Macro hanpieces Model 94-10x Instructions for Use R03.01 April 2015

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Table of contents

Table of contents

1 Introduction ... 5 1.1

Information about these instructions for use... 5

1.2

Typographical conventions ... 5

1.3

General conditions... 6

2 Safety ... 7 2.1

Intended use... 7

2.2

General warnings ... 8

3 Overview...11 3.1

Overview of macro handpiece ...11

3.2

Scope of delivery...12

3.3

Symbols ...13

3.4

System overview ...14

4 Transport and storage...15 5 Operation ...16 5.1 5.1.1 5.1.2

Preparing for treatment ...16 Connecting the macro handpiece to the ultrasonic generator...17 Functional testing ...19

5.2

Starting treatment ...20

5.3 5.3.1

Ending treatment...23 Disconnecting the macro handpiece from the ultrasonic generator.23

6 Reprocessing ...25 6.1

Disassembling the macro handpiece ...25

6.2

Manually pre-cleaning the macro handpiece ...26

6.3

Automatically cleaning and disinfecting the macro handpiece .27

6.4

Reassembling the macro handpiece ...28

6.5

Sterilizing the macro handpiece...29

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Table of contents

7 Preventive maintenance ...30 7.1

Faults...31

7.2

Safety check...31

7.3

Preventive maintenance ...32

7.4

Repairs ...32

8 Disposal ...33 9 Technical data ...34 Index ...35

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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 macro handpiece optimally. The assembly and disassembly of the macro handpiece and the reprocessing after use are described in detail. Medical application is not described. Find out about the medical applications and their side effects. The relevant information can be found in the specialist literature. These instructions for use are included with the macro handpiece. Please read the instructions for use completely before using the macro handpiece. Please keep these instructions for use for future reference. The macro handpiece is only approved for use with a Söring ultrasonic generator and Söring accessories. Please also observe the instructions for use for the ultrasonic generator and the accessories that are used. If you have further questions on the content of these instructions for use or use of the macro handpiece, please contact Söring GmbH (contact data on back page) or an authorized distributor.

1.2 Typographical 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 severe injury. This could result in death or severe injury. This could result in minor injury. This could result in material damage.

All warning information is structured according to the same model. The source of the hazard is stated after the signal word. Then the effects of the hazard and its consequences are described. Finally the steps that must be taken to eliminate the hazard are given.

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Introduction General conditions

1.3 General conditions Ensure that the following conditions are met when working with the macro handpiece: 

The instructions for use must be read before the macro handpiece can be used.



The macro handpiece must be processed according to the instructions given in these instructions for use before it can be used for the first time (see chapter ”Reprocessing” on page 25).



Report any recurring faults or problems to Söring GmbH or an authorized distributor.

Söring GmbH accepts no liability for any damage or personal injury arising from: 

modifications or manipulations of the macro handpiece



improper use



use of an unauthorized ultrasonic generator,



use of accessories other than the recommended ones,



Improper handling



non-compliance with these instructions for use.

1.4

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Safety Intended use

2 Safety 2.1 Intended use The macro handpiece is solely intended for open liver resection and partial liver resection on humans. The macro handpiece is used for selective dissection of liver tissue. The macro handpiece is not intended for use directly on the heart, the eye or the central nervous system. For the desired tissue effect to be achieved with the macro handpiece, sufficient irrigation solution must be used. Only physiological saline solution or Ringer's solution is approved as an irrigation solution. As no definitive information is available for the treatment of at risk patients – primarily pregnant women and hemophiliacs – the attending surgeon must weigh the risks of the treatment particularly carefully against the benefits. In each case, the surgeon providing treatment is responsible for weighing the risks of treatment against the benefits. The macro handpiece may only be used in inpatient and outpatient medical rooms. In close vicinity to the operating field, the atmosphere must not be oxygen enriched nor must there be any danger of explosion. Only qualified surgeons may operate on patients with the macro handpiece. Any other use in accordance with the intended use – e.g. for operation and reprocessing – is only permitted for qualified specialists such as OP staff, sterilization department staff and surgical assistants possessing the required education, training or knowledge as well as sufficient experience. In general, a macro handpiece may only used by persons properly instructed in its handling. The manufacturer or a person authorized by the operator must provide instruction in the handling of the macro handpiece with the help of these instructions for use. The macro handpiece is authorized for use with the following Söring ultrasonic generators only: 

SONOCA 300



SONOCA 400.

