F Care Systems EVRF Manual
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F Care Systems EVRF Manual

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MANUAL
MANUAL EVRF
Date 26/06/2018
F CARE SYSTEMS NV
Oosterveldlaan 99
B-2610 - Antwerp - Belgium
TEL: +32 3 451 51 45
FAX: +32 3 451 51 39
Page 1 of 34
WWW.FCARESYSTEMS.COM
THERMOCOAGULATION - EVRF
Revision N° : 18

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  • Page 1 MANUAL THERMOCOAGULATION - EVRF MANUAL EVRF F CARE SYSTEMS NV Oosterveldlaan 99 B-2610 - Antwerp - Belgium TEL: +32 3 451 51 45 FAX: +32 3 451 51 39 Date 26/06/2018 Page 1 of 34 Revision N° : 18 WWW.FCARESYSTEMS.COM...
  • Page 2 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.
  • Page 3 MANUAL THERMOCOAGULATION - EVRF 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: ************************** *********. ……...

  • Page 4: Table Of Contents

    NDICATIONS ............................. 15 AUTION ....................16 OSSIBLE SIDE EFFECTS AND COMPLICATIONS ............................16 MPORTANT DESCRIPTION OF THE EVRF AND THE ACCESSORIES ................17 EVRF ........................17 RONT FACE OF THE EVRF ........................17 OTTOM SIDE OF THE ............................. 17 CCESSORIES 4.3.1...
  • Page 5 MANUAL THERMOCOAGULATION - EVRF 5.2.2 CR30KAB catheter ........................ 24 CR45i catheter: ........................24 5.2.3 5.2.4 Hemorrhoids .......................... 25 ..........................26 RROR AT START EVRF ........................ 27 UP AND USE OF PADS ANNUAL CONTROL FORMS........................28 DEFECT REPORT FORM .......................... 34...

  • Page 6: Security Instructions

    MANUAL THERMOCOAGULATION - EVRF 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.

  • Page 7: Security During Use

    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.

  • Page 8: Cleaning And Servicing

    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 eventual consequences for the device, the user or the patient;...
  • Page 9 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 –...

  • Page 10: In Case Of Problems

    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).

  • Page 11: Technical Characteristics

    MANUAL THERMOCOAGULATION - EVRF 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 : W = 360 mm, D = 280 mm, H = 120 mm.

  • Page 12: Output Characteristics

    MANUAL THERMOCOAGULATION - EVRF The number of impulse per session. Type BF device. CE marking. Read manual before use. Allowed voltage. FREQ Frequency. Maximum power. 2.3 Output characteristics This apparatus generates some high frequencies impulses whose characteristics are: Frequency of the wave : 4 MHz.

  • Page 13: Declaration Of Conformity

    MANUAL THERMOCOAGULATION - EVRF 2.6 Declaration of conformity DECLARATION OF CONFORMITY 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: Thermo-coagulator using radiofrequency ablation intended for...

  • Page 14: Indication For Use

    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.

  • Page 15: Contra Indications

    MANUAL THERMOCOAGULATION - EVRF 3.6 Contra Indications For all types of treatment People with heart disease including pace maker. Pregnant patients, including breastfeeding. Patients younger than 18 years. Contraindication to local anesthetic. For spider vein treatment Allergy to nickel. For varicose vein treatment Deep venous insufficiency.

  • Page 16: Possible Side Effects And Complications

    MANUAL THERMOCOAGULATION - EVRF 3.8 Possible side effects and complications Following side effects and complications can be experienced during or after the treatment. Spider vein treatment Pain Skin pigmentation Skin burn Varicose vein treatment Skin hyperpigmentation. Skin burns. Saphenous nerve damage.

  • Page 17: Description Of The Evrf And The Accessories

    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:...

  • Page 18: Foot Pedal

    THERMOCOAGULATION - EVRF 4.3.1 Foot pedal The foot pedal permits to activate the high frequency impulses. It connects the blue connector with the EVRF. 4.3.2 Output cable Cable used to connect the apparatus to the needle holder or catheter CR30KAB.

  • Page 19: Needles

    The needles are single use and must be used before their expiry date. 4.3.6 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.

  • Page 20: Cr40I Catheter

    MANUAL THERMOCOAGULATION - EVRF 4.3.8 CR40i catheter For the treatment of perforating veins, the CR40i catheter can be used. The catheter can be inserted in the vein for up to 25cm. Thermocoagulation of the perforating veins is performed with a 0,5 cm long tip, which is pulled back slowly so the entire vein closes.

  • Page 21: Use Of The Evrf System

    THERMOCOAGULATION - EVRF 5 USE OF THE EVRF SYSTEM The use of the EVRF is very easy. Connect the foot pedal to the apparatus (blue plug). If needed connect the non-sterile output cable to the device (only required for needle holder CR30KAB treatment).

  • Page 22: Configuration Of The Evrf

    MANUAL THERMOCOAGULATION - EVRF 5.1 Configuration of the EVRF After touching the button in the program selection screen you end up in the settings screen. In this screen you have the option to alter 2 settings: language and screen contrast.

  • Page 23: Use Of The Evrf

    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.

  • Page 24: Cr30Kab Catheter

    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.

  • Page 25: Hemorrhoids

    THERMOCOAGULATION - EVRF 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.

  • Page 26: Error At Start-Up

    MANUAL THERMOCOAGULATION - EVRF 5.3 Error at start-up When a problem is detected during start-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.

  • Page 27: Set-Up And Use Of Evrf Pads

    MANUAL THERMOCOAGULATION - EVRF 5.4 Set-up and use of EVRF pads Date 26/06/2018 Page 27 of 34 Revision N° : 18...

  • Page 28: Annual Control Forms

    THERMOCOAGULATION - EVRF 6 ANNUAL CONTROL FORMS The EVRF must be submitted to an annual control for it to be in conformance with its CE marking. During this control all the functions of the apparatus and, particularly, the safety of the device is tested.
  • Page 29 Control of year 2 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.
  • Page 30 Control of year 3 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.
  • Page 31 Control of year 4 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.
  • Page 32 Control of year 5 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.
  • Page 33 Control of year 6 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.

  • Page 34: Defect Report Form

    MANUAL THERMOCOAGULATION - EVRF 7 Defect report form This card must be returned to F CARE SYSTEMS within 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...

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