UAW Handpieces 97-xxx Instructions for Use 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...10 3.1

Overview of UAW handpiece ...10

3.2

Scope of delivery...11

3.3

Symbols ...11

3.4

System overview ...12

4 Transport and storage...13 5 Operation ...14 5.1 5.1.1 5.1.2

Preparing for treatment ...15 Connecting the UAW handpiece to the ultrasonic generator ...15 Functional testing ...17

5.2

Starting treatment ...18

5.3 5.3.1

Ending treatment...20 Disconnecting the UAW handpiece from the ultrasonic generator ...20

6 Reprocessing ...22 6.1

Disassembling the UAW handpiece ...22

6.2

Manually pre-cleaning the UAW handpiece ...23

6.3

Automatically clean and disinfect the UAW handpiece...24

6.4

Reassembling the UAW handpiece...25

6.5

Sterilizing the UAW handpiece ...26

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Table of contents

7 Preventive maintenance ...27 7.1

Faults...28

7.2

Safety check...28

7.3 7.3.1

Preventive maintenance ...29 Lubricating the valve ... 29

7.4

Repairs ...30

8 Disposal ...31 9 Technical data ...32 Index ...33

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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 UAW handpiece in an optimum manner. The assembly and disassembly of the UAW 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 UAW handpiece. Please read the instructions for use completely before using the UAW handpiece. Please keep these instructions for use for future reference. The UAW 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 UAW 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 UAW handpiece: 

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



The UAW 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 22).



Any recurring faults or problems must be reported to Söring GmbH or an authorized distributor.

Söring GmbH does not accept liability for any damage or personal injury arising from: 

modification or manipulation of the UAW 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 UAW handpieces are intended exclusively for wound debridement and wound cleansing in humans. With the UAW handpieces fibrin tissue and biofilms can be effectively removed from chronic and acute wounds. The UAW handpiece may only ever be used on one patient. After treatment, it must be reprocessed to be sterile. The UAW handpiece is not intended for use on the central nervous system or the circulatory system. As no reliable findings pertaining to treatment of at risk patients – primarily pregnant women and hemophiliacs – are available the treating physician must weigh the risks of the treatment particularly carefully against the benefits. There is also no definitive information available regarding treatment of malignant tumors or use on the eye. In each case, the treating physician is responsible for weighing the risks of treatment against the benefits. The UAW handpiece may only be used in medical treatment rooms. In close vicinity to the UAW handpiece, the atmosphere must not be oxygen enriched nor must there be any danger of explosion. Only physicians and qualified care staff may treat patients using the UAW handpiece. Any other use of the UAW handpiece in accordance with the intended use – e.g. for operation and reprocessing – is only permitted for qualified specialists such as operating room staff, sterilization department staff and surgical assistants possessing the required education, training or knowledge as well as sufficient experience. In general the UAW handpiece may only be used by individuals properly instructed in its handling. The manufacturer or a person authorized by the operator must provide instruction in the handling of the UAW handpiece with the help of these instructions for use. The UAW handpiece is only approved for use with a Söring ultrasonic generator. Under normal conditions the UAW handpiece is intended for a procedure time during treatment 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

Electromagnetic fields Electromagnetic fields, such as those generated by a magnetic resonance tomograph, can influence the function of the UAW handpiece and cause severe injury to patients. 

Do not use the UAW handpiece in the area of influence 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 UAW handpiece Use of a contaminated UAW handpiece may result in life-threatening infections in both patients and users. 

Only use a sterile UAW handpiece.



Only use a sterile instrument cable.



Only use sterile irrigation tubing from undamaged packaging.

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

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

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.

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Safety General warnings

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

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



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

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. 

