SONOCA 300 Instructions for Use Release 03.01 Nov 2018

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Table of contents

Table of contents

1 Introduction ... 6 1.1

Information about these instructions for use... 6

1.2

Display conventions ... 6

2 Safety ... 7 2.1

Intended use... 7

2.2

Indications and side effects... 8

2.3

Compatibility... 8

2.4

Selection and qualification of specialist staff... 9

2.5

Treatment environment ... 9

2.6

Treatment duration ...10

2.7

High-risk patients ...10

2.8

Handling the cables and accessories...10

2.9

Prohibition and warning signs...11

2.10

Penetrating liquid ...11

2.11

Modifications or manipulation ...11

2.12

High-frequency current ...11

3 Overview...12 3.1

Overview of ultrasonic generator...12

3.2

Functional description...14

3.3 3.3.1 3.3.2 3.3.3 3.3.4

Buttons and displays ...15 Operator control panel for aspiration...15 Operator control panel for ultrasonic power ...16 Operator control panel for irrigation ...16 Display panel...17

3.4

Scope of delivery...17

3.5

Accessories ...18

3.6

Serial plate...18

3.7

Symbols ...19

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Table of contents

4 Transportation and storage ...20 5 Installation ...21 5.1

Performing a visual inspection ...21

5.2

Connecting the ultrasonic generator to the supply network...21

5.3

Connecting the foot switch ...21

5.4

Preparing aspiration...22

5.5

Preparing irrigation ...23

5.6

Switching on the ultrasonic generator...24

6 Operation ...25 6.1 6.1.1 6.1.2 6.1.3 6.1.4

Preparing for treatment ...25 Connecting the instrument... 25 Connecting the tubing to the irrigation bottle... 25 Connecting the tubing to the aspiration canister... 27 Functional testing... 27

6.2 6.2.1 6.2.2

Starting treatment ...28 Adjusting power settings... 28 Treatment with the instrument ... 28

6.3 6.3.1

Ending treatment...29 Switching off the ultrasonic generator and disconnecting it from the supply network... 29 Disconnecting the instrument from the ultrasonic generator... 29 Disconnecting the foot switch ... 29 Detaching the aspiration canister... 29 Detaching the irrigation bottle... 29

6.3.2 6.3.3 6.3.4 6.3.5

7 Cleaning and disinfecting ...30 7.1

Cleaning and disinfection requirements ...30

7.2

Cleaning and disinfecting the ultrasonic generator and accessories ...30

8 Troubleshooting ...31 8.1

Faults occurring during the self-test ...31

8.2

Faults occurring during operation ...32

9 Maintenance...34

4

9.1

Inspection ...34

9.2

Maintenance...34

9.3

Repairs ...34

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Table of contents

10 Disposal ...36 11 Technical data ...37 12 Electromagnetic compatibility ...38 Index ...39

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Introduction Information about these instructions for use

1 Introduction 1.1 Information about these instructions for use These instructions for use are intended to help you use the ultrasonic generator correctly. Emphasis is placed on the installation, start-up and safe use of the ultrasonic generator. Medical application is not described. These instructions for use come with the ultrasonic generator. Read the instructions for use thoroughly before using the ultrasonic generator. Keep these instructions for use for future reference. The ultrasonic generator is only approved for use with a Söring instrument and accessories specified by Söring. For this reason, please also follow the instructions for use of the instrument and the accessories that are used. If you have further questions on the content of these instructions for use or use of the ultrasonic generator, please contact Söring GmbH (contact data on back page) or an authorized distributor.

1.2 Display conventions In these instructions for use, warnings are indicated by a signal word. Hazards are categorized into hazard levels with consequences of differing severity. Signal word

Consequences This will result in death or serious harm to health. This could result in death or serious harm to health. This could result in slight harm to health. This could result in material damage.

All warnings are structured according to the same pattern. The type of hazard is listed after the signal word. Then the consequences that may result from the hazardous situation are described. Finally, there is a description of how to avoid the hazardous situation. Chapters with safety-relevant information are identified by the following symbol:

1.3

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Safety Intended use

2 Safety This chapter contains information about the ultrasonic generator. It explains what you have to know and take into consideration before use. Reading it also helps to increase your safety awareness. Prior to using the ultrasonic generator, make sure to also observe the safety-relevant information in the instructions for use for the instrument and accessories.

