ESG-300 SYSTEM Test tools for ESU Maintenance Instructions for Use Nov 2017

Contents 1 General information...5 1.1 User instructions...5 1.2 Conventions throughout this document...5 1.3 Manufacturer...5 1.4 Name plates...6 2 Safety information...7 2.1 Intended use...7 2.2 User qualification...8 2.3 Environment of use...8 2.4 General safety messages...8 3 Product description...10 3.1 Scope of delivery...10 3.2 Simulator, for foot switch...11 3.3 Simulator, for sparks...11 3.4 Test cable, for ARGON socket...12 3.5 Pressure reducers, adjustable, 0-10 bar...12 3.6 Test hose, for argon connector...13 3.7 Test probe, Ø 2.3 mm, for ARGON socket...14 3.8 Test pressure sensor cable, for pressure sensor socket...14 3.9 Blockage tool, for test probe...15 3.10 Load resistors...15 3.11 Maintenance set, for ESG‑300 system...16 3.12 Symbols...16 3.13 Warranty...16 4 Use...17 5 Maintenance...18 5.1 Cleaning...18 5.2 Visual inspection...18 5.3 Functional test of the sparks simulator...18 6 Packaging, transport and storage...19 6.1 Packaging and transport...19 6.2 Storage...19 7 Repair, shipment and disposal...20 7.1 Repair...20 7.2 Shipment...20 7.3 Disposal...20 8 Ordering information...21 9 Technical data...22 9.1 Specifications...22 9.2 Ambient conditions...25

General information

1 General information 1.1 User instructions These instructions for use contain essential information on using these products safely and effectively. The complete set of instructions for use for these products consists of the following documents: -- Instructions for use for the electrosurgical generator ESG‑300 -- Instructions for use for the argon plasma coagulation unit APU‑300 -- Instructions for use for the ESG-300 system test tools (this document) -- Maintenance manual for the ESG‑300 system •• Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the safety check procedures. •• If the required instructions for use are missing, immediately contact an Olympus representative. •• Keep the instructions for use in a safe, accessible location. These instructions for use contain a description of the maintenance test tools for ESG‑300 and APU‑300 that are required for the annual safety check of the ESG‑300 system. These instructions for use do not contain information on performing the safety check. •• For the safety check procedures, refer to the maintenance manual for the ESG‑300 system.

1.2 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)

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

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General information

1.4 Name plates The products are provided with name plates for identification. When products are small, the name plates are attached to their packaging. The following figure illustrates the structure of the name plates.

Xxxxxxxxxxxxxxxxxxxx WAxxxxxx sxxxxx

(01)04042761073776(17)110601(10)030708

1) 2) 3) 4) 5) 6) 7)

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Quantity of content Date of manufacture Manufacturer Barcode Serial number Catalog number Product description

OLYMPUS WINTER & IBE GmbH Kuehnstr. 61 22045 Hamburg, Germany

1 YYYY-MM-DD

Safety information

2 Safety information 2.1 Intended use Simulator, for foot switch WA80003S The foot switch simulator is intended for simulating a foot switch when testing and calibrating the ESG‑300 system. Simulator, for sparks WA80004S The sparks simulator is intended for simulating sparking voltage. Test cable, for ARGON socket WA80005S The test cable for ARGON socket is intended to connect the APU‑300 to the sparks simulator for functional tests of the APU‑300. Pressure reducers, adjustable, 0-10 bar WA80006S, WA80007S, WA80008S, WA80009S, WA80010S The pressure reducers are intended to connect the APU‑300 or a flow meter to an argon gas cylinder and to adjust the outlet pressure for performing maintenance work. Test hose, for argon connector WA80011S The test hose is intended to connect a flow meter to the APU‑300 for performing maintenance work. Test probe, Ø 2.3 mm, for ARGON socket WA80012S The test probe is intended to be connected to the APU‑300 for performing maintenance work. Test pressure sensor cable, for pressure sensor socket WA80013S The test pressure sensor cable is intended to connect a flow meter to the APU‑300 for testing and calibrating the ESG‑300 system. Blockage tool, for test probe WA80014S The blockage tool is intended for leakage tests of the APU‑300 system. Load resistors WA80015S, WA80016S The load resistors are intended to perform peak voltage tests of the ESG‑300 system. Maintenance set, for ESG‑300 system WA80017S The maintenance set for the ESG‑300 system is intended for performing maintenance work on the ESG‑300 system.