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 UAW handpiece

3 Overview 3.1 Overview of UAW handpiece 1 2 3 4 8 11

10

7

9

6

5

Fig. 3.1 UAW handpiece 1 2 3 4 5 6

Sonotrode Nose cone Valve for controlling irrigation (open) Luer lock port for the irrigation tubing Connector socket for the instrument cable Type designation and serial number

7 Handpiece body with ultrasonic transducer 8 Long double-ball sonotrode tip 97-112 9 Long double-ball sonotrode tip 97-102 10 Hoof sonotrode tip 97-103 11 Spatula sonotrode tip 97-104

1 2

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

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Nose cone Sonotrode Handpiece body with ultrasonic transducer

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Overview Scope of delivery

3.2 Scope of delivery The UAW handpiece is delivered without other accessories. For the use of the UAW handpiece, the following accessories are necessary: 

an instrument cable



irrigation tubing (disposable accessories).

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

3.3 Symbols In connection with the UAW handpiece, standardized symbols are used. 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 UAW handpiece can be connected to an ultrasonic generator with or without irrigation. A single foot switch on the ultrasonic generator is used for activating the ultrasonic power. If an ultrasonic generator with irrigation is used, irrigation is activated at the same time.

1

2

3

4

5

Fig. 3.3 UAW handpiece in the entire system 1 2 3

Ultrasonic generator Irrigation tubing (disposable accessory) Instrument cable

4 5

UAW handpiece Single foot switch

3.5

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Transport and storage

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

Storage temperature: between –20 °C and 50 °C (–4 °F and 122 °F).



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



Air pressure: between 700 hPa and 1060 hPa (10.15 psi and 15.37 psi)

4.1

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Operation

5 Operation Only qualified physicians and qualified care staff may treat patients using the UAW handpiece. Any other use of the UAW handpiece in accordance with the intended use is only permitted for qualified specialists. The treating physician or the care staff must weigh the risks of treatment against the benefits. Prior to the first treatment – and prior to any further treatment – the UAW handpiece and the instrument cable must be cleaned, disinfected and sterilized (see chapter ”Reprocessing” on page 22). 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 UAW handpiece to the ultrasonic generator. Functional testing must always be carried out on the ultrasonic generator with the UAW handpiece prior to treatment (see section ”Functional testing” on page 17). Please also observe the instructions for use supplied with the ultrasonic generator when carrying out this test. Aerosols are formed by the irrigation solutions used during wound debridement and during wound cleansing. These aerosols may contain infectious bacteria (bioaerosols). The bioaerosols could spread to the entire treatment room. To prevent infection, the physician and the care staff should wear suitable protective clothing. Fluid-proof protective clothing, safety glasses and a mask covering the mouth and nose are suitable. For suspected blood-borne viruses or existing infections, a class FFP2 mask should be worn. After the treatment the irrigation tubing must be properly disposed of. The UAW handpiece and the instrument cable must be reprocessed (see chapter ”Reprocessing” on page 22).

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Operation Preparing for treatment

5.1 Preparing for treatment First the UAW 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.

5.1.1 Connecting the UAW handpiece to the ultrasonic generator Requirements 

The UAW handpiece is sterile.



The instrument cable is sterile.



An irrigation bottle and a sterile irrigation 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.

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 malfunctions of the UAW handpiece and of the ultrasonic generator. Treatment must be carried out with a redundant system, thereby lengthening the treatment duration. 

Make sure that the contacts on the connector sockets and on the plug connectors are dry before connecting.



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

2. 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 3. Insert the instrument cable into the connector socket on the UAW handpiece. Observe the markings.

– The instrument cable engages in the connector socket. – The OK indicator light on the ultrasonic generator lights. 4. Connect the irrigation tubing with the luer lock port of the UAW handpiece. Hand tighten only. Observe the instructions for use of the ultrasonic generator for using the irrigation bottle and the irrigation tubing.

– The UAW 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 UAW handpiece prior to treatment. The irrigation function and the ultrasonic function are checked during the functional testing. Finally, the power settings on the ultrasonic generator must be checked and adjusted. The ultrasonic power and the irrigation capacity must be ensured. Requirements 

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



The UAW handpiece is connected to the ultrasonic generator.



