EN NOTES ON USE FiAPC probes 20132-220, 20132-221, 20132-222, 20132-223, 20132-224, 20132-225, 20132-226 OBJ_DOKU-184381-013.fm Seite 23 Dienstag, 13. Dezember 2022 2:13 14
24 Table of Contents 1 General instructions for use . . . . . . . . . . . . . . . . . . . . . . . 25 1.1 Intended use / Indications for use . . . . . . . . . . . . . . . 25 1.2 Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 1.3 Intended patient population . . . . . . . . . . . . . . . . . . . . 25 1.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 1.5 Single-use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 1.6 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 1.7 Qualification of user . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 1.8 Performance characteristics . . . . . . . . . . . . . . . . . . . . 26 2 Maximum electrical capacity and unit setting . . . . . . . . . 26 3 Required accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 4 Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 5 How to use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 5.1 Checking the expiration date. . . . . . . . . . . . . . . . . . . . 36 5.2 Checking and opening the packaging. . . . . . . . . . . . . 36 5.3 Checking the product . . . . . . . . . . . . . . . . . . . . . . . . . . 36 5.4 Connecting the product and selecting unit settings . . 36 5.5 Selecting the endoscope . . . . . . . . . . . . . . . . . . . . . . . 39 5.6 Using the product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 7 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 OBJ_DOKU-184381-013.fm Seite 24 Dienstag, 13. Dezember 2022 2:13 14
25 1 General instructions for use These notes on use describe the normal use of the product. Please read all information carefully. These notes on use do not replace the user manual of the APC unit used! Read the user manual of the APC unit and ask Erbe or your distributor in case of doubt! Note: Report serious incidents with the product to your local dealer or Erbe. If you are a user in the European Union, also report incidents to the responsible authority in your Member State. 1.1 Intended use / Indications for use The flexible FiAPC probes (Fi = with integrated filter) are intended for argon-plasma coagulation. 1.2 Compatibility The flexible FiAPC probes are compatible with the following units: • Erbe APC 300 with ICC series • Erbe APC 2 with VIO series • Erbe APC 3 with VIO 3 1.3 Intended patient population No restrictions. 1.4 Contraindications No known contraindications. OBJ_DOKU-184381-013.fm Seite 25 Dienstag, 13. Dezember 2022 2:13 14
26 1.5 Single-use The product is intended for single use. The product is supplied sterile. 1.6 Environment For the intended use, the product may only be operated in premises used for medical purposes. 1.7 Qualification of user For the intended use, the product may only be operated by medical professionals who have been trained in its use on the basis of the notes on use. 1.8 Performance characteristics Performance characteristics relating to the intended use are: • Conducting high-frequency current from the connector to the distal end. • Passing argon gas from the connector to the distal end. 2 Maximum electrical capacity and unit setting WARNING! Risk of injury due to probes being operated using unsuitable modes and/or power settings! It is essential that the settings recommended in this chapter are observed for the electrosurgical unit used. OBJ_DOKU-184381-013.fm Seite 26 Dienstag, 13. Dezember 2022 2:13 14
27 2.1 Probes with axial argon beam 20132-220: FiAPC probe 1500 A, single use, with filter Diameter 1.5 mm Length 1.5 m Required diameter of endoscope working channel > 1.8 mm Type of beam (A)xial Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 1.0 liter per minute ICC unit setting SPRAY COAG Mode, Power limitation 50 W max. VIO unit setting Automatic 20132-221: FiAPC probe 2200 A, single use, with filter Diameter 2.3 mm Length 2.2 m Required diameter of endoscope working channel > 2.5 mm Type of beam (A)xial Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 2.4 liter per minute ICC unit setting SPRAY COAG Mode, Power limitation 90 W max. VIO unit setting Automatic OBJ_DOKU-184381-013.fm Seite 27 Dienstag, 13. Dezember 2022 2:13 14
28 20132-222: FiAPC probe 2200 A, single use, with filter Diameter 3.2 mm Length 2.2 m Required diameter of endoscope working channel > 3.5 mm Type of beam (A)xial Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 5 liter per minute Note: When using an adapter, the gas flow is limited to 2.4 liters per minute. ICC unit setting SPRAY COAG Mode, Power limitation 120 W max. VIO unit setting Automatic 20132-223: FiAPC probe 3000 A, single use, with filter Diameter 2.3 mm Length 3.0 m Required diameter of endoscope working channel > 2.5 mm Type of beam (A)xial Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 2.4 liter per minute ICC unit setting SPRAY COAG Mode, Power limitation 90 W max. VIO unit setting Automatic OBJ_DOKU-184381-013.fm Seite 28 Dienstag, 13. Dezember 2022 2:13 14