2.1 Intended use The ultrasonic generator is intended solely for use in ultrasonic surgery on humans. During operation, the ultrasonic generator temporarily supplies energy to a connected instrument in a controlled manner. It also provides an irrigation function and a suctioning function. The precise medical purpose is determined by the instrument connected. The ultrasonic generator is suitable for the following applications: 

Selective tissue dissection



Mechanical removal and cutting of bones



Wound debridement and wound cleansing



Tissue cutting



Tissue coagulation

It is not intended for use directly on the eyes or the central circulatory system. Any use other than that specified is considered improper. Any non-intended use can have serious consequences. These consequences can affect you as well as the patient and anyone else who comes into contact with the ultrasonic generator or with a connected instrument.

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Safety Indications and side effects

2.2 Indications and side effects The indicators inform you about which instruments need to be connected. Side effects due to the surgical technique may occur during the course of treatment. The following side effects are known: 

The tissue absorbs ultrasonic energy, which may damage underlying layers of tissue.



The cavitation effect widens, which may damage underlying layers of tissue.



The sonotrode tip heats up, which may have an unintended tissue effect on contact with tissue.

You can obtain information on the risks and side effects of the specific surgical techniques from specialist groups and the literature. Provide your patients with information about the risks and side effects related to treatment.

2.3 Compatibility The ultrasonic generator may only be used with a compatible instrument from Söring and compatible accessories. The use of incompatible instruments or accessories can have serious consequences. These consequences can affect you as well as the patient and anyone else who comes into contact with the instrument or accessories. Instrument Whether you may use an instrument with the ultrasonic generator is specified in the instructions for use of the instrument. The instructions for use of the instrument also specify which accessories are compatible with the instrument. Foot switch The following foot switches are compatible with the ultrasonic generator: 

Foot switch 770S0001



Foot switch 770S0009



Foot switch 770S0013



Foot switch 770S0016

Aspiration canister and aspiration liner The aspiration systems – consisting of aspiration canister and aspiration liner – from e. g. Medela and Serres are compatible with the ultrasonic generator. The aspiration system must have the following features:

8



The volume may be no more than 3,000 ml.



The aspiration system must have overflow protection.

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Safety Selection and qualification of specialist staff Cart The following cart is compatible with the ultrasonic generator: 

Cart 700S0123

2.4 Selection and qualification of specialist staff The ultrasonic generator may only be used by personnel properly instructed in its handling. The manufacturer, authorized distributor or a person authorized by the operator (and trained by either the manufacturer or an authorized distributor) must provide instruction in handling the ultrasonic generator with the help of these instructions for use. Only qualified and trained physicians may treat patients using instruments connected to the ultrasonic generator. Only UAW instruments may also be used by qualified nursing staff to perform wound debridement or wound cleansing. Any other intended use – for installation and operation – is only permitted for qualified specialist personnel with the required training or knowledge, and sufficient experience.

2.5 Treatment environment The ultrasonic generator may only be used in rooms used for medical purposes. The ultrasonic generator may only be connected to a supply network that does not also supply residential buildings. In the immediate vicinity of the instrument and the ultrasonic generator, the atmosphere must not be oxygen-enriched, there must be no flammable substances and no danger of explosion. The ultrasonic generator may not be used in areas under the influence of magnetic or electromagnetic fields. Electromagnetic fields, such as those generated by MRI scanners, can influence the function of the ultrasonic generator. For this reason, ensure the electromagnetic compatibility of other electrical devices. Only use medical electrical equipment that meets the electromagnetic compatibility requirements of IEC 60601-1-2. However, these devices should not be placed on, under or directly next to the ultrasonic generator. This recommendation also applies to the use of a high-frequency generator. If no separate arrangement is possible, you must ensure that everything is working properly during treatment. Communication devices must be at a distance of at least 30 cm away from the ultrasonic generator and its accessories. The specified ambient temperature, humidity, and air pressure conditions must be maintained at all times so that the ultrasonic generator does not fail.

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Safety Treatment duration

2.6 Treatment duration The ultrasonic generator may not be activated for longer than 60 minutes total within an 80-minute period.

