APC 2 User Manual V1.4x June 2013

User Manual

APC® 2

Registered trademarks of ERBE Elektromedizin GmbH: APC®, APC 300®, AUTO CUT®, AUTOCUT®, BICISION®, BiClamp®, CLASSIC COAG®, CLASSIC CUT®, CLEVERCAP®, DeCo®, DRYCUT®, ENDO CUT®, ENDOCOAG®, ENDOCUT®, ERBE®, ERBE logo (design mark), ERBECRYO®, ERBEFLO®, ERBEJET®, ERBELift®, ERBOKRYO®, FIAPC®, FORCEDAPC®, Hybrid knife®, HybridKnife®, Hydro-Jet®, ICC 200®, ICC 80®, NESSY®, NESSY Ω®, PRECISE APC®, PRECISEAPC®, Preflow®, PULSEDAPC®, ReMode®, REMODE®, SWIFT COAG®, SWIFTCOAG®, The Color Blue®, TWIN COAG®, VIO®.

EN ISO 9001 EN ISO 13485 User Manual Art. No. 80110-201 All rights reserved for this user manual in particular the right to reproduction and distribution, as well as translation. No part of this user manual may be reproduced in any form (e.g. photocopy, microfilm or other procedure) or processed, copied or distributed using electronic systems without the prior written consent of ERBE Elektromedizin GmbH. The information contained in this user manual may not be modified or expanded without prior notice and does not represent any obligation on the part of ERBE Elektromedizin GmbH. Printed by ERBE Elektromedizin Printed in Germany Copyright © ERBE Elektromedizin GmbH, Tübingen 2013

Table of Contents

Table of Contents

1

Safety Instructions... 7 Intended use... 7 Combination with other equipment... 7 Safety notations... 7 Meaning of the note... 7 Who must read this User Manual?... 7 Compliance with safety information... 8 Structure of safety instructions... 8 Operating errors and incorrect installation by persons without training... 8 Risks due to the environment... 9 Electric shock... 10 Fire / explosion... 11 Burns... 12 Risks due to incorrect use of the return electrode... 16 Defective unit... 16 Interference caused by the unit... 17 Damage to the unit and accessories... 18 Notes... 19

2

Additional safety instructions for APC... 21

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Fire / explosion... 21 Burns... 22 Risks due to gas embolisms or excessive intraluminal gas pressure... 22 Risk of infection... 23 Risks due to the pressure gas bottle... 23

3

Description of the Controls... 25 Controls... 25 Controls on the front panel... 25 Controls on the back... 26

4

Working with the APC 2 (in combination with a VIO from the D series)... 27 Preparations for start-up... 27 Setup parameters on the APC 2... 27

5

Working with the APC 2 (in combination with a VIO from the S series)... 29 Preparations for start-up... 29 Setup parameters on the APC 2... 29

6

Description of receptacle hardware... 31 Socket combinations on the APC module... 31 Purchasing further receptacles... 31 APC socket module... 32

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Table of Contents

FiAPC receptacle module... 32 Monopolar socket, bipolar socket, multifunctional socket... 32

7

Installation of the APC 2 and the Argon Pressure Cylinders... 33 Ambient conditions... 33 Electrical installation... 34 Installing the unit on an ERBE equipment cart... 34 Fixing argon pressure cylinders, connection of the working cylinder, detachment of the working cylinder on the VIO CART... 35 Fixing argon pressure cylinders, connection of the working cylinder, detachment of the working cylinder on the Universal Cart... 38 Risks due to the pressure gas bottle... 40 Refilling the working cylinder... 41

8

Cleaning and Disinfection... 43 Wipe disinfection... 43 Instructions for cleaning and disinfection... 43 Safety Instructions... 43

9

Status Messages, Error Messages... 45

10 General Technical Data... 47 11 Information on electromagnetic compatibility (EMC)... 49

12 Maintenance, Customer Service, Warranty, Disposal... 55 Maintenance... 55 Customer service... 55 Warranty... 55 Disposal... 56

13 Accessories... 57 Introduction... 57 APC 2 example accessories... 58

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Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic effects on other equipment or systems, which are the result of operating the VIO system... 49

1 • Safety Instructions

CHAPTER 1

Safety Instructions

Intended use APC 2 is an argon plasma coagulator for argon plasma coagulation (APC) withVIO electrosurgical units.

