MANUAL EVRF. D.Mue.EVRF.18 THERMOCOAGULATION - EVRF

Transcription

1 D.Mue.EVRF.18 MANUAL EVRF F CARE SYSTEMS NV Oosterveldlaan 99 B Antwerp - Belgium TEL: FAX: Date 26/06/ Page 1 of 34 Revision N : 18

2 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. Date 26/06/2018 Page 2 of 34 Revision N : 18

3 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 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 Date 26/06/2018 Page 3 of 34 Revision N : 18

4 Summary 1 SECURITY INSTRUCTIONS ELECTRICAL SECURITY ELECTROMAGNETIC DISRUPTION PROTECTION AGAINST EXPLOSION SECURITY BY INSTALLATION SECURITY DURING USE TECHNICAL CONTROL GUARANTEE AND LIABILITIES CLEANING AND SERVICING IN CASE OF PROBLEMS PRACTICAL ADVICE RESTRICTION STERILE CATHETERS TECHNICAL CHARACTERISTICS GENERAL CHARACTERISTICS EXPLANATION OF THE SYMBOLS OUTPUT CHARACTERISTICS LABEL EXPLANATION FUNCTIONING DECLARATION OF CONFORMITY INDICATION FOR USE SPIDER VEINS AND TELANGIECTASIA VARICOSE VEINS PERFORATING VEINS SAPHENA PARVA AND SAPHENA MAGNA HEMORRHOIDS CONTRA INDICATIONS CAUTION POSSIBLE SIDE EFFECTS AND COMPLICATIONS IMPORTANT DESCRIPTION OF THE EVRF AND THE ACCESSORIES FRONT FACE OF THE EVRF BOTTOM SIDE OF THE EVRF ACCESSORIES Foot pedal Output cable M cable Needle-holder pen (with connection cable) Needles CR30KAB catheter Insertion needles CR40i catheter CR45i catheter and 6 French Introducer The 3M Pad HPR45i probe USE OF THE EVRF SYSTEM CONFIGURATION OF THE EVRF Language settings Screen contrast USE OF THE EVRF Needle holder Date 26/06/2018 Page 4 of 34 Revision N : 18

5 5.2.2 CR30KAB catheter CR45i catheter: Hemorrhoids ERROR AT START-UP SET-UP AND USE OF EVRF PADS ANNUAL CONTROL FORMS DEFECT REPORT FORM Date 26/06/2018 Page 5 of 34 Revision N : 18

6 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 a power 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. Date 26/06/2018 Page 6 of 34 Revision N : 18

7 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, nonintellectual 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 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. Date 26/06/2018 Page 7 of 34 Revision N : 18

8 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. Date 26/06/2018 Page 8 of 34 Revision N : 18

9 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, catheters and probes are sterile and for single use. Never use the same needle, catheter or probe for more than one patient and wear gloves during the treatment. Reusing or re-sterilizing the needles, catheters or probes 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 Maintenance 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. 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. After 15 weeks the device must pass the procedure test again. Date 26/06/2018 Page 9 of 34 Revision N : 18

10 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 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. When applied, the entire area of neutral electrode/pad 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 Restriction sterile catheters The following restrictions are applicable for the sterile accessories: - 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). Date 26/06/2018 Page 10 of 34 Revision N : 18

11 2 TECHNICAL CHARACTERISTICS 2.1 General characteristics Supply Voltage: V / 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. Weight: +/- 5 Kg. Class IIb apparatus. Insulation: class I.! Output of the thermo-coagulation (HF) signal. Fuse reference: 2x F2A / 250V. 0 1 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. Session timer. Date 26/06/2018 Page 11 of 34 Revision N : 18

12 The number of impulse per session. Type BF device. CE marking. Read manual before use. U FREQ P Allowed voltage. Frequency. 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 : 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%, condensation comprised. Atmospheric pressure comprised between 700 hpa and 1060 hpa. The power supply cannot exceed a voltage of 230V~+-10% of the rated voltage. Date 26/06/2018 Page 12 of 34 Revision N : 18

