SONOCA 300 User Manual July 2012

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Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Table of Contents

Table of Contents

1 Introduction ... 5 1.1

Information About This User Manual ... 5

1.2 1.2.1 1.2.2

Display Conventions... 5 Safety Information and Warnings... 5 Additional Information... 6

1.3

General Conditions ... 6

2 Safety ... 7 2.1

Intended Use ... 7

2.2

General Safety Information... 7

3 Overview...10 3.1 3.1.1 3.1.2 3.1.3

Overview of the Ultrasonic Generator ...10 Symbols on the ultrasonic generator...13 Type plate...14 Operator control panels...14

3.2

Scope of delivery...17

3.3

System overview ...17

4 Transport and storage...19 5 Installation ...20 5.1

Connecting the ultrasonic generator to the supply network...20

5.2 5.2.1 5.2.2 5.2.3

Putting the ultrasonic generator into operation ...21 Preparing the ultrasonic generator ...21 Connecting the instrument ...25 Turning on the ultrasonic generator...25

6 Operation ...27 6.1

Checking the settings ...27

6.2 6.2.1 6.2.2 6.2.3

Beginning treatment ...29 Using an instrument with rinsing and suction ...30 Using an instrument with rinsing ...31 Using an instrument without rinsing and suction...31

6.3

Ending treatment...32

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Table of Contents

7 Reprocessing ...34 7.1

Cleaning the ultrasonic generator and accessories ...34

7.2

Disinfecting the ultrasonic generator and accessories...35

7.3

Sterilising the accessories ...35

8 Maintenance...36 8.1

Regular checks ...36

8.2

Faults...36

8.3

Repairs ...38

9 Disposal ...39 10 Technical Data...40 Index ...41

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Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Introduction

1 Introduction 1.1 Information About This User Manual This user manual is intended to help you use the ultrasonic generator optimally. In particular, the installation, start-up and safe operation of the ultrasonic generator are described. The medical application is not described. This user manual is included with the ultrasonic generator. Please read the user manual completely before using the ultrasonic generator. Please keep this manual for future reference. The ultrasonic generator is intended for use with other instruments and accessories from Söring. Please also observe the instructions for use supplied with the instruments. If you have further questions on the content of this user manual or use of the ultrasonic generator, please contact Söring GmbH (contact data on back page) or an authorised dealer.

1.2 Display Conventions 1.2.1 Safety Information and Warnings In this user manual safety information and warnings are marked by symbols and signal words. Hazards are categorised into four levels.

Names the source of the hazard Describes the results of the hazard. This will result in death or severe personal injury. 

Specifies the steps that must be taken to eliminate the hazard.

Names the source of the hazard Describes the results of the hazard. This could result in death or severe personal injury. 

Specifies the steps that must be taken to eliminate the hazard.

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Introduction

Names the source of the hazard Describes the results of the hazard. This could result in minor personal injury. 

Specifies the steps that must be taken to eliminate the hazard.

Names the source of the hazard Describes the results of the hazard. This could result in material damage. 

Specifies the steps that must be taken to eliminate the hazard.

1.2.2 Additional Information In this user manual special information is marked by the following symbol.

Gives further information about the ultrasonic generator.

1.3 General Conditions Take the following conditions into account when using the ultrasonic generator: 

The user manual must be read before the ultrasonic generator can be used.



Before connecting an instrument to the ultrasonic generator, you must have read the user manual of the instrument.



Any recurring faults or problems must be reported to Söring GmbH or an authorised dealer.

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

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

Modifications of the ultrasonic generator,



improper use,



use of non-recommended instruments,



use of accessories other than the recommended ones,



improper handling,



non-compliance with this user manual.

Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Safety

2 Safety 2.1 Intended Use The ultrasonic generator is solely intended for use in ultrasonic surgery and wound treatment on humans. The precise application is determined by the instrument connected. Only the instruments and the accessories which are specified in the system overview can be connected (see chapter 3.3 System overview on page 17). This results in applications for 

the selective dissection of tissue,



the cutting of tissue,



the coagulation of tissue.

The ultrasonic generator may only be used in medical operating rooms. Only surgeons may operate on patients with instruments which are connected to the ultrasonic generator. The ultrasonic generator may only be used by qualified specialists including OP staff, physicians, sterilisation department staff, medical technicians and medical technical assistants. The ultrasonic generator is only intended for use with instruments from Söring. Any other use is considered to be improper use. The local health and safety at work, hygiene and safety regulations and the specifications in this user manual and the user manual of the instrument used must be complied with.

2.2 General Safety Information

Insufficient qualification Improper use of the ultrasonic generator can lead to severe personal injury, irreversible physical injury or death. 

Only deploy qualified specialists.



Do not grant access to unauthorised persons.



Contact the manufacturer if necessary for repairs and maintenance work.

