mm Weight 5 Kg Class IIb apparatus Insulation class I Output of the thermo coagulation HF signal Fuse reference 2x F2A 250V Switch on Switch off button 2 2 Explanation of the Symbols Confirm Cancel Navigate Reduce power Increase power Reduce impuls Increase impuls Switch between ON OFF state S...

Страница 12: ...tage in output 660V Max time of impulse 0 8s 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 cond...

Страница 13: ...hena parva Product name EVRF Has been classified as Class IIb according to annex IX rule 9 of the Medical Device Directive93 42 EECand 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 1041 2008 A1 2013 EN 60601 1 2006 AC 2010 EN ISO 14971 2012 EN 60601 1 2 200...

Страница 14: ...the muscles contract The resulting reflux can cause a rapid deterioration in an existing varicose disease and be responsible for the development of venous ulcers 3 4 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 light...

Страница 15: ...ngo treatment and patients with bleeding disorders 3 7 Caution The following precautions need to be taken for each type of treatment Patient may not be grounded or connected to any other radio frequency 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...

Страница 16: ...ema Slime forming Thrombose Anal fissure Fever Strong pain Incontinence to flatus Hypersensitivity to metal stainless steel type AISI316L Chronic delayed wound healing Following hemorrhoid treatment complications are unlikely but cannot be ruled out Urinary retention Skin tag formation Increased tension of the anus Marginal hematoma Marginal clot single or multiple Late Complications Too much ener...

Страница 17: ...F 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 For the correct functioning of the EVRF accessories are required Attention use of accessories and cables other than those provided by F Care Systems could result in malfunctioning of the EVRF The accessories of the EVRF are the following ...

Страница 18: ...tput cable Cable used to connect the apparatus to the needle holder or catheter CR30KAB 4 3 3 3M cable Cable used to connect the neutral electrode 3M pad to the apparatus 4 3 4 Needle holder pen with connection cable To be used in combination with the sterile K3i or K6i needles When linked to the apparatus it permits to transmit the high frequency impulses through the needle for treatment of telan...

Страница 19: ... 3 6 CR30KABi catheter Reticular collateral and perforating veins can be treated with F Care Systems CR30KAB catheter The catheter is extremely flexible so that they follow the direction of the vein easily Smooth insertion is ensured with the advanced coating material around the catheter The non insulated tip transmits the high frequency signal to the vein wall This causes the vein to coagulate an...

Страница 20: ...ch 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 10 The 3M Pad The neutral electrode i...

Страница 21: ...me screen is shown while the EVRF is testing the different programs In case a problem is found with one of the possible programs a warning screen is shown see chapter 5 3 If all programs are functioning correctly then the program selection screen is shown In this menu you have the option to choose between 4 modes Telangiectasia with needle holder 1mm Varicose veins with CR30KAB catheter 1 5 mm GSV...

Страница 22: ... 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 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 chose...

Страница 23: ...ber 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 pul...

Страница 24: ...d When pressing the OFF button the device will check if the output cable is connected If the cable is not connected a beep is given and the device remains in OFF mode If the output cable is connected then a pop up screen is shown with the status of the pad When you accept the pop up then the device will be place in ON mode If the pop up is declined then the device remains in OFF mode You can also ...

Страница 25: ...Watt 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 ...

Страница 26: ...art up a warning screen is shown and the defective program is locked to prevent usage When trying to enter the program the machine will show a warning screen explaining that the program is locked and that the device needs to be revised Only the programs in which a problem was found are locked other programs can still be used safely ...

Страница 27: ...MANUAL THERMOCOAGULATION EVRF Date 26 06 2018 Page 27 of 34 Revision N 18 5 4 Set up and use of EVRF pads ...

Страница 28: ...of the device is tested This chapter relates to the notebook of maintenance of the EVRF Control at end of guarantee Date of control to carry out Date of control Checks carried out Visual check of EVRF Security control Control functions of orders Measuring of the output signals Control of the foot pedal Control of needle holder Control of output cables Changed components Needle holder Output cable ...

Страница 29: ...of control Checks carried out Visual check of EVRF Security control Control functions of orders Measuring of the output signals Control of the foot pedal Control of needle holder Control of output cables Changed components Needle holder Output cable Other components Name and visa of the controller Name and visa of the customer ...

Страница 30: ...of control Checks carried out Visual check of EVRF Security control Control functions of orders Measuring of the output signals Control of the foot pedal Control of needle holder Control of output cables Changed components Needle holder Output cable Other components Name and visa of the controller Name and visa of the customer ...

Страница 31: ...of control Checks carried out Visual check of EVRF Security control Control functions of orders Measuring of the output signals Control of the foot pedal Control of needle holder Control of output cables Changed components Needle holder Output cable Other components Name and visa of the controller Name and visa of the customer ...

Страница 32: ...of control Checks carried out Visual check of EVRF Security control Control functions of orders Measuring of the output signals Control of the foot pedal Control of needle holder Control of output cables Changed components Needle holder Output cable Other components Name and visa of the controller Name and visa of the customer ...

Страница 33: ...of control Checks carried out Visual check of EVRF Security control Control functions of orders Measuring of the output signals Control of the foot pedal Control of needle holder Control of output cables Changed components Needle holder Output cable Other components Name and visa of the controller Name and visa of the customer ...

Страница 34: ...thin 15 days after occurrence of a problem with the EVRF F Care Systems NV Oosterveldlaan 99 B 2610 WILRIJK ANTWERP Belgium Fax 32 3 451 51 39 Email Info fcaresystems com I undersigned name and function state that when using EVRF N on date to have experienced the following problem with the EVRF NAME and SIGNATURE STAMP Telephone number Email ...

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