Combination with other equipment You can combine this unit with matching ERBE equipment: e.g. VIO electrosurgical units, IES 2, EIP 2. You will then have a well-conceived, coordinated system.

Safety notations

DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

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WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE indicates a potentially hazardous situation which, if not avoided, may result in property damage.

Meaning of the note "Note:" Refers a) to manufacturer's information that relates directly or indirectly to the safety of people or protection of property. The information does not relate directly to a risk or dangerous situation. Refers b) to manufacturer's information that is important or useful for operating or servicing the unit.

Who must read this User Manual? Knowledge of the User Manual is absolutely essential for correct operation of the unit.

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1 • Safety Instructions

The User Manual must therefore be read by everyone who works with the equipment. Anyone who prepares, sets, disassembles, cleans and disinfects the unit must also read the User Manual. Please pay particular attention to the safety instructions in each chapter.

Compliance with safety information Working with medical equipment is associated with certain risks to patients, medical personnel and the environment. Risks cannot be entirely eliminated by design measures alone. Safety does not depend solely on the equipment. Safety depends to a large extent on the training of medical personnel and correct operation of the equipment. The safety instructions in this chapter must be read, understood and applied by everyone who is working with the equipment.

Structure of safety instructions APC can only be performed with an APC 2 and a VIO electrosurgical unit. All the safety instructions for monopolar electrosurgery and additional safety instructions for APC apply. You will find the additional safety instructions for APC in Chapter 2. The safety instructions are structured according to the following risks:

• Risks due to the environment • Electric shock • Fire / explosion • Burns • Risks due to incorrect use of the return electrode • Defective unit • Interference caused by the unit • Damage to the unit and accessories • Notes

Operating errors and incorrect installation by persons without training

WARNING Operating errors and incorrect installation by persons without training Persons without training can operate or install the unit incorrectly. Risk of injury or death for patients and medical staff! Risk of damage to property.

 The equipment may only be used and installed by persons who have been trained on how to use and install it properly according to this User Manual.

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• Operating errors and incorrect installation by persons without training

1 • Safety Instructions

 Training may only be carried out by persons who are suitable on the basis of their knowledge and practical experience.  In the event of uncertainties or if you have any questions, please contact ERBE Elektromedizin. You will find the addresses in the address list at the end of this User Manual.

Risks due to the environment

NOTICE Interference with the unit by portable and mobile HF communication devices (e.g. mobile phones, WLAN equipment) Electromagnetic waves emitted by portable and mobile HF communication devices can effect the unit. The unit may fail or not perform properly.

 Please see the table "Recommended separation distances between portable and mobile HF communications equipment and the equipment" at the end of this User Manual.

NOTICE Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity, it may sustain damage, fail, or not perform properly.

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 Operate the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.  If other ambient conditions must be observed for operation of the equipment, you will also find them in the Technical Data.

NOTICE Unsuitable temperature or humidity in transit or storage If you transport or store the equipment at an unsuitable temperature or level of humidity, it may sustain damage and fail.

 Transport and store the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.  If other ambient conditions must be observed for transport and storage of the equipment, you will also find them in the Technical Data.

NOTICE Insufficient acclimatization time, unsuitable temperature during acclimatization If the device was stored or transported below or above a certain temperature, it will take a certain time and temperature to acclimatize. If you do not observe the rules, the device can sustain damage and fail.

 Acclimatize the device according to the rules in the Technical Data.

