APU-300 ARGON PLASMA COAGULATION UNIT Instructions for Use July 2018

Content 1 General information...5 1.1 User instructions...5 1.2 Signal words...5 1.3 Conventions throughout this document...5 1.4 Manufacturer...6 2 Safety information...7 2.1 Intended use...7 2.2 Contraindications...7 2.3 User qualification...7 2.4 Environment of use...7 2.5 General warnings and cautions...8 2.5.1 Risks regarding the supply of argon gas...8 2.5.2 Risks regarding the handling of the gas cylinder and the pressure reducer...9 2.5.3 Risks regarding environmental conditions...10 3 Product description...11 3.1 Scope of delivery...11 3.2 Symbols...11 3.3 Nomenclature and functional principles...12 3.4 The communication cable MAJ-1871...14 3.5 Warranty...14 4 Installation...15 4.1 General inspection...15 4.2 Placement of the APU‑300 and the ESG‑300...15 4.3 Installation and connection to the ESG‑300...15 4.4 Connecting the argon gas supply...17 4.4.1 Connection to an argon gas cylinder...17 4.4.2 Connection to a central argon supply...18 4.5 Connecting the APU‑300 to the mains electricity...19 4.6 Purging...19 5 Operation...20 5.1 Starting and stopping argon plasma...20 6 Alarms and messages...21 6.1 Alarm system with electrosurgical generator ESG‑300...21 6.2 Error messages and message boxes...21 7 Disconnecting the cylinder gas supply...22 8 After use...23 8.1 Disconnecting the APU‑300 from the mains electricity...23 8.2 Reprocessing...23 8.2.1 General information for reprocessing...23 8.2.2 Cleaning...23 8.2.3 Disinfection...24 8.2.4 Other HF equipment...24

9 Annual safety check...25 10 Repair, shipment and disposal...26 10.1 Repair...26 10.2 Shipment...26 10.3 Disposal...26 11 Compatible equipment...27 11.1 System chart...27 12 Technical data...29 12.1 Specifications...29 12.2 Classification of ME equipment and ME systems...29 12.3 Ambient conditions...29 13 Electromagnetic compatibility...30

Figures Figure 3.1 Front panel of APU‑300...12 Figure 3.2 Rear panel of the APU‑300...13 Figure 3.3 Communication cable MAJ-1871...14 Figure 4.1 Installed mounting brackets...15 Figure 4.2 Fixed mounting brackets...16 Figure 4.3 Connected communication cable...16 Figure 4.4 Connecting the pressure sensor...17 Figure 4.5 Connecting the gas hose...18 Figure 11.1 System chart...27

General information

1 General information 1.1 User instructions •• Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. •• If the required instructions for use are missing, immediately contact an Olympus representative. •• Keep the instructions for use in a safe, accessible location.

1.2 Signal words The following signal words are used throughout this document. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury. NOTICE Indicates a property damage message.

1.3 Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information. 1. A numeration indicates a sequence of actions. 2. 3. • Bullet points indicate individual actions or different options for action. - Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. 2) 3) […] Bracketed terms refer to elements in the graphical user interface or keys. Elements in the graphical user interface can be: - buttons - menu items - dialog elements

5

General information

1.4 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

6

Safety information

2 Safety information 2.1 Intended use The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.

2.2 Contraindications There are no known contraindications.

2.3 User qualification Medical use This product is only intended to be used by a trained physician who is experienced in the use of argon plasma coagulation or by a trained physician under the supervision of an experienced user. These instructions for use do not explain or discuss clinical procedures. Argon gas supply The installation, connection and handling of the argon gas supply must only be performed by a technician who is familiar with gas supplies. Annual safety check The annual safety check must only be performed by a qualified electrician with sufficient experience in maintaining medical electrical devices. Furthermore, the user must have received authorized training by Olympus for the calibration of the gas flow. Repair Repair of the product must only be performed by qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product.

2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. Reprocessing Reusable products must be reprocessed according to the applicable national and local standards and regulations. Annual safety check The annual safety check must only be carried out in a technical laboratory with appropriate equipment.