2.7 High-risk patients The treatment of high-risk patients can lead to death or cause serious harm to health. High-risk patients can include pregnant women and hemophiliacs, but also infants and children under the age of 14. As the physician providing treatment, you are responsible for weighing the risks of treatment against the benefits in each case.

2.8 Handling the cables and accessories All cables and accessories must be in perfect condition. Only use cables and accessories from Söring to avoid malfunctions and injuries. The cables may not be kinked or crushed, to prevent damage to the insulation. To disconnect a cable, pull on either the grip sleeve or the plug.

Fig. 2.1 Pulling the grip sleeve

Electrical shock due to damaged or worn cable insulation may result in serious injury, burns, death, as well as fire.

10



Check each cable for damage.



If a cable is damaged, immediately switch off the power supply.



Replace any damaged cables.

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Safety Prohibition and warning signs During treatment, make sure the cables and tubing are positioned so nobody stumbles over them, since any abrupt movement when stumbling can cause injuries to the patient.

2.9 Prohibition and warning signs The following prohibition and warning signs have been affixed to the ultrasonic generator. Warning sticker

Meaning Read the instructions for use High voltage warning Hazardous area warning Risk of entanglement warning

2.10 Penetrating liquid No liquid may be allowed to penetrate the ultrasonic generator. Penetrating liquid may result in electric shock and cause serious injury or death. For this reason, ensure that no liquid comes into contact with the ultrasonic generator. Use a damp cloth for cleaning, not a wet sponge.

2.11 Modifications or manipulation The ultrasonic generator and accessories may not be modified or tampered with. Modifications or manipulation can have serious consequences. These consequences can affect you as well as the patient and anyone else who comes into contact with the ultrasonic generator or accessories.

2.12 High-frequency current Do not apply any high-frequency output voltage to the connected instrument, e.g., by touching the instrument with a monopolar instrument.

2.13

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Overview Overview of ultrasonic generator

3 Overview 3.1 Overview of ultrasonic generator 5

1

11

2

3

10

6

4

9

8

7

Fig. 3.1 Front side 1 2 3 4 5 6

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Operator control panel for aspiration Operator control panel for ultrasonic power Operator control panel for irrigation Display panel Irrigation holder Irrigation bottle (accessory)

7 Aspiration canister (accessory) 8 Irrigation pump 9 Connector socket for an instrument 10 Connector socket for a foot switch 11 Power switch

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Overview Overview of ultrasonic generator

1

2

3

Emergency Vacuum Vacuum

9

Emergency Pumpswitch

Netzanschluß Power Cord

- Lautstärke + - Volume +

8

7

6

5

4

Fig. 3.2 Rear side 1 2 3 4 5

Connector socket for the power cord Connector socket for the suction source tubing Serial plate Loudspeaker Volume control

1

6 7 8 9

Bracket for the air filter Air filter Connection for the potential equalization cable Fuse holder

2

3

Fig. 3.3 Left side 1 2 3

Irrigation pump Mount for the aspiration canister Mount tube for irrigation holder

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Overview Functional description

3.2 Functional description The ultrasonic generator can be operated at three different working frequencies (25 kHz, 35 kHz and 55 kHz) to perform different types of treatments. The working frequency is determined by the instrument used and cannot be changed. The ultrasonic generator detects the connected instrument. As soon as an instrument is connected, the ultrasonic generator loads the instrument-specific power settings for ultrasonic power, irrigation, and aspiration. The power settings must be adjusted on the operator control panels according to the requirements of the treatment. As soon as an instrument is connected, the indicator for instrument activity lights up and an activation tone sounds, indicating that ultrasonic power is being output. The volume of the activation tone can be set using the volume control. The setting has no effect on the volume of the alarm tones. Instruments with irrigation and aspiration Instruments using irrigation and aspiration are activated by a foot switch. The indicator for instrument activity lights up when an instrument is activated. Irrigation and aspiration is activated at the same time as ultrasonic power. When the instrument is activated, irrigation solution is routed from an irrigation bottle through the instrument. Tissue residue and fluid are simultaneously extracted and collected in an aspiration canister. As soon as you release the foot switch, ultrasonic power is cut and irrigation stops. Aspiration continues for another 30 seconds. Instruments with irrigation only Instruments with irrigation only are activated by a foot switch. The indicator for instrument activity lights up when an instrument is activated. Irrigation is activated at the same time as ultrasonic power. When the instrument is activated, irrigation solution is routed from an irrigation bottle through the instrument. As soon as you release the foot switch, ultrasonic power is cut and irrigation stops. Instruments only with aspiration Instruments only with aspiration are activated by a foot switch. The indicator for instrument activity lights up when an instrument is activated. Aspiration is activated at the same time as ultrasonic power. Tissue residue and fluid are extracted and collected in an aspiration canister. As soon as you release the foot switch, ultrasonic power is cut. Aspiration continues for another 30 seconds. Instruments entirely without irrigation or aspiration Instruments without irrigation and aspiration – e. g. ultrasonic scissors – are activated by a double foot switch. If the black pedal on the dual foot switch is depressed, the ultrasonic power set on the ultrasonic generator is output. Depressing the red pedal outputs the maximum possible ultrasonic power. The indicator for instrument activity lights up when an instrument is activated. As soon as you release the foot switch, ultrasonic power is cut.