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1 • Safety Instructions

NOTICE Overheating of the device due to poor ventilation If ventilation is poor, the device can overheat, sustain damage, and fail.

 Install the device in such a way that there is an unobstructed circulation of air around the housing. Installation in confined wall recesses is prohibited.

NOTICE Penetration of liquid into the device The housing is not absolutely watertight. If liquid penetrates, the device can sustain damage and fail.

 Make sure no liquid can penetrate the device.  Do not place vessels containing liquids on top of the device.

Electric shock

WARNING

 Connect the unit / the equipment cart to a properly installed grounded power outlet.  Only connect the unit to a power supply network with proper grounding.  Only use the ERBE power cord or an equivalent power cord for this purpose. The power cord must bear the applicable national test symbol.  Check the power cord for damage. You must not use a damaged power cord.  The supply voltage must match the voltage specified on the unit's rating plate.  Do not use multiple power outlets.  Do not use extension cords.

WARNING Incorrect line fuse, defective device Risk of electric shock to the patient and medical personnel! Risk of damage to property.

 Blown line fuses may only be replaced by a competent technician. Only replacement fuses that have the same rating as the one specified on the unit’s rating plate may be used.  When a fuse has been changed, the function of the unit must be verified. If the unit does not function properly or if there are any concerns, please contact ERBE.

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Defective grounded power outlet, power supply network without proper grounding, inferior-quality power cord, incorrect line voltage, multiple power outlets, extension cords Risk of electric shock and other injuries to the patient and medical personnel! Risk of damage to property.

1 • Safety Instructions

WARNING Connection of unit / equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel!

 Switch off the device. Unplug the power cord of the device/ equipment cart.

Fire / explosion In electrosurgery electric sparks and arcs occur at the instrument. Flammable gases, vapors, and liquids can be set alight or caused to explode.

DANGER Flammable anesthetics Risk of explosion to the patient and medical personnel! Risk of damage to property.

 Do not use flammable anesthetics when an operation is being performed on the head or thorax.  If use is unavoidable, you must extract the anesthetics before performing electrosurgery.

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WARNING Flammable gas mixture in TUR (Transurethral Resection) and TCR (Transcervical Endometrial Resection) Hydrogen and oxygen can ascend into the roof of the bladder, the upper part of the prostate, and the upper part of the uterus. If you resect into this gas mixture, it could combust. Risk of combustion to the patient!

 Allow the gas mixture to escape through the resectoscope sheath.  Do not resect into the gas mixture.

DANGER Flammable endogenous gases in the gastrointestinal tract Risk of explosion to the patient!

 Extract the gases before performing electrosurgery or irrigate with CO2.  Or scavenge with argon.

DANGER Combustion-supporting gases, e.g. oxygen, nitrous oxide The gases can accumulate in materials like cotton wool or gauze. The materials become highly flammable. Risk of fire to the patient and medical personnel! Risk of damage to property.

 Do not use combustion-supporting gases when an operation is being performed on the head or thorax.  If use is unavoidable, you must extract the combustion-supporting gases before performing electrosurgery.

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1 • Safety Instructions

 Remove any jeopardized (e.g. cotton wool or gauze) materials before performing electrosurgery.  Check the oxygen-carrying tubes and connections for leaks.  Check the endotracheal tubes and their cuffs for leaks.

WARNING Active or hot instruments in contact with combustible materials Materials like gauze, swabs, and cloths can catch fire. Risk of fire to the patient and medical personnel! Risk of damage to property.

 Do not bring active or hot instruments into contact with combustible materials.  Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials.

WARNING Flammable detergents and disinfectants, flammable solvents in adhesives used on the patient and on the device / equipment cart Risk of fire and explosion to the patient and medical personnel! Risk of damage to property. If the use of flammable products is unavoidable, proceed as follows:

 Allow the products to evaporate completely before switching on the device.  Check whether flammable liquids have accumulated under the patient, in body recesses such as the navel, or in body cavities such as the vagina. Remove any liquids before performing electrosurgery.