13 2.6 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: Thermo-coagulator 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/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 :2006/AC:2010 EN ISO :2012 EN : 2007 EN ISO :2016 EN : A11 (2012) EN 62304:2006/AC:2008 EN 62366:2015 and is subject to the procedure set out in Annex II of the Council Directive 93/42/EC. This declaration is made on base of quality assurance certificate. N BE 10/ Delivered by SGS Belgium, N 1639 Signed : Name: Rudi Devers. Function: Managing Director. Date 26/06/2018 Page 13 of 34 Revision N : 18

14 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 CR30KAB catheter. This catheter can be inserted into a varicose vein through a 20 gauge access needle. The catheter is 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 CR30KAB allows the coagulation of varicose veins with a diameter of about 2 to 5mm. 3.3 Perforating veins When the valves of perforator veins become incompetent they can cause venous reflux when 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 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. 3.5 Hemorrhoids The EVRF has a connection to the HPR45i probe, which is a small stiff probe with a noninsulated 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. Date 26/06/2018 Page 14 of 34 Revision N : 18

15 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. - Obstructed deep venous system. - Deep vein thrombosis. - Allergic to substances in tumescence. For hemorrhoid treatment - Cutaneous infection. - Anal fissures. - Infective anal pathologies like cryptitis & proctitis. - Allergic to substances in tumescence. - Presence of stitches from previous Longo 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 treating patients who suffer from hyper coagulopathy. For treatment of varicose veins precautions need to be taken when treating patients with following conditions: - Congenital vasculopathies. - Thrombophilia. - Sciatic vein reflux. - Occlusive peripheral arterial disease. For treatment of hemorrhoids the following precautions are additional: - Always work above the dentate line. - Patients who have had Longo treatment require a radioscopy to detect remaining stitches. Date 26/06/2018 Page 15 of 34 Revision N : 18

16 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. - Ecchymosis. - Paresthesia. - Puncture site infection. - Scar. - Periphlebitis. - Induration. - Edema. - Bruising. - Hypersensitivity to metal (stainless steel type AISI316L) Hemorrhoid treatment - Bleeding (including mild serosanguinous discharge). - Edema. - 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 energy in the same area, energy could be distributed to the anal canal and might result in damaging the internal sphincter. 3.9 Important Before treatment of varicose veins can be performed it should be checked if the deep vein system functions correctly. Patients should avoid exposure to sunlight until all bruising and redness has disappeared to avoid hyperpigmentation. Date 26/06/2018 Page 16 of 34 Revision N : 18

17 Before the treatment of hemorrhoids, it is advised to perform a rectoscopy analysis to look for serious diseases: rectal cancer(carcinoma) or polyps. If the patient recently had a rectoscopy or colonoscopy, then another rectoscopy analysis is not required. 4 DESCRIPTION OF THE EVRF AND THE ACCESSORIES 4.1 Front face of the EVRF 1. Display with touchscreen. 2. Connection for the 3M cable (black). 3. Connection for the output cable (red). 4. Connection for the foot pedal (blue). 4.2 Bottom side of the EVRF 2 1. Main power supply + fuse holder + ON/OFF Switch. 2. Cooling fan 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: Date 26/06/2018 Page 17 of 34 Revision N : 18

18 4.3.1 Foot pedal The foot pedal permits to activate the high frequency impulses. It connects the blue connector with the EVRF Output cable Cable used to connect the apparatus to the needle holder or catheter CR30KAB M cable Cable used to connect the neutral electrode (3M pad) to the apparatus 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 telangiectasia. Date 26/06/2018 Page 18 of 34 Revision N : 18

19 4.3.5 Needles The apparatus is delivered with a set of Ballet needles. The needles are available in 2sizes, Ballet K3i (0,075 mm) and Ballet K6i (0,150 mm), and are made out of chromium and nickel material. In case the patient has a Nickel or Chromium allergy do not use these needles, see chapter contra indications. The needles are marked CE0459 conform to the Directive 93/42/CEE. The needles are single use and must be used before their expiry date 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 and eventually disappear 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. Insertion needles for CR30KAB Date 26/06/2018 Page 19 of 34 Revision N : 18