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Overview Buttons and displays Instruments with high frequency current Instruments with high frequency current are operated in combination with a high-frequency generator. In this way, coagulation using high frequency current and using the effect of ultrasound can be activated alternately without having to change the instrument. Ultrasonic power is activated via a foot switch. The indicator for instrument activity lights up when an instrument is activated. Irrigation and aspiration is activated at the same time as ultrasonic power. When the instrument is activated, irrigation solution is routed from an irrigation bottle through the instrument. Tissue residue and fluid are simultaneously extracted and collected in an aspiration canister. As soon as you release the foot switch, ultrasonic power is cut and irrigation stops. Aspiration continues for another 30 seconds.

3.3 Buttons and displays 3.3.1 Operator control panel for aspiration You can adjust the aspiration capacity by increasing or reducing the set point for aspiration pressure on the operator control panel for aspiration. Aspiration pressure is shown on the operator control panel as a percentage of maximum aspiration pressure in bar on the display panel (see 3.3.4 Display panel on page 17). You can also switch off aspiration.

1 4

2 3

Fig. 3.4 Operator control panel for aspiration 1 2

Button for increasing aspiration pressure Button for switching on and off aspiration

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Button for reducing aspiration pressure Indicator light for aspiration pressure

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Overview Buttons and displays 3.3.2 Operator control panel for ultrasonic power You can increase and decrease ultrasonic power on the operator control panel for ultrasonic power. Alternatively, you can select ultrasonic power directly. You can still adjust ultrasonic power afterwards. The selected ultrasonic power is displayed. An indicator lights up as soon as an instrument becomes active.

5

1 4 2

3 Fig. 3.5 Operator control panel for ultrasonic power 1 2 3

Indicator for ultrasonic power Button for increasing ultrasonic power Button for decreasing ultrasonic power

4 5

Buttons for direct selection of ultrasonic power Indicator light for instrument activity

3.3.3 Operator control panel for irrigation You can adjust the irrigation capacity by increasing or reducing irrigation flow on the operator control panel for irrigation. The selected irrigation flow is shown on the operator control panel as a percentage of maximum irrigation flow and in millimeters per second on the display panel (see 3.3.4 Display panel on page 17). You can also fill tubing with irrigation fluid at the press of a button.

1 4

2 3

Fig. 3.6 Operator control panel for irrigation 1 2

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Button for increasing irrigation flow Button for filling the tubing

3 4

Button for reducing irrigation flow Indicator light for irrigation flow

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Overview Scope of delivery 3.3.4 Display panel You can call up a variety of information by pressing the buttons on the display panel. The following information can be displayed: 

Measured aspiration pressure [bar]



Working frequency of the instrument being used [kHz]



Irrigation flow [ml/min]



Instrument procedure time [min] since treatment was started

As soon as the ultrasonic generator is ready for use, the OK indicator light goes on. If a fault is detected during the power-on self test, a numeric code is displayed and the ERROR indicator light goes on. If the pressure of the sonotrode on the tissue is marginally high during treatment, the OK indicator light flashes; in this case the ultrasonic generator automatically reduces ultrasonic power. As soon as the pressure of the sonotrode on the tissue is too high, the ERROR indicator light goes on. The ERROR indicator light also goes on if a safety shutdown or a fault during operation has occurred.