7

Safety information

2.5 General warnings and cautions The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the dangers, warnings and cautions given in each chapter in this document or in the instructions for use of any product being used with this product. WARNING Fire and explosion due to flammable and combustion supporting gases The combination of endogenous gases, air and/or oxygen and the spark from the argon plasma coagulation system can cause fire and explosion. This can result in death of or severe injury to the patient. To minimize the risk observe the following: •• The use of flammable anesthetics and combustion supporting gases (oxidants) such as nitrous oxide (N20) and oxygen should be avoided when an operation is being performed, unless these substances are removed by extractors. •• With the argon probe outside of the patient, press the PURGE button on the APU‑300 every time an argon probe is connected to displace air from the system. •• Press the PURGE button twice after the argon gas supply has been set up. This ensures that air is completely displaced from the whole system. •• Refer to the section “Purging” on page 19. •• Do not perform electrosurgery within an explosive atmosphere. Keep flammable gases away from the treatment site. For the gastrointestinal tract •• Only use CO2 for insufflating the treatment site. Do not use air or oxygen for insufflation. •• Ensure that adequate gastrointestinal patient preparation is carried out to remove endogenous gases. •• Consider that flammable gas can be present beyond any constriction in the colon when treating a tumor causing colon occlusion. WARNING Cardiac arrest Using HF (high frequency) equipment on patients with implanted electronic devices, e.g. cardiac pacemakers, can cause failure of the implanted electronic device. Failure of the implanted electronic device will affect the heart and can result in cardiac arrest. •• Prior to the HF procedure, confirm its safety with a cardiologist or the manufacturer of the implanted electronic device. •• Position the neutral electrode in such a way that the current pathway does not pass through or near the implanted electronic device and its lead system. •• Do not apply the single use plasma coagulation probe in close proximity to the implanted electronic device. 2.5.1 Risks regarding the supply of argon gas WARNING Purity of argon gas Using argon gas with insufficient purity can result in inconsistent tissue effect. •• Only use argon gas. •• Only use argon gas with a purity of 4.8 (99.998%) or higher. •• Do not use the argon gas cylinder if the label is damaged or illegible.

8

Safety information

CAUTION Argon gas leakage A leakage in the argon gas connection unnoticeably enriches the respiratory air and can result in oxygen deficiency and asphyxiation. Symptoms for oxygen deficiency are drowsiness, increased blood pressure or difficulty in breathing. •• Make sure to have an gastight connection of the gas hose between the pressure reducer and the APU‑300. •• Make sure to have an gastight connection between the pressure reducer and the argon gas cylinder. NOTICE Supply pressure by a central argon gas supply If the supply pressure of a central argon gas supply exceeds 7 bar (100 psi) then this can cause a leak and the APU‑300 can be damaged. •• Make sure that the supply pressure of the central argon gas supply is between 3 bar (45 psi) and 7 bar (100 psi). NOTICE Supply pressure of an argon gas cylinder A supply pressure of the argon gas cylinder that exceeds 250 bar (3625 psi), as displayed on the pressure gauge of the pressure reducer, can damage the pressure reducer. •• Make sure that the supply pressure of the argon gas cylinder does not exceed 250 bar (3625 psi). 2.5.2 Risks regarding the handling of the gas cylinder and the pressure reducer WARNING Temperature of gas cylinder A surface temperature of the argon gas cylinder of more than 40 °C (104 °F) produces excessive pressure inside the gas cylinder. There is a risk of injury due to a bursting gas cylinder. •• Protect the gas cylinder from heating, e.g. by solar exposure, a radiator or open fire. •• Make sure that the surface temperature of the argon gas cylinder does not exceed 40 °C (104 °F). CAUTION Handling of argon gas cylinders Inappropriate handling of the argon gas cylinder can damage the equipment and can result in injury to the user. •• The argon gas cylinder must be handled by trained staff only. •• Refer to the safety instructions of the argon gas cylinder. •• Do not apply excessive force to any part of the argon gas cylinder •• Before use, inspect the argon gas cylinder for damage. •• Do not use a damaged argon gas cylinder. •• During transport, make sure that the valve protection (cap or collar) is used. •• Make sure that the argon gas cylinder complies with all applicable national and local laws and guidelines. •• Follow all applicable national and local laws and guidelines for transport, storage, handling, use and disposal of the argon gas cylinder. CAUTION Fastening the argon gas cylinder If the argon gas cylinder falls or topples then this can result in injury to the medical personnel.