Under normal conditions, the macro handpiece is intended for use of no longer than 60 minutes in total. The specified ambient temperature, relative humidity and air pressure conditions must be maintained at all times during operation as well as during transport and storage. The local health and safety at work, hygiene and safety regulations and the specifications in these instructions for use and the instructions for use of the ultrasonic generator used must be complied with. Any use other than that specified is considered to be improper use.

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Safety General warnings

2.2 General warnings

Improper use on the central nervous system The use of the macro handpiece on the central nervous system would have incalculable consequences. 

Only use the macro handpiece as intended for liver resection or partial liver resection.

Electromagnetic fields Electromagnetic fields such as can be created by a magnetic resonance tomograph can affect the function of the macro handpiece and severely injure patients. 

Do not use the macro handpiece within the range of electromagnetic fields.



Ensure electromagnetic compatibility of other electrical devices.



Only use medical electrical devices that have a CE mark with identification number of the notified body.

Contaminated macro handpiece Use of a contaminated macro handpiece may result in life-threatening infections in both patients and users.

8



Only use a sterile macro handpiece.



Only use a sterile instrument cable.



Only use a sterile cover from undamaged packaging.



Only use a sterile double tubing from undamaged packaging.

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Safety General warnings

Damaged instrument cable Damaged insulation on the instrument cable may cause electric shock and result in severe injury or death. 

Check the instrument cable for damage.



If the instrument cable is damaged, immediately switch off the power supply (or do not switch it on).



Replace the instrument cable if damaged.



Only use an undamaged instrument cable.

Incorrect accessories Use of unauthorized accessories may lead to malfunctions and cause severe injury to patients as well as operators. 

Only use approved accessories (see catalogue or our website: www.soering.com).

Use outside of the specified ambient conditions Use of the macro handpiece outside the specified ambient temperature, relative humidity and air pressure conditions can have incalculable consequences. 

When operating the macro handpiece, ensure that the specified ambient conditions are maintained.



During transport and storage, ensure that the specified ambient conditions are maintained.

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Safety General warnings

Treatment of at risk patients The treatment of at risk patients may lead to death or severe injury. At risk patients include pregnant women and hemophiliacs.

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

Weigh the medical benefits of the treatment against the risks.



Prior to beginning treatment, ensure that all measures for lessening risks have been taken.

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Overview Overview of macro handpiece

3 Overview 3.1 Overview of macro handpiece 1

2

3

4 1

2 8 3 7

6

5

4

8 7

6

5

Fig. 3.1 Macro handpiece 1 2 3 4

Sonotrode Cover (disposable accessory) Nose cone Luer lock port for the aspiration

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Connector socket for the instrument cable Luer lock port for the irrigation Type designation and serial number Handpiece body with ultrasonic transducer

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Overview Scope of delivery

1

2 3

5

4

1

2

3 Fig. 3.2 Individual parts of macro handpiece 1 2 3

Sonotrode Small external irrigation tube Handpiece body with ultrasonic transducer

4 5

Nose cone Cover (disposable accessory)

3.2 Scope of delivery The macro handpiece is supplied without accessories. The following accessories are necessary for use of the macro handpiece: 

an instrument cable



a double tubing (disposable accessory)



a cover (disposable accessory).

Use only approved accessories. Approved accessories are listed in the catalogue. For the latest information regarding accessories, please visit our website: www.soering.com

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Overview Symbols

3.3 Symbols Standardized symbols are used in connection with the macro handpiece. In particular, the packaging of the required accessories is marked with these symbols. Pictogram

Meaning Indicates that the instructions for use must be read and followed. Indicates a medical device of type BF (Body Floating). Indicates a medical device with an article number in order to identify and reorder it. Indicates the batch of the medical device. Indicates who is the manufacturer of the medical device. Indicates when the medical device was manufactured. Indicates the date until which the medical device may be used. Indicates a medical device that may not be used if the packaging is damaged or already open. Indicates a medical device that has been sterilized with ethylene oxide. Indicates a medical device that must be stored in a dry place and protected from humidity. Indicates a medical device that must be protected from sunlight and light sources. Indicates the temperature to which the medical device can be safely exposed. Indicates a medical device that may not be reused and is only intended for single use on an individual patient during a single treatment.