5

1 2

4

3 Fig. 3.7 Display panel 1 2 3

Digital display The OK indicator light goes on when the ultrasonic generator is ready for use The ERROR indicator light goes on if a safety shut-down or a fault has occurred

4 5

Button for information display Type of information displayed

3.4 Scope of delivery The ultrasonic generator comes with the following accessories: 

A power cord



A potential equalization cable



Suction source tubing for the Medela aspiration system



Suction source tubing for the Serres aspiration system



An irrigation holder

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Overview Accessories

3.5 Accessories Performing treatment requires the following: 

An instrument



A foot switch



An aspiration canister with aspiration liner (when using aspiration)



A cart (optional)

In the system overview, refer to the respective instructions for use for the individual accessories you need in connection with a particular instrument.

3.6 Serial plate The serial plate is attached to the back of the ultrasonic generator.

4 1

5 6 7 8 9 10

2 3

11 12 13

Fig. 3.8 Serial plate 1 2 3 4 5 6 7

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Manufacturer Article number Classification of the applied part: Type BF (in accordance with IEC 60601-1) Type designation Serial number Date of manufacture Information about output voltage and frequency of the supply network

8 Power fuse 9 Maximum power consumption 10 Maximum activation time within 80 minutes 11 Maximum output power 12 Output frequency 13 In the USA: Treatment by a doctor only

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Overview Symbols

3.7 Symbols Symbol

Meaning Indicates that the instructions for use must be read and followed. Indicates a medical device of with an applied part of type BF according to IEC 60601-1). Indicates a medical device with an article number that enables it to be identified and reordered. Indicates a medical device with a serial number that enables it to be uniquely identified. Indicates the manufacturer of the medical device. Indicates when the medical device was manufactured. Indicates the use-by date of the medical device. Indicates a medical device that may not be used if the packaging is damaged or already open. Indicates a medical device that must be stored in a dry place and protected from moisture. Indicates a medical device that must be protected from sunlight and light sources.

1

Indicates how many items are in the packaging unit. Indicates the connector socket for a foot switch. Indicates the connector socket for an instrument. Indicates that high voltage is present on the connector socket. Indicates the connection for the potential equalization cable. Indicates that the medical device emits only non-ionizing radiation. Indicates that the medical device must not be disposed of in household waste.

3.8

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Transportation and storage

4 Transportation and storage For transportation and storage of the ultrasonic generator, use packaging which protects it from damage and contamination. The following conditions apply to storage and transportation: 

Temperature: between –20 °C (-4 °F) and 50 °C (122 °F).



Relative humidity: between 20% and 85%, non-condensing.



Air pressure: between 700 hPa (10.2 psi) and 1,060 hPa (15.3 psi).

4.1

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Installation Performing a visual inspection

5 Installation This chapter is aimed at personnel installing the ultrasonic generator. You will learn how to perform a visual inspection, connect the ultrasonic generator to the supply network and connect the accessories.

5.1 Performing a visual inspection Perform a visual inspection of the ultrasonic generator. Ensure that the ultrasonic generator and accessories are in perfect condition. Make sure that no cable is kinked or crushed and the insulation is not damaged.

5.2 Connecting the ultrasonic generator to the supply network Place the ultrasonic generator on a suitable surface. The surface must be adequately load-bearing and easily accessible, the Söring cart is suitable for this. Ensure that the ultrasonic generator is switched off before you connect the included power cord. The power switch must be set to 0.

Supply network without grounding conductor An electric shock resulting from the lack of a grounding conductor in the supply network may cause serious injury or death. 

Only connect the ultrasonic generator to a supply network with grounding conductor.

If several medical electrical devices are being used in the patient's surroundings the included potential equalization cable must be used and IEC 60601-1, chapter 16 followed. The potential equalization cable eliminates any potential differences between medical electrical devices in the patient's surroundings.

5.3 Connecting the foot switch Various foot switches can be used with the ultrasonic generator. The different foot switches are connected depending on the instrument used. The foot switch functions are determined by the connected instrument. For all instruments that are operated with irrigation, a single foot switch should be selected. If ultrasonic scissors are used, a dual foot switch should be selected.

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