9

Safety information

•• During operation as well as during transport and storage, fix the argon gas cylinder, e.g. with a belt. •• Make sure that the argon gas cylinder is securely clamped when installed on a compatible trolley. CAUTION Handling of the pressure reducer Inappropriate handling of the pressure reducer can damage the equipment and can result in injury to the user. •• Do not apply excessive force to any part of the pressure reducer. •• Before use, inspect the pressure reducer for damage. Especially inspect the following: -- The O-ring in the gas cylinder coupling screw (only for WA94041A, WA94042A, WA94045A). -- The gas hose. •• Do not use a damaged pressure reducer. CAUTION Compatible pressure reducer Using an incompatible pressure reducer can result in injury to the user and the medical personnel. •• Only use a compatible Olympus pressure reducer as mentioned in the chapter “Compatible equipment” on page 27. NOTICE No lubricants Using lubricants when connecting the pressure reducer to the argon gas cylinder and to the APU‑300 can result in equipment damage. •• Do not apply any lubricants. 2.5.3 Risks regarding environmental conditions CAUTION The argon plasma coagulation unit can disturb other equipment The argon plasma coagulation unit complies with the standards as described in the chapter “Electromagnetic compatibility” on page 30. However, during activation, high frequency signals or spark discharge noise generated by the argon plasma coagulation unit can disturb neighboring electrical equipment. Malfunction of the devices can occur, e.g. the monitor of endoscopic imaging equipment might freeze or black out, which can result in injury to the patient. •• Follow the instructions regarding electromagnetic ambient conditions given in the chapter “Electromagnetic compatibility” on page 30. •• Make sure that argon plasma coagulation unit is not used adjacent to or stacked with equipment that is not part of this argon plasma coagulation unit or system. •• Before use, thoroughly confirm the compatibility of all equipment. •• Do not use the argon plasma coagulation unit in conjunction with: -- Electrical equipment for which the safety against leakage current is not confirmed. -- Electrosurgical equipment for which the safety in combined use is not confirmed. •• Do not loop cables. •• Do not bundle cables together with cables belonging to other medical equipment.

10

Product description

3 Product description 3.1 Scope of delivery •• Before use, check that all items listed below are available. •• Contact an Olympus representative or an authorized service center if any items are missing or damaged. -- Argon plasma coagulation unit APU‑300 -- Communication cable MAJ-1871 -- Mounting brackets including screws (W7114351) -- Instructions for use

3.2 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product. Symbol

Explanation

Symbol

Explanation

Caution, consult accompanying documents

Warning, explosive material

Catalog number ​

Fragile, handle with care

Serial number

Keep away from rain. Keep dry

Quantity of content

This way up

Manufacturer

Stacking limit by number

Date of manufacture

CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/EEC

Follow instructions for use

Federal (USA) law restricts this device to sale by or on the order of a physician

Storage conditions

Defibrillation-proof type CF applied part

Transport conditions

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately.

Indicates the range of humidity to which the medical device can be safely exposed

Green Dot-symbol for dual recycling system

11

Product description Symbol

Explanation

Symbol

Indicates the temperature limits to which the medical device can be safely exposed Indicates the range of atmospheric pressure to which the medical device can be safely exposed

Explanation Indicates a recovery/recyclable package or package material

---

---

3.3 Nomenclature and functional principles Olympus Argon System The argon plasma coagulation unit APU‑300 is part of the Olympus Argon System for performing monopolar argon plasma coagulation procedures. The Olympus Argon System consists of: -- The electrosurgical generator ESG‑300, including foot switch -- The argon plasma coagulation unit APU‑300 -- An Olympus argon probe -- A compatible Olympus endoscope -- Optional: TC‑E300 Energy Cart The front panel of the APU‑300

Figure 3.1

Front panel of APU‑300

1) Docking connector To connect the APU‑300 to the compatible electrosurgical generator. 2) PURGE button To purge the system with argon gas. 3) ARGON socket To connect a compatible argon probe.

12

Product description

4) UDI (unique device identifier) 5) Power switch To switch the APU‑300 on and off. The rear panel of the APU‑300

Figure 3.2

Rear panel of the APU‑300

1) Name plate 2) Pressure sensor socket To connect the pressure sensor plug of the pressure reducer. 3) Drainage pin To relief the pressure in the gas hose of the pressure reducer when disconnecting the argon gas cylinder. 4) Argon connector To connect the gas hose’s quick release coupling of the pressure reducer or the tubing of the hospital’s central argon gas supply. 5) Equipotential bonding point To increase electrical safety by potential equalization. 6) Threaded holes for mounting brackets To secure the housing of the APU‑300 to the housing of the compatible electrosurgical generator ESG‑300. 7) Power socket with fuse holder To connect the APU‑300 to the mains electricity. 8) LINK OUT socket To connect the APU‑300 and the compatible electrosurgical generator ESG‑300 via the communication cable MAJ-1871. 9) LINK IN socket To connect peripheral equipment via a communication cable with a 14-pin plug.