The OK indicator light on the ultrasonic generator lights.

Procedure 1. For an ultrasonic generator with irrigation: Press and hold the button for filling with irrigation solution until irrigation solution emerges at the sonotrode of the UAW handpiece and there is no more air trapped in the irrigation tubing. For an ultrasonic generator without irrigation: Fill the irrigation tubing until irrigation solution emerges at the sonotrode of the UAW handpiece and there is no more air trapped in the irrigation tubing. 2. Ensure that the connections between the irrigation tubing and the UAW handpiece and between the irrigation tubing and the irrigation bottle do not leak. 3. Activate the UAW handpiece with the foot switch and hold the sonotrode in the air. – Hissing at the sonotrode tip is a sign that ultrasonic power is supplied. 4. Release the foot switch. – Functional testing has been carried out. 5. Check and adjust the irrigation capacity on the ultrasonic generator. 6. Check and adjust the ultrasonic power 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 activating the ultrasonic power. If an ultrasonic generator with irrigation is used, irrigation is activated at the same time. UAW handpieces are available with different sonotrodes. The sonotrode tip may have a double-ball, hoof or spatula form. Select the suitable UAW handpiece. It is crucial for the treatment result that the power settings are correct, in particular for the ultrasonic power. The treatment effect is controlled primarily with the ultrasonic power. The higher the ultrasonic power is set, the stronger the treatment 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 treatment effect to be achieved with the UAW handpiece, irrigation solution must be used. Begin the treatment with a little irrigation solution. In most cases, the preset irrigation capacity with a quantity of 6 ml/min is sufficient. During the treatment, continuously check that solution is directed to the sonotrode tip so the sonotrode tip does not clog or heat. 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 UAW 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 irrigation tubing during the treatment. The staff must not be impeded. They could fall and patients be injured by the sudden movement from the fall.

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

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

Only use a sterile UAW handpiece.



Only use a sterile instrument cable.



Only use sterile irrigation tubing from undamaged packaging.

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Operation Starting treatment

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 UAW handpiece.



Do not use any explosive or flammable materials in the immediate vicinity of the UAW handpiece.

Incorrectly deposited UAW handpiece A UAW handpiece that is not in use can be accidentally activated. A UAW handpiece set down on a patient may result in severe injury to the patient. 

Always set an unused UAW handpiece down on a utility table.



Never set an unused UAW handpiece down on a patient.

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

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

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Operation Ending treatment

5.3 Ending treatment After treatment the UAW handpiece must be disconnected from the ultrasonic generator and disassembled into its constituent parts. The irrigation tubing must be disposed of immediately. The UAW handpiece and the instrument cable must then be reprocessed (see chapter ”Reprocessing” on page 22). All surfaces in the treatment room should also be disinfected.

5.3.1 Disconnecting the UAW handpiece from the ultrasonic generator Requirements 

The ultrasonic generator is switched off.

Procedure 1. Disconnect the instrument cable from the UAW handpiece. To do this, only pull on the grip sleeve of the instrument cable.

2. Disconnect the instrument cable from the ultrasonic generator. To do this, only pull on the grip sleeve of the instrument cable. 3. Disconnect the irrigation tubing from the luer lock port of the UAW handpiece.

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Operation Ending treatment 4. Disconnect the irrigation tubing from the ultrasonic generator and dispose of it properly. – The UAW handpiece has been disconnected from the ultrasonic generator.

If the UAW handpiece cannot be disassembled and reprocessed immediately, place it in a closed jar. The jar protects the UAW handpiece during transport and prevents contamination of the environment. Do not allow any secretions or tissue residues to dry on the instrument. You can completely immerse the UAW handpiece in a cleaning or disinfectant solution. Please observe the information of the manufacturer regarding the temperatures, contact times and concentrations of the cleaning and disinfecting solution.

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