WARNING Ignition of anesthetics, skin cleansers, and disinfectants in potentially explosive atmospheres If you place the device in a potentially explosive atmosphere, anesthetics, skin cleansers, and disinfectants can ignite. Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.

 Do not place the device in potentially explosive atmospheres.

Burns

WARNING Damaged device, damaged accessories, modified device, and modified accessories Risk of burns and injury to the patient and medical personnel! Risk of damage to property.

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 Use products that are not flammable.

1 • Safety Instructions

 Check the device and accessories for damage every time before using them (e.g. footswitch, cords of instruments and the return electrode, equipment cart).  You must not use damaged equipment or damaged accessories. Replace defective accessories.  If the equipment or equipment cart is damaged, please contact our customer service.  For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will invalidate liability on the part of ERBE Elektromedizin GmbH.

WARNING HF leakage current flows through metal parts The patient must not have contact with electrically conductive objects. That includes metal parts of the operating table, for example. HF current can be discharged through points of contact accidentally (HF leakage current). Risk of burns to the patient!

 Position the patient on dry, antistatic drapes.  If the drapes can become wet during the operation due to sweat, blood, irrigation liquid, urine, etc., lay a waterproof sheet over the drapes.

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WARNING HF leakage current flows through monitoring electrodes HF current can be discharged through points of contact between the skin and monitoring electrodes accidentally (HF leakage current). Risk of burns to the patient!

 Position monitoring electrodes as far away as possible from the surgical field (area where electrosurgical instruments are used).  Do not use needle electrodes for monitoring during electrosurgery.  Where possible, use monitoring electrodes that contain devices to limit high-frequency current.

WARNING HF leakage current flows through skin-to-skin points of contact HF current can be discharged through skin-to-skin points of contact accidentally (HF leakage current). Risk of burns to the patient!

 Prevent skin-to-skin points of contact. For example, lay dry gauze between the patient's arms and body.

WARNING Unintentional activation of the instrument Risk of burns to the patient and medical personnel!

 Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Instruments that have been put down must

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1 • Safety Instructions

not come into contact with the patient, medical personnel, or combustible materials.

 Instruments that have been put down must not come into contact with the patient, not even indirectly. An instrument can come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example.

CAUTION Hot instruments Even non-active instruments that are still hot can burn the patient or medical personnel.

 Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials.  Instruments that have been put down must not come into contact with the patient, not even indirectly. An instrument can come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example.

WARNING

All points that come into contact with the active part of the instrument are at risk. The cause of unintentional activation can be a fault in the footswitch or device or operator error, for example. You will recognize unintentional activation from the continuous activation signal. Risk of burns to the patient!

 Turn off the power switch on the electrosurgical unit immediately. Only then should the instrument be removed from the patient’s body.

WARNING Capacitive coupling between the cords of two instruments When one instrument is activated, current can be transferred to the cord of another instrument (capacitive coupling). The patient can suffer burns if the non-active but still live instrument has direct or indirect contact with the patient. Risk of burns to the patient!

 Lay the cords of instruments in such a way that they are as far apart as possible.  Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see.  Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials.  Instruments that have been put down must not come into contact with the patient, not even indirectly. An instrument can

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Unintentional activation of the instrument during an endoscopic application If the instrument is activated and remains activated during an endoscopic application, the patient can suffer burns when the instrument is removed.

1 • Safety Instructions

come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example.

WARNING Power setting too high, ON time too long, effects too high The higher the power setting the longer the ON time of the unit and the higher the effect the higher the risk of accidental tissue damage. Risk of accidental tissue damage to the patient!