13

Product description

3.4 The communication cable MAJ-1871

Figure 3.3

Communication cable MAJ-1871

1) Plug for APU‑300 side 2) Plug for ESG‑300 side

3.5 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

14

Installation

4 Installation 4.1 General inspection Before installing and connecting, inspect the APU‑300 and its equipment as follows. •• Check that the APU‑300, its equipment and all accessories do not have: -- any dents, cracks, kinks, or deformations -- any deep scratches -- any corrosion -- any missing or loose parts •• Check all markings on the APU‑300, its equipment and all accessories for clear visibility.

4.2 Placement of the APU‑300 and the ESG‑300 To prevent malfunction or damage of the APU‑300, the ESG‑300 and its accessories, take account of the following circumstances for placement: •• Place the devices on a stable, level surface. •• Put the devices upright onto their feet. Do not install the devices on its side or upside down. •• If the APU‑300 and the ESG‑300 are placed on a trolley, then the trolley must be of adequate strength and size to hold both devices securely. •• Make sure that there is sufficient space at the sides of the devices to allow air circulation at the ventilation slots. •• Only use the devices in compliance with the environmental conditions as specified. •• When lifting up, grip the devices at its sides with both hands. Do not hold the APU‑300 or the ESG‑300 at their fuse holders. •• If the APU‑300 and the ESG‑300 are placed on the compatible TC‑E300 Energy Cart, then refer to the instructions for use of the TC‑E300.

4.3 Installation and connection to the ESG‑300

Figure 4.1

Installed mounting brackets

15

Installation

1. Install the mounting brackets to the rear panel of the APU-300 with the supplied screws as show in the figure above. 2. Place the ESG-300 onto the top of the APU-300. Ensure that the docking connectors of both devices are correctly mated.

Figure 4.2

Fixed mounting brackets

3. Fix the mounting brackets to the rear panel of the ESG-300.

Figure 4.3

Connected communication cable

4. Connect the plug for APU-300 side of the communication cable to the LINK OUT socket of the APU-300. 5. Connect the plug for electrosurgical generator side to the LINK IN socket of the ESG-300.

16

Installation

4.4 Connecting the argon gas supply It is possible to connect the APU‑300 either to an argon gas cylinder or to the hospital’s central argon gas supply. •• Before connecting the argon gas supply ensure that the correspondent setting on the ESG‑300 is selected. When an argon mode is selected, then this is indicated by the argon supply indicator (gas cylinder supply or central supply) on the touchscreen of the ESG‑300. •• Refer to the instructions for use of the compatible electrosurgical generator ESG‑300 for the correct setting on the touchscreen for either of the supply possibilities. 4.4.1 Connection to an argon gas cylinder Preparing the argon gas cylinder and the pressure reducer •• For installing the pressure reducer on the argon gas cylinder refer to the instructions for use of the pressure reducer. •• If the argon gas cylinder is placed on the compatible TC‑E300 Energy Cart, then refer to the instructions for use of the TC‑E300. Connecting the pressure sensor cable

Figure 4.4

Connecting the pressure sensor

1. Align the triangle on the pressure sensor plug with the notch of the pressure sensor socket as shown in the figure above. 2. Insert the pressure senor plug into the socket. 3. Rotate the retaining ring of the pressure sensor plug until it is completely tight. Connecting the gas hose 1. Remove the protective cap from the quick release coupling.

17

Installation

Figure 4.5

Connecting the gas hose

2. Push the quick release coupling of the gas hose straight onto the argon connector. A click sound is audible when the connection is completely engaged. 3. Secure the quick release coupling by rotating the locking ring into the “LOCK” direction by approximately 90 °. The triangle on the orange band aligns with the triangle of the locking ring. 4. Slowly open the valve on the argon gas cylinder by turning the valve screw counterclockwise until the valve is completely open. As the argon flows through the gas hose a very sound hissing can be heard. For a full argon gas cylinder the reading on the pressure gauge should be approximately 200 bar (3000 psi). Leakage detection A hissing sound that lasts longer than 2 seconds or an unusual low reading on the pressure gauge indicates a leakage. In case of a leakage proceed as follows: 1. Close the valve screw of the argon gas cylinder. 2. Check the gastight connection of the gas cylinder coupling screw between the pressure reducer and the argon gas cylinder. 3. Check the gastight connection between the quick release coupling of the gas hose and the APU‑300. 4. If the reasons for the leakage cannot be identified, then stop using this argon gas cylinder and this pressure reducer. 4.4.2 Connection to a central argon supply Requirements for the gas hose connector The argon connector at the rear panel of the APU‑300 is suitable for KK couplers manufactured by SMC with a body size of 1/8, e.g. KK30S-02F Requirements for the supply pressure The central argon gas supply must deliver a supply pressure between 3 bar (45 psi) and 7 bar (100 psi).