29 2.2 Probes with lateral argon beam, so-called SideFire probes 20132-226: FiAPC probe 3000 A, single use, with filter Diameter 1.5 mm Length 3.0 m Required diameter of endoscope working channel > 1.8 mm Type of beam (A)xial Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 1.0 liter per minute ICC unit setting SPRAY COAG Mode, Power limitation 50 W max. VIO unit setting Automatic 20132-224: FiAPC probe 2200 SC, single use, with filter Diameter 2.3 mm Length 2.2 m Required diameter of endoscope working channel > 2.5 mm Type of beam (S)ide-Fire with (C)onical Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 2.4 liter per minute ICC unit setting SPRAY COAG Mode, Power limitation 90 W max. VIO unit setting Automatic OBJ_DOKU-184381-013.fm Seite 29 Dienstag, 13. Dezember 2022 2:13 14
30 2.3 Probes with circumferential argon beam 3 Required accessories IMPORTANT! The APC units are equipped with different APC sockets. Depending on the type of socket, you may or may not need an adapter to connect the probe. 20132-225: FiAPC probe 2200 C, single use, with filter Diameter 2.3 mm Length 2.2 m Required diameter of endoscope working channel > 2.5 mm Type of beam (C)ircumferential Beam Max. electrical capacity 5000 Vp Permissible gas flow Max. 2.4 liter per minute ICC unit setting SPRAY COAG Mode, Power limitation 90 W max. VIO unit setting Automatic Socket type Accessories for connecting the probe Adapter Art. No. 20132-227 No further accessories required. OBJ_DOKU-184381-013.fm Seite 30 Dienstag, 13. Dezember 2022 2:13 14
31 WARNING! 4 Safety instructions 4.1 Sterile product for single use The product must not be processed. Processing can affect the material properties and/or function of the product such that application in accordance with the intended use is no longer possible. It also cannot be ensured that the product will be sterile after processing. Risks include: • Components/connections that are damaged by high temperatures (e.g. in the autoclave). • Component geometries that prevent processing (e.g., inaccessible gaps, narrow lumens). 4.2 General information about protection of the user, patient, and product Do not use in the presence of combustible or explosive materials! In the case of a long activation time and/or activations which follow in quick succession (with no cooling time) the distal instrument end can become extremely hot. This is not a material fault, rather a consequence of heavy-duty use. Protect this product from any form of mechanical damage! Do not throw! Do not use force! If there is a cable, and unless stated otherwise, do not kink it or wrap it around the accompanying product! The activated electrosurgical unit can impair the performance of or damage cardiac pacemakers, internal defibrillators and other active implants. In the case of patients wearing active implants, consult the manufacturer of the implant or the relevant specialist department of your hospital prior to surgery. OBJ_DOKU-184381-013.fm Seite 31 Dienstag, 13. Dezember 2022 2:13 14
32 4.3 Risk of fire in the gastrointestinal tract Before using APC, always ensure that no endogenous gases are present in the lumen of the relevant organ. 4.4 Danger of fire in the tracheobronchial system Use of the instrument under too high oxygen concentration in the tracheobronchial system. Danger of fire in the respiratory tract for the patient! Reduce the oxygen supply below a critical threshold in accordance with therapeutic guidelines before activating the instrument in the tracheobronchial system. 4.5 Gas embolisms, gas emphysema In order to prevent gas embolisms, the argon flow rate must not be set so high that argon is injected into open vessels. To prevent gas embolisms or emphysemas, never point the distal end of APC probes directly at open vessels or press it against tissue. 4.6 Risk of capacitive coupling Risk of capacitive coupling: HF current can be transferred from the activated instrument to other instruments, even if the two are not touching (known as "capacitive coupling"). Risk of burns to the patient and/or operating theater staff: • Position the connecting cables of the instruments so that they are as far apart as possible. • Place the instrument at the usual working distance from the tissue before activating the instrument. • Do not use hybrid trocars (e.g. a combination of metal and plastic). Only use trocars designed for use with electrosurgical devices. • Only use approved endoscopes for electrosurgery. OBJ_DOKU-184381-013.fm Seite 32 Dienstag, 13. Dezember 2022 2:13 14