20 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. Smooth and fast insertion is ensured by the advanced coating material around the flexible core. The markings allow for easy positioning during pull-back 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 The 3M Pad The neutral electrode is to be used when working with a catheter type CR45i. The neutral electrode is attached to the patient. 3M Pad The entire area of neutral electrode/pad should be reliably attached to a suitably prepared and appropriate area of the patients body. We recommend the lower back, shoulder or buttocks area HPR45i probe With the HPR45i probe hemorrhoids degree 2-4 can be treated easily and effectively. Date 26/06/2018 Page 20 of 34 Revision N : 18

21 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). Switch on the apparatus, the welcome screen appears. The welcome 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/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. Date 26/06/2018 Page 21 of 34 Revision N : 18

22 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. 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 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 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. Date 26/06/2018 Page 22 of 34 Revision N : 18

23 5.2 Use of the EVRF When we are in the program selection screen we have the option to enter the Needle holder treatment screen or to enter the Scan screen Needle holder The Power setting, standard on 8Watt, can be decreased between 5W and 15W. or increased 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 is transmitted. 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. Date 26/06/2018 Page 23 of 34 Revision N : 18

24 5.2.2 CR30KAB catheter - The Power setting, standard on 16Watt, can be decreased between 8W and 25W. or increased - Continuous mode. When the pedal is pressed the output is active until the pedal is released. - logo Indication of whether or not the pad is connected. 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 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 leave the program and return to the program selection by pressing CR45i catheter: - The Power setting, standard on 25Watt, can be decreased between 20W and 25W. or increased Continuous mode. When the pedal is pressed the output is active until the pedal is released. LOGO Indication of whether or not the pad is connected. Joule: This is the sum of the amount of energy generated over a period of time. Date 26/06/2018 Page 24 of 34 Revision N : 18

25 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 Hemorrhoids 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 leave the program and return to the program selection by pressing. - The Power setting, standard on 25Watt, can be decreased increased 25W. between 20W and or 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 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. The device will also check if the pad is connected. If the pad is connected, then a warning will be shown advising to disconnect the pad. If the pad is not connected, then no message is shown and the device is placed in ON mode. You can also leave the program and return to the program selection by pressing. End of the care. To stop the care definitively, one touches the button. We return to the basic screen. Date 26/06/2018 Page 25 of 34 Revision N : 18

26 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. Only the programs in which a problem was found are locked, other programs can still be used safely. Date 26/06/2018 Page 26 of 34 Revision N : 18

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

28 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. 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. Other components: Name and visa of the controller Name and visa of the customer: Date 26/06/2018 Page 28 of 34 Revision N : 18

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. Control of needle holder. Control of output cables. Changed components: Needle holder. Output cable. Name and visa of the controller Name and visa of the customer: Date 26/06/2018 Page 29 of 34 Revision N : 18

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. Control of needle holder. Control of output cables. Changed components: Needle holder. Output cable. Name and visa of the controller Name and visa of the customer: Date 26/06/2018 Page 30 of 34 Revision N : 18

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. Control of needle holder. Control of output cables. Changed components: Needle holder. Output cable. Name and visa of the controller Name and visa of the customer: Date 26/06/2018 Page 31 of 34 Revision N : 18

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. Control of needle holder. Control of output cables. Changed components: Needle holder. Output cable. Name and visa of the controller Name and visa of the customer: Date 26/06/2018 Page 32 of 34 Revision N : 18

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. Control of needle holder. Control of output cables. Changed components: Needle holder. Output cable. Name and visa of the controller Name and visa of the customer: Date 26/06/2018 Page 33 of 34 Revision N : 18

34 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: 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: Date 26/06/2018 Page 34 of 34 Revision N : 18