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Overview System overview

3.4 System overview The macro handpiece is connected to an ultrasonic generator with irrigation and aspiration. A single foot switch on the ultrasonic generator is used for simultaneously activating the ultrasonic power and the irrigation and the aspiration.

1

INFORMATION

2 3 4

5

6 Fig. 3.3 Macro handpiece in the entire system 1 2 3

Ultrasonic generator Double tubing (disposable accessory) Instrument cable

4 5 6

Macro handpiece Cover (disposable accessory) Single foot switch

3.5

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Transport and storage

4 Transport and storage For transport and storage of the macro handpiece, use packaging which protects it against damage and contamination. Always store the sterilized macro handpiece in sterile packaging in accordance with ISO 11607. The storage environment must be dry, clean and dust-free. 

Storage temperature: between –25 °C and 70 °C (–13 °F and 158 °F).



Relative humidity: between 10 % and 95 %, non-condensing



Air pressure: between 500 hPa and 1060 hPa (7.25 psi and 15.37 psi)

4.1

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Operation Preparing for treatment

5 Operation Only qualified surgeons may operate on patients with the macro handpiece. Any other use of the macro handpiece in accordance with the intended use is only permitted for qualified specialists. The surgeon providing treatment is responsible for weighing the risks of treatment against the benefits. Prior to the first treatment – and prior to any further treatment – the macro handpiece and the instrument cable must be cleaned, disinfected and sterilized (see chapter ”Reprocessing” on page 25). Please also observe the instructions for use supplied with the ultrasonic generator. They contain information regarding the assembly of the required accessories and the connection of the macro handpiece to the ultrasonic generator. Functional testing must always be carried out on the ultrasonic generator with the macro handpiece prior to treatment (see section ”Functional testing” on page 19). Please also observe the instructions for use supplied with the ultrasonic generator when carrying out this test. After treatment, properly dispose of the cover and the double tubing. The macro handpiece and the instrument cable must be reprocessed (see chapter ”Reprocessing” on page 25).

5.1 Preparing for treatment First the macro handpiece must be connected to the ultrasonic generator. A visual inspection must then be carried out. Finally, functional testing must be carried out and the power settings on the ultrasonic generator checked. Only then may treatment be started.

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Operation Preparing for treatment 5.1.1 Connecting the macro handpiece to the ultrasonic generator Requirements 

The macro handpiece is sterile.



The instrument cable is sterile.



A sterile cover is at hand.



An irrigation bottle, an aspiration canister and a sterile double tubing are at hand.



The ultrasonic generator is turned on.

Procedure 1. During a visual inspection, ensure that the handpiece body, the sonotrode and the nose cone are in perfect condition. 2. Place the cover over the sonotrode and slide onto the nose cone.

Liquid on the contacts The connector socket may melt due to liquid on the contacts of a connector socket or the instrument cable. This leads to malfunctioning of the macro handpiece and of the ultrasonic generator. Treatment must be carried out with a redundant system, thereby lengthening the treatment duration. 

Make sure the contacts on the connector sockets and on the plugs are dry.



Observe the specified sequence of the steps so no liquid gets onto the contacts.

3. Insert the instrument cable plugs into the connector socket on the ultrasonic generator. Observe the markings. – The instrument cable engages in the connector socket.

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Operation Preparing for treatment 4. Insert the instrument cable plugs into the connector socket on the macro handpiece. Watch the markings.

– The instrument cable engages in the connector socket. – The OK indicator light on the ultrasonic generator lights. 5. Connect the double tubing with the luer lock ports of the macro handpiece. Hand tighten only. Observe the instructions for use of the ultrasonic generator for using the irrigation bottle and the aspiration canister.

– The macro handpiece is connected to the ultrasonic generator.