33 4.7 Danger of unintentional damage to nerve structures Bear in mind that during an APC application in the direct vicinity of nerve structures stimulation may be induced by electric currents. In the case of nerves which require protection it is advisable to keep the APC activation time short and adapt maximum power output to the required indication. 4.8 Risks in the case of endoscopic application The HF leakage current at the ocular of the endoscope may cause thermal injury to the user. In order to prevent this, please use only endoscopes designed for use with electrosurgical devices. Unwanted stimulation of nerves and muscles due to low-frequency currents. Dangerous summation of patient leakage currents from several power sources: It is not possible to entirely avoid low-frequency currents in electrosurgery, but they can be limited by applying technical measures to equipment and accessories. Limit types show how wide-ranging these measures are, e.g., type B, BF or CF as per EN 60601. Type CF offers the highest level of protection against low-frequency currents. However, please note the following: If you use an electrosurgical unit and an endoscope that is supplied with energy at the same time, the low-frequency currents from both power sources accumulate to form one single patient leakage current. If the electrosurgical unit belongs to type CF and the endoscope to type BF, the less favorable limit values for type BF apply to the overall patient leakage current. You should therefore only use power sources with the same type classification, ideally those of type CF. OBJ_DOKU-184381-013.fm Seite 33 Dienstag, 13. Dezember 2022 2:13 14
34 4.9 Risk of burns to the patient The distal end (1) of the APC probe should protrude at least 10 mm out of the distal end of the endoscope. This is ensured when the first black ring (2) on the distal end of the probe is visible through the endoscope. Fig. 1: View of the markings through the endoscope. 4.10 Danger of burns Argon plasma can strongly heat electrically conductive materials, e.g. metal. To avoid burns, never direct argon plasma towards electrically conductive materials. Inadvertently activated instruments and instruments that are still hot after use can cause burns or fires: • Store instrument away from the patient, never on the patient. • Do not touch the distal end of the instrument. • Never set the instrument down on flammable materials. Risk of burns as a result of leakage current. Position the connecting cable so that it does not touch the patient. 1 2 OBJ_DOKU-184381-013.fm Seite 34 Dienstag, 13. Dezember 2022 2:13 14
35 4.11 Risk of mechanical tissue perforation Probe tips that are pressed against tissue can unintentionally perforate it. The thinner the probe tip, the greater the risk. Avoid all contact between the probe tip and tissue. 4.12 Risk of accidental tissue damage with the APC 300 If the gas bottles of the APC 300 are not opened or are completely empty, a spray coagulation is performed with the instrument after each activation. There is an audible warning signal; the bottles on the display of the APC 300 blink and an error message appears. In the spray coagulation mode there is a danger of unintentional tissue damage; the instrument can also be damaged! Before using the APC 300 always open the gas bottles. Observe the self-check performed by the unit. How much gas is there left in the bottles? The bottle symbols on the display of the APC 300 give an approximate indication of the quantity of gas remaining. Never work with two gas bottles which are almost completely empty. When one gas bottle is empty, the APC 300 switches over to the second gas bottle automatically. Always observe the warning signals and error messages. 4.13 Modification of the product by the user Erbe Elektromedizin expressly warns against modifying the product. Any modification exempts Erbe Elektromedizin from any and all liability. OBJ_DOKU-184381-013.fm Seite 35 Dienstag, 13. Dezember 2022 2:13 14
36 5 How to use 5.1 Checking the expiration date The expiration date is indicated on the packaging. Do not use this product if the expiration date has been exceeded! 5.2 Checking and opening the packaging WARNING! Only use the product with intact, unopened sterile packaging. You can identify packaging that is damaged, and therefore no longer sterile from damaged seal seams, illegible labeling, damp or even wet areas, for example. Use aseptic techniques when removing the product from the packaging! 5.3 Checking the product CAUTION! Before use, check the insulation for damage, paying particular attention to the ceramic insulation at the distal end of the APC probe. Do not use this product if it is damaged. 5.4 Connecting the product and selecting unit settings WARNING! Risk of injury! Do not activate the electrosurgical unit while you are connecting the instrument. CAUTION! Select the device settings as low as possible to achieve the desired effect. IMPORTANT! The APC units are equipped with different APC sockets. Depending on the type of socket, you may or may not need an adapter to connect the probe. To determine your type of socket please read the chapter "Required accessories". OBJ_DOKU-184381-013.fm Seite 36 Dienstag, 13. Dezember 2022 2:13 14