 Set power as low as possible relative to the required surgical effect. However, power settings that are too low can be dangerous, e.g. gas embolisms with the APC (Argon Plasma Coagulation).  Activate the unit for as short a time as possible relative to the required surgical effect.  The temperature at the return electrode site increases during long and continuous activations; therefore, ensure that the cooling phases between activations are sufficient.  Set effect as low as possible relative to the required surgical effect.  If you are unable to achieve a surgical effect with a power setting / ON time / effect level that is sufficient judging from experience, this can be due to a problem with the electrosurgical unit or accessories:  Check the instrument for soiling with insulating tissue remnants.  Check the return electrode to make sure it is secure.

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 Check the connectors on all cords to make sure they are secure.

WARNING Activation of the unit with no knowledge of active settings If the user does not understand the active settings of the unit, he can cause the patient accidental tissue damage.

 Check the active settings on the display of the unit, after: switching on the unit, connecting up an instrument, and changing the program.

WARNING The user was not informed of a change in maximum ON time Risk of accidental tissue damage to the patient!

 All users must be informed of any change in maximum ON time at an early stage. That is, before the user works with the modified maximum ON time for the first time.  The temperature at the return electrode site increases during long and continuous activations; therefore, ensure that the cooling phases between activations are sufficient.

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1 • Safety Instructions

WARNING Tissue structures / vessels with a cross-section that is small or becoming smaller If monopolar HF current flows through parts of the body with a relatively small cross-section, there is a risk of unintentional coagulation for the patient!

 If possible, use the bipolar coagulation technique.

WARNING Activation signal not audible You do not hear the signal when the electrosurgical unit is activated. Risk of burns to the patient and medical personnel!

 Adjust the activation signal so that it is clearly audible.

WARNING Undesirable contact between the active instrument and metal objects in the patient's body Contact with metal hemostats, etc. Risk of burns to the patient!

 Do not touch metal objects (e.g. implants) in the patient's body with the active instrument.

A hand-held metal instrument is touched with the active instrument (electrode) Risk of hand burns!

 Such practice is not recommended. The risk of burns cannot be ruled out.

Risks due to incorrect use of the return electrode Please read the safety instructions in the User Manual for the VIO electrosurgical unit.

Defective unit

WARNING Undesirable rise in output level due to failure of electrosurgical unit Risk of accidental tissue damage to the patient!

 The device shuts off independently.  To guard against a possible failure of the electrosurgical unit, have the device checked for safety at least once a year.

WARNING Technical safety checks not being done Risk of injury or death for patients and medical staff! Risk of damage to property.

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CAUTION

1 • Safety Instructions

 Have the device checked for safety at least once a year.  You must not use a device that is not safe.

WARNING Failure of display elements If display elements fail, you can no longer operate the device safely. Risk of injury or death for patients and medical staff!

 You must not use the unit.

Interference caused by the unit

WARNING Interference with cardiac pacemakers, internal defibrillators, or other active implants Activation of the electrosurgical unit may affect the performance of active implants or damage them. Risk of injury or death for patients and medical staff!

 In the case of patients having active implants, consult the manufacturer of the implant or the competent department of your hospital prior to performing surgery.  Do not position the return electrode near cardiac pacemakers, internal defibrillators, or other active implants.

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NOTICE Interference with electronic equipment due to the electrosurgical unit The activated electrosurgical unit can affect the performance of electronic equipment by causing interference. The equipment may fail or not perform properly.

 Position the electrosurgical unit, the cords of the instruments, and the cord of the return electrode as far away as possible from electronic equipment.  Position the cords as far away as possible from the cords of electronic equipment.

WARNING Low-frequency currents stimulate nerves and muscles (Neuromuscular Stimulation) Low-frequency currents arise either due to low-frequency power sources or partial rectification of the HF current. During cutting procedures, forced coagulation and spray coagulation, the unavoidable electric arcs between an active electrode and the tissue have the effect that a portion of the high-frequency alternating current is rectified. Spasms or muscle contractions can occur. Risk of injury to the patient.

 Set effect as low as possible relative to the required surgical effect.