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Safety information

2.1.1 Misuse Any use for other purposes than the intended use described above is considered as misuse. The manufacturer does not provide warranty for any damage to persons or to property due to misuse of the products. •• Do not use any accessories besides the ones described in these instructions for use and in the maintenance manual for the ESG‑300 system. •• Do not use any spare parts that are not approved by the manufacturer. •• Do not use the products in case of visible defects. •• Follow the cleaning and maintenance cycles. •• Do not exceed the maximum values of the supply media. •• Do not use the products after the specified life time is exceeded. •• Do not use the products while performing surgery with the ESG‑300 and APU‑300. The intended use and contraindications of the equipment used in combination with the products must be observed.

2.2 User qualification These products must only be used 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.

2.3 Environment of use These products are exclusively intended to be used for the annual safety check of the electrosurgical generator ESG‑300 and of the argon plasma coagulation unit APU‑300. The annual safety check must only be carried out in a technical laboratory with appropriate equipment.

2.4 General safety messages The following safety messages apply to the general handling of the products. This information is to be supplemented by the dangers, warnings and cautions given in the maintenance manual of the ESG‑300 system and in the instructions for use of any product being used with these products. Risks regarding improper use •• The products must be used by trained personnel only. •• Only use original spare parts. •• At the end of work, switch off any devices. •• Use the original fuses with the specified sizing only. Risks regarding electrical power •• Electrical work must only be performed by a qualified electrician. •• Only use approved and suitable tools and auxiliary means. When performing live work, use isolated tools according to EN60900 only. •• Before any cleaning, maintenance or troubleshooting work, disconnect the products from the power supply system. •• Observe the cleaning instructions. Do not use any fluids for cleaning.

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Safety information

•• Before connecting the products to the devices, make sure the electrical power supply of the devices is switched off. •• Before use, check all cables and connectors for damage. Only use undamaged products. Risks of injury due to tripping hazards or due to falling parts •• Place all cables and tubes in a way that prevents tripping over them. •• Do not place cables and tubes in areas of action or access. •• Do not place cables and tubes in a height that facilitates tripping. •• Do not place the products at the edge of the work table. Risks regarding gas pressure and leaking gas •• The pressure reducers must only be used for maintenance of the APU‑300. •• Only use the pressure reducers and the test probe in well ventilated places. •• Before each use, perform a check of all gas lines, of the test probe and of the blockage tool for damage and leak tightness. •• Before each use, make sure the connection of the pressure reducer has been properly established. Risks regarding high pressure Gas supply lines and assemblies may be pressurized. This may lead to sudden movements of hose lines that may cause crushing of body parts. •• Before work, depressurize the gas supply. Risks regarding electric shock The use of damaged electrical equipment can cause electric shock. •• Only use certified electrical equipment. •• Electrical work must only be performed by authorized and sufficiently qualified personnel. •• Before working on electrical systems, always obey the following safety rules: -- Switch off the electrical system and secure it against being switched on. -- Ensure the absence of voltage. -- Ground and short-circuit the system. -- Cover or block neighboring parts under voltage. •• Make sure that isolation of cables is undamaged over the entire length of the cables. •• Do not install the cables across sharp edges. If sharp edges occur, install an edge protection before routing the cables. •• Secure cables that are placed on the floor with firm cable ducts.

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Product description

3 Product description 3.1 Scope of delivery This chapter specifies the scope of delivery of the items according to their catalog numbers. Each item is delivered with these instructions for use. •• 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. WA80003S: Simulator, for foot switch WA80004S: Simulator, for sparks WA80005S: Test cable, for ARGON socket WA80006S: Pressure reducer, adjustable, 0-10 bar, DIN 477-6 WA80007S: Pressure reducer, adjustable, 0-10 bar, DIN 477-10 WA80008S: Pressure reducer, adjustable, 0-10 bar, CGA 580 WA80009S: Pressure reducer, adjustable, 0-10 bar, BS 341-3 WA80010S: Pressure reducer, adjustable, 0-10 bar, JIS B8246 WA80011S: Test hose, for argon connector WA80012S: Test probe, Ø 2.3 mm, for ARGON socket WA80013S: Test pressure sensor cable, for pressure sensor socket WA80014S: Blockage tool, for test probe WA80015S: Load resistor, 3000 Ω WA80016S: Load resistor, 4000 Ω WA80017S: Maintenance set, for ESG‑300 system, consisting of: -- WA80003S Simulator, for foot switch -- WA80004S Simulator, for sparks -- WA80005S Test cable, for ARGON socket -- WA80011S Test hose, for argon connector -- WA80012S Test probe, Ø 2.3 mm, for ARGON socket -- WA80013S Test pressure sensor cable, for pressure sensor socket -- WA80014S Blockage tool, for test probe

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Product description

3.2 Simulator, for foot switch WA80003S

1) Foot switch plug 2) Power switch The foot switch simulator is used for simulating a foot switch when testing and calibrating the ESG‑300 system. -- The foot switch plug connects the simulator to the ESG‑300. -- When switching on the power switch, activation of the coagulation pedal of a foot switch can be simulated.