18

Installation

4.5 Connecting the APU‑300 to the mains electricity WARNING Electric shock In case that a damaged argon plasma coagulation unit is connected inadequately to the mains electricity, there is the risk that internal electrical components conduct voltage to the housing. This can result in electric shock to the user. •• Connect the mains plug of the power cable directly to a grounded fixed socket-outlet. •• If a multiple socket-outlet is used take account of the following: •• The multiple socket-outlet must be equipped with an insulating transformer of protection class I, conforming to IEC 60601-1. •• Observe the maximum permitted current or power loading of the multiple socket-outlet and the insulating transformer. Power cable 1. Make sure that the APU‑300 is turned off, i.e. the power switch must not be depressed. 2. Connect one plug of the power cable to the power socket on the rear panel of the APU‑300. 3. Connect the other plug of the power cable to the socket-outlet of the mains electricity. Equipotential bonding point The purpose of additional equipotential bonding is to equalise potentials between different metal parts that can be touched simultaneously in the medical environment. Equipotential bonding increases electrical safety. •• Connect the pin at the rear panel of the electrosurgical generator to an equipotential bonding lead. Contact the hospital’s technical department. Connecting when placed on the compatible cart •• If the APU‑300 and the ESG‑300 are placed on the compatible TC‑E300 Energy Cart, then refer to the instructions for use of the TC‑E300.

4.6 Purging Purging is essential to ensure that argon gas is present at the tip of the argon probe and that gases like oxygen or air are displaced. The presence of oxygen or air in a flammable environment (e.g. methane, hydrogen) like the bowel can cause fire and explosion when activating argon plasma coagulation. •• Press the PURGE button twice directly after the setup of the argon gas supply. This ensures that the complete system is purged with argon gas. As soon as an argon probe is connected to the APU‑300 the electrosurgical generator displays a message box that prompts the user to perform purging again. This ensures that also the argon probe is purged with argon gas.

19

Operation

5 Operation During operation the APU‑300 is controlled via the electrosurgical generator ESG‑300. Despite of the power switch and the PURGE button on the front panel, there are no control elements on the APU‑300 itself. All settings are selected via the touchscreen of the ESG‑300. Message boxes and error messages regarding argon plasma coagulation are also displayed via the ESG‑300. •• For correct and safe operation of the APU‑300 also refer to the instructions for use of the electrosurgical generator ESG‑300 and of the compatible argon probes.

5.1 Starting and stopping argon plasma Argon plasma is activated as soon as the HF current of the ESG‑300 is activated, i.e. the blue coagulation pedal of the foot switch is depressed. When releasing the pedal, argon plasma and HF current are stopped, which stops the coagulation process.

20

Alarms and messages

6 Alarms and messages 6.1 Alarm system with electrosurgical generator ESG‑300 The alarm system of the APU‑300 constantly performs self-checking to ensure its correct operation. Error codes are reported to the user based on time and weighting of those self checks. If the alarm system of the APU‑300 detects an alarm condition, then the output of argon gas is stopped automatically. The alarm conditions is sent to the ESG‑300, which generates the appropriate alarm signal. The maximum delay between detecting the alarm condition (APU‑300) and generating the alarm signal (ESG‑300) is 150 ms. When the user confirms the alarm signal on the touchscreen of the ESG‑300, a response is sent to the APU‑300. As soon as the APU‑300 receives the response, or as soon as the alarm condition no longer exists, the alarm condition is no longer sent to the ESG‑300. •• Don’t rely upon the alarms signals of the APU‑300 if the communication between the ESG‑300 and the APU‑300 is lost. A correct communication between the two devices is indicated by the communication indicator on the top right of the home screen of the ESG‑300.

6.2 Error messages and message boxes Errors of the APU‑300 are generally detected and reported to the ESG‑300 within 1 second of occurrence. The exceptions are: -- Errors regarding gas flow, which are detected and reported within 2 seconds. -- Errors regarding a stuck PURGE button, which are detected and reported within 10 seconds. All errors are also checked when the devices are switched on. This means that also the errors regarding gas flow and regarding a stuck PURGE button are detected and reported immediately. All user relevant error messages that can arise are listed in the instructions for use of the electrosurgical generator ESG‑300, chapter “Troubleshooting”.

21