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1 • Safety Instructions

NOTICE Use of non-approved internal cables by Technical Service This can result in the increased emission of electromagnetic waves or reduce the immunity of the device. The unit may fail or not perform properly.

 Technical Service may only use the internal cables that are listed in the service manual for the device.

NOTICE Stacked devices If you stack the device next to other equipment or with other equipment, the devices can affect each other. The unit may fail or not perform properly.

 The device may only be stacked next to or with VIO series units.  If it is necessary to operate the device near other equipment or stacked together with other equipment, check whether the devices are affecting each other: Are the devices behaving unusually? Do errors occur?

Damage to the unit and accessories

Alcohol-based spray disinfectant for fast disinfection With membrane keyboards and paint surfaces there is the risk of cracks. Propanol and ethanol will erode surfaces.

 Do not use these substances.

NOTICE Alternate use of disinfectant solutions based on different active ingredients A color reaction may occur with plastics.

 Do not use these substances alternately.

NOTICE Mix-up of receptacles on monopolar receptacle modules 20140-622, 20140-623 If the receptacles are mixed up, the unit will be damaged.

 If you use a connecting cord with a monopolar 4 mm dia. connector, you may only plug the connector into the receptacle with the blue ring. The correct receptacle is marked with an arrow on the illustration.

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NOTICE

1 • Safety Instructions

Fig. 1-1

NOTICE Electric load on instrument too high The instrument can be damaged. If the damaged area comes into contact with tissue, it can lead to unintentional coagulation.

 Determine the electrical capacity of the instrument. It is either printed on the instrument or can be found in the user manual. Compare the electrical capacity of the instrument with the maximum HF peak voltage of the required mode.

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 Instructions are available in the "Accessories" chapter of the VIO user manuals.

Notes Grounding

Note: If necessary, the equipment can be connected to the external grounding system of the room with the grounding pin on the back of the unit and/or Cart using a connecting cable designed for this purpose. Affects of low frequency leakage currents due to a defective grounding system within the room may be eliminated through external grounding.

Use of a defibrillator

Note: The equipment conforms to the requirements of Type CF and is protected against the effects of a defibrillator discharge.

Membrane keyboards

Note: If alcohol-based disinfectants are used on units with membrane keyboards, this remove the anti-glare finish. However, the user surfaces remain fully functional. This does not present a hazard.

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1 • Safety Instructions

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2 • Additional safety instructions for APC

CHAPTER 2

Additional safety instructions for APC

The safety instructions are structured according to the following risks: • Fire / explosion • Burns • Risks due to gas embolisms or excessive intraluminal gas pressure • Risk of infection • Risks due to the environment

Fire / explosion

DANGER

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Hot tissue, combustible materials, and oxygen in the tracheobronchial system Due to APC the tissue can become so hot that it can ignite combustible materials in the vicinity, e.g. due to hot particles flying around. Combustible materials are, for example, plastic insulation at the distal end of the bronchoscope or a tracheal tube. However, ignition is only possible if a fire-supporting gas, e.g. oxygen, is present at the same time. This particularly applies to highly concentrated oxygen or pure oxygen. Risk of burns to the patient!

 Do not admit any oxygen to the tracheobronchial system directly before, and particularly during, APC. Do not admit any other combustible or fire-supporting gases (e.g. nitrous oxide) or combustible liquids either.  If APC is used for a lengthy period of time: Administer the oxygen required for patient ventilation and APC alternately.  The distal end of the APC applicator must always be in the field of view of the endoscope before and during activation of the argon plasma. Never activate the argon plasma without visual control.  Keep the argon plasma as far as possible away from combustible materials.

DANGER Combustible gas mixture in the tracheobronchial system Hemostasis and devitalization of tissue produce smoke. In conjunction with oxygen a highly combustible gas mixture develops. Risk of burns to the patient!

 Short activation pulses reduce development of the gas mixture.  Extract the gas mixture.

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