3.3 Simulator, for sparks WA80004S

1) Red connector 2) Black connector The sparks simulator simulates sparking voltage when performing a functional test of the ESG‑300 system. -- The red connector connects the simulator to the test cable for ARGON socket. -- The black connector connects the simulator to a communication cable with banana plugs.

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Product description

3.4 Test cable, for ARGON socket WA80005S

1) Plug for ARGON socket 2) Banana plug The test cable is intended to connect the APU‑300 to the sparks simulator for functional tests of the ESG‑300 system. -- The plug connects the test cable to the ARGON socket of the APU‑300. -- The banana plug connects the test cable to the red connector of the sparks simulator.

3.5 Pressure reducers, adjustable, 0-10 bar WA80006S, WA80007S, WA80008S, WA80009S, WA80010S

1) 2) 3) 4) 5) 6)

Gas hose Outlet pressure gauge Input pressure gauge Gas cylinder connector (region specific) Pressure regulator Quick release coupling

The adjustable pressure reducer is used for testing and calibrating the APU‑300. -- The gas cylinder connector connects the pressure reducer to an argon gas cylinder.

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Product description

-- The quick release coupling connects the pressure reducer to the APU‑300 or to a flow meter. -- The pressure regulator adjusts the outlet pressure that is needed for the respective test. -- The input pressure gauge displays the pressure of the argon gas cylinder. -- The outlet pressure gauge displays the outlet pressure of the pressure reducer. Depending on the country or region where the pressure reducer is used it distinguishes by the design of the gas cylinder connector: -- WA80006S: Pressure reducer with connector according to DIN 477-6 -- WA80007S: Pressure reducer with connector according to DIN 477-10 -- WA80008S: Pressure reducer with connector according to CGA 580 -- WA80009S: Pressure reducer with connector according to BS 341-3 -- WA80010S: Pressure reducer with connector according to JIS B8246

3.6 Test hose, for argon connector WA80011S

1) 2) 3) 4) 5)

Protection cap Flow meter connector Gas hose Protection cap APU‑300 connector

The test hose is used for testing and calibrating the APU‑300. -- The flow meter connector connects the test hose to a flow meter. -- The APU‑300 connector connects the test hose to the argon connector on the rear panel of the APU‑300. -- The protection caps protect the connectors against dirt during transport and storage.

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Product description

3.7 Test probe, Ø 2.3 mm, for ARGON socket WA80012S

1) Outlet 2) Plug for ARGON socket The test probe is used for testing and calibrating the APU‑300. -- The plug connects the test probe to the APU‑300. -- The outlet is connected to the blockage tool. Replace the test probe for ARGON socket after 50 mating cycles.

3.8 Test pressure sensor cable, for pressure sensor socket WA80013S

1) Flow meter plug 2) Pressure sensor plug The test pressure sensor cable is used for testing and calibrating the APU‑300. -- The flow meter plug connects the cable to a flow meter. -- The pressure sensor plug connects the cable to the pressure sensor socket of the APU‑300.

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Product description

3.9 Blockage tool, for test probe WA80014S

1) Screw plug The blockage tool blocks the outlet of the test probe and is used for the leakage test of the APU‑300. -- The screw plug connects the blockage tool to the outlet of the test probe.

3.10 Load resistors WA80015S, WA80016S

1) Red connector 2) Black connector The load resistors are used to perform peak voltage tests of the ESG‑300 system. -- The red connector connects the load resistor to the ESG‑300. -- The black connector connects the load resistor to an electrosurgical analyzer. Depending on the test, load resistors with different resistances are needed: -- WA80015S: load resistor, 3000 Ω

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Product description

-- WA80016S: load resistor, 4000 Ω

3.11 Maintenance set, for ESG‑300 system WA80017S The maintenance set for the ESG‑300 system contains the following products which are described above: -- WA80003S -- WA80004S -- WA80005S -- WA80011S -- WA80012S -- WA80013S -- WA80014S

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

Explanation

Symbol

Explanation

Catalog number ​

Keep away from rain. Keep dry

Serial number

Caution, consult accompanying documents

Quantity of content

CE certification mark

Manufacturer

Date of manufacture

3.13 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.