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Operation Preparing for treatment 5.1.2 Functional testing Functional testing must always be carried out on the ultrasonic generator with the macro handpiece prior to treatment. The irrigation function and the ultrasonic function are checked during the functional testing and the suctioning function. Finally, the power settings on the ultrasonic generator must be checked and adjusted. The ultrasonic power and the aspiration capacity and the irrigation capacity must be ensured. Requirements 

The macro handpiece has reached the permissible temperature for use (between 10 °C and 40 °C (50 °F and 104 °F)).



The macro handpiece is connected to the ultrasonic generator.



The OK indicator light on the ultrasonic generator lights.

Procedure 1. Press and hold the button on the ultrasonic generator for filling with irrigation solution until irrigation solution exits from the sonotrode on the macro handpiece and there is no more air trapped in the double tubing. 2. Ensure the connections between the double tubing and macro handpiece and between the double tubing and irrigation bottle do not leak. 3. Activate the macro handpiece with the foot switch and immerse the sonotrode in sterile liquid. – The sterile liquid begins to make a noise; this is a sign that ultrasonic power is supplied. 4. Release the foot switch. – The aspiration pump continues to run for another 30 seconds. 5. As long as the aspiration pump continues to run, immerse the sonotrode in sterile liquid again. – The liquid is suctioned off which is visible in the transparent part of the double tubing. – Functional testing has been carried out. 6. Check and adjust the irrigation capacity on the ultrasonic generator. 7. Check and adjust the ultrasonic power on the ultrasonic generator. 8. Check and adjust the aspiration capacity on the ultrasonic generator. – All power settings have been adjusted. – Treatment can be carried out.

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Operation Starting treatment

5.2 Starting treatment A single foot switch on the ultrasonic generator is used for simultaneously activating the ultrasonic power and the irrigation and the aspiration. It is crucial for the treatment result that the power settings are correct, in particular for the ultrasonic power and the aspiration capacity. The tissue effect is controlled primarily with the ultrasonic power and the aspiration capacity. higher the ultrasonic power and the aspiration capacity is set, the stronger the tissue effect. Always begin the treatment with a low ultrasonic power to prevent an unintentionally strong effect. Then slowly increase the ultrasonic power. For the desired tissue effect to be achieved with the macro handpiece, sufficient irrigation solution must be used. Only physiological saline solution or Ringer's solution is approved as an irrigation solution. Irrigation bottles with 500 ml content are recommended. Only when sufficient irrigation solution is directed to the sonotrode tip will the sonotrode tip not clog. Sufficient irrigation solution also prevents the macro handpiece becoming excessively hot when activated for a long time. Thus check the sonotrode tip continuously over the course of the treatment to determine that it is being supplied with sufficient irrigation solution. For the irrigation solution to be aspirated again, the aspiration capacity must be set accordingly high. Sufficient irrigation solution is important to achieve the desired tissue effect. However, too much irrigation solution can impair the view of the operating field. The irrigation solution must be aspirated. Do not set the aspiration capacity too low, instead increase the irrigation capacity in order to prevent the sonotrode and the double tubing from blocking. Due to the friction heat, it is also crucial for the treatment result that the correct pressure is applied to the tissue and the movement of the sonotrode tip is correct over the tissue. Always use the macro handpiece with care so the sonotrode is not damaged. Do not bend the sonotrode or touch any metal objects with it. Observe the course of the instrument cable and the double tube during the treatment. The staff must not be impeded. They could fall and patients be injured by the sudden movement from the fall.

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Operation Starting treatment

Contaminated macro handpiece Use of a contaminated macro handpiece may result in life-threatening infections in both patients and users. 

Only use a sterile macro handpiece.



Only use a sterile instrument cable.



Only use a sterile cover from undamaged packaging.



Only use a sterile double tubing from undamaged packaging.

Metal objects in the vicinity of the sonotrode Contact of the sonotrode with metal objects can cause sparking. This may result in explosions and fires. The sonotrode can also be damaged, in turn leading to the possibility of severe injury to patients. 

Do not touch any metal objects with the sonotrode.



Do not use anaesthetic gas or oxygen in the immediate vicinity of the operating field.



Do not use any explosive or flammable materials in the immediate vicinity of the operating field.

Hot sonotrode The sonotrode can heat up during the operation. Contact with the hot sonotrode can damage tissue, even if the macro handpiece is not activated. 

Do not touch tissue that is not to be operated on with the sonotrode.

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