37 Connection to an APC 300: IMPORTANT! The adapter, Art. No. 20132-227, must be plugged into the APC socket! 1. Switch the APC 300 and the electrosurgical unit on. 2. Insert the APC connector (1) into the adapter (2). 3. On the APC 300, a standard value for gas flow is set automatically. If required, this value can be changed within a certain range. You have to manually set mode and power on the electrosurgical unit. In doing so, it is essential that the settings recommended in the chapter "Maximum electrical capacity and unit setting" are observed. Connection to an APC 2 with APC socket : IMPORTANT! The adapter, Art. No. 20132-227, must be plugged into the APC socket! 1. Switch on the VIO electrosurgical unit and select the basic program. 1 2 OBJ_DOKU-184381-013.fm Seite 37 Dienstag, 13. Dezember 2022 2:13 14
38 2. Insert the APC connector (1) into the adapter (2). 3. On the VIO electrosurgical unit, a standard setting is configured for mode, power, effect, and gas flow. This standard setting is the same for all APC probes. In order to achieve the desired tissue effect, you may therefore have to adjust the mode, power, effect, and/or gas flow to the APC probe being used. The gas flow can only be changed within a certain range. Mode, power, and effect can be changed as required. Connection to an APC 2 with APC socket : 1. Switch on the VIO electrosurgical unit and select the basic program. 2. Insert the APC connector (1) into the APC socket (2). 1 2 1 2 OBJ_DOKU-184381-013.fm Seite 38 Dienstag, 13. Dezember 2022 2:13 14
39 3. For the connected APC probe, a standard setting is configured automatically on the VIO electrosurgical unit for mode, power, effect, and gas flow. You can change this standard setting within a certain range as required. Connection to an APC 3: 1. Switch on the VIO electrosurgical unit and pull up the main menu. 2. Insert the APC connector into the APC socket on the APC 3. 3. For the connected probe, a standard setting is configured automatically on the VIO electrosurgical unit for mode, effect level and gas flow. You can change this standard setting within a certain range as required. 5.5 Selecting the endoscope Select an endoscope with a working channel that has the matching diameter. To find the working channel diameter necessary for your APC probe please refer to the chapter "Maximum electrical capacity and unit setting". 5.6 Using the product IMPORTANT! It is essential that you read the chapter "Safety instructions". You will find valuable information about safe handling of the probes there. Safe application of the argon plasma: The argon plasma is applied axially, laterally, or radially, depending on the type of beam. You can find out the type of beam of your probe by referring to the chapter "Maximum electrical capacity and unit setting". In order to reliably locate the tissue you want to work on, please establish the type of beam before using the probe. OBJ_DOKU-184381-013.fm Seite 39 Dienstag, 13. Dezember 2022 2:13 14
40 Positioning probes with lateral beam (so-called Side-Fire Probes): On the side opposite the aperture of the probe (2) there is a longitudinal mark (1). Use this mark as a positioning aid when applying th argon plasma (3). Fig. 2: Lateral application of the argon beam with a Side-fire Probe. Protecting the head of the probe: If the head of the probe is pulled back and forth too forcefully in a longitudinal direction, it may be damaged or become entirely detached from the probe tube. This can occur above all during cleaning when using or removing the probe from the endoscope. Remove the probe from the endoscope with care. Never pull at the head of the probe while cleaning but wipe across it gently with a light rotary movement. 6 Disposal Dispose of the product, packaging material and accessories (if available) in accordance with the national guidelines and legislation applicable in each case. 1 3 2 OBJ_DOKU-184381-013.fm Seite 40 Dienstag, 13. Dezember 2022 2:13 14
41 7 Symbols Symbol Explanation Symbol Explanation Consult instructions for use Caution, read safety instructions before use. Follow instructions for use Catalogue number Medical device Batch code Manufacturer Use-by date1) 1.) The date next to the symbol is in the format Year-Month-Day. Keep away from sunlight Keep dry Quantity (x) Sterilized using ethylene oxide Do not use if package is damaged and consult instructions for use Do not re-use Do not resterilize Single sterile barrier system2) 2.) The date next to the symbol states the Year-Month-Day on which the sterile barrier system was sealed. Argon-Beam, axial (A) Argon-Beam, Side Fire Conical (SC) Argon-Beam, circumferential (C) European conformity marking X CE OBJ_DOKU-184381-013.fm Seite 41 Dienstag, 13. Dezember 2022 2:13 14