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Use

4 Use The products are used for the annual safety check of the electrosurgical generator ESG‑300 and the argon plasma coagulation unit APU‑300. •• For detailed information on performing the safety check refer to the maintenance manual of the ESG‑300 system.

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Maintenance

5 Maintenance 5.1 Cleaning Cleaning must be performed quarterly. •• Use a soft and lint-free cloth. •• Do not use liquids of any kind when cleaning electrical equipment and cables. •• Do not use any aggressive cleaning agents when cleaning the pressure reducers and gas hoses. Appropriate cleaning agents are: -- alkaline agents, max. pH value of 12.0 -- neutral detergents

5.2 Visual inspection A visual inspection must be performed annually. •• Check that the product has: -- no dents, cracks, kinks, or deformations, -- no deep scratches, -- no corrosion, -- no missing or loose parts. •• Check all markings on the product for clear visibility. •• For WA80007S, WA80008S, WA80010S: Check the O-rings in the gas cylinder connections for damage.

5.3 Functional test of the sparks simulator A functional test of the sparks simulator (WA80004S) must be performed annually. •• Refer to the maintenance manual for the ESG‑300 system.

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Packaging, transport and storage

6 Packaging, transport and storage 6.1 Packaging and transport For packaging and transport, observe the following instructions: •• If possible, use the original cardboard packaging for the transport of the product. •• Wrap each product individually to prevent abrasion and impact during transport. •• Pack the products dry and in a watertight package.

6.2 Storage •• If possible, store the products in the original cardboard packaging. •• Observe the storage conditions in the section “Ambient conditions” on page 25.

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Repair, shipment and disposal

7 Repair, shipment and disposal 7.1 Repair There is no repair service. •• Do not send the product to Olympus for repair. •• Do not attempt to repair or modify the product.

7.2 Shipment When sending products to an authorized service center for warranty claims, note the following. Risk of infection Used products represent a risk of infection for the servicing personnel. Service centers are entitled to refuse repairs of soiled or contaminated products for reasons of safety. •• Thoroughly clean the products before sending in. Packaging •• Use the original cardboard packaging for the transport of the product. •• If this is not possible, wrap each component individually in sufficient paper or sheets of foamed material and place them in a cardboard box. Service centers do not accept warranty claims for damage caused by inadequate packaging.

7.3 Disposal When disposing of the product or any of its components, follow all applicable national and local laws and guidelines.

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Ordering information

8 Ordering information Product designation Simulator, for foot switch Simulator, for sparks Test cable, for ARGON socket Pressure reducer, adjustable, 0-10 bar, DIN 477-6 Pressure reducer, adjustable, 0-10 bar, DIN 477-10 Pressure reducer, adjustable, 0-10 bar, CGA 580 Pressure reducer, adjustable, 0-10 bar, BS 341-3 Pressure reducer, adjustable, 0-10 bar, JIS B8246 Test hose, for argon connector Test probe, Ø 2.3 mm, for ARGON socket Test pressure sensor cable, for pressure sensor socket Blockage tool, for test probe Load resistor, 3000 Ω Load resistor, 4000 Ω Maintenance set, for ESG‑300 system

Catalog number WA80003S WA80004S WA80005S WA80006S WA80007S WA80008S WA80009S WA80010S WA80011S WA80012S WA80013S WA80014S WA80015S WA80016S WA80017S

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Technical data

9 Technical data 9.1 Specifications 9.1.1 Simulator, for foot switch (WA80003S) Size Width...112 mm Height...37 mm Depth...62 mm Weight... 0.3 kg Cable length...1500 mm Electrical data Nominal voltage... 5 V DC Nominal current... 10 mA Protection class (housing)... IP 54 Expected service life WA80003S... 10 years 9.1.2 Simulator, for sparks (WA80004S) Size Width...65 mm Height...37 mm Depth...50 mm Weight... 0.2 kg Electrical data Nominal voltage... 120 V Nominal current... ≤ 15 mA Nominal frequency...300 kHz to 600 kHz Protection class (housing)... IP 65 Expected service life WA80004S... 10 years 9.1.3 Test cable, for ARGON socket (WA80005S) Size Weight... 0.2 kg Cable length...1000 mm Electrical data Nominal voltage... 3500 V Nominal current... 1.12 A Nominal frequency...500 kHz Expected service life WA80005S... 10 years

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