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Safety

Magnetic fields Magnetic fields can affect the ultrasonic generator function and severely injure patients. 

Do not use the ultrasonic generator in the area of influence of magnetic fields.



Ensure electromagnetic compatibility.

Damaged cable Electric shock due to damaged mains cable insulation can lead to severe personal injury or death. 

Check the cable for damage.



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



Replace the cable if damaged.



Only use undamaged cables.

Improperly connected instrument cable An improperly connected instrument cable can lead to malfunctioning of the ultrasonic generator and severely injure patients.

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

Correctly connect the instrument cable.



Prior to each use of an instrument, ensure that the instrument cable is properly connected.

Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Safety

Damaged or improperly connected suction hose The working area and the instruments can be contaminated due to a damaged or improperly connected suction hose. This can result in life-threatening injury to persons. 

Connect the suction hose correctly.



Check the suction hose for damage.



Only use an undamaged suction hose.

Wrong instruments Use of instruments that are not specified can lead to malfunctions and severely injure patients. 

Only use specified instruments (see chapter 3.3 System overview on page 17).

Incorrect accessories Use of accessories other than those recommended can lead to malfunctions and severely injure patients. 

Only use recommended accessories (see catalogues).

Use with other medical devices Use of the ultrasonic generator in combination with medical devices from other manufacturers can have incalculable consequences. 

Only use the ultrasonic generator in combination with suitable medical devices (e.g. a suitable suction container). The user bears the responsibility for use with any other medical devices.

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Overview

3 Overview 3.1 Overview of the Ultrasonic Generator The ultrasonic generator can be operated at three working frequencies (25 kHz, 35 kHz and 55 kHz) so that different treatments can be carried out. Both ultrasonic instruments for selective tissue separation and for wound treatment as well as ultrasonic scissors and ultrasonic hooks for cutting and coagulating as well as bone instruments for preparing bone tissue can be operated with the ultrasonic generator. The function of the ultrasonic generator is process-controlled. Automatic instrument detection ensures preselection of performance parameters. The performance parameters can be adjusted on the operator control panels to the requirements of the treatment. The working frequencies are determined by the instrument used; they cannot be altered. A rinsing and suction device is also integrated in the ultrasonic generator. The tissue is suctioned off and collected in a suction container. The ultrasonic treatment is triggered with a foot switch. At the same time – depending on the instrument connected – the rinsing and suction are activated.

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Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Overview

5 6 1

2

3

Absaugung Aspiration - 0,9 bar

4

Spülung Irrigation

Ultraschall Ultrasound

100 %

150 ml

100 %

Information Schlauch befüllen

Pump on/off

Filling hose

0

%

20

1

40 40

2

60 60

3

80 80

100 100

Aspiration (vac)

bar

Frequency

kHz

Irrigation

ml/min

Active time

min

4 OK

0

0

7

ERROR

0

GmbH

0

11

10

9

8

Fig. 3.1 Front side 1 2 3 4 5 6

Operator control panel for suction Operator control panel for the ultrasonic treatment Operator control panel for the rinsing Operator control panel for the settings Boom for a rinsing bottle Rinsing bottle (not part of the scope of delivery)

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Suction container (not part of the scope of delivery) 8 Hose pump for rinsing fluid 9 Connector socket for an instrument 10 Connector socket for a foot switch 11 Mains switch

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Overview

1

2

3

4

Söring GmbH Justus-von-Liebig-Ring 2 D-25451 Quickborn Germany

Vacuum

T2.0AH

Emergency Vacuum

Made in Germany

0123

10

Typ / Model:

Sonoca XXX XXXXXXX

20XX

Netzanschluß Power Cord

XXX XXX V V 50/60 50/60 Hz Hz

Strom Strom // Current: Current:

X.X X.X A A max max

Sicherung Sicherung // Fuse: Fuse:

TX.XAH TX.XAH

Leistungsaufnahme Leistungsaufnahme // Power Power consumption: consumption: Einschaltdauer Einschaltdauer // switch switch on on duration: duration:

XXX XXX VA VA 100 100 % %

Ausgangsdaten / Output data Leistung Leistung Power Power

--

9

8

Emergency Pumpswitch

SN XXXXXXX

Spannung Spannung // Voltage: Voltage:

Frequenz Frequenz Frequency Frequency

--

XXX XXX W W

20-80 20-80 Hz kHz

--

--

--

--

--

--

7

- Lautstärke + - Volume +

6

5

Fig. 3.2 Rear side 1 2 3 4 5

Connector socket for the mains cable Connector socket for the vacuum hose Type plate Switch for the emergency pump (not part of the scope of delivery) Loudspeaker

1

6 7 8 9

Volume regulator Holder for the bacteria filter Bacteria filter Connection for the potential equalisation cable 10 Fuse holder

2

3

Fig. 3.3 Left side 1 2 3

12

Hose pump Holder for the suction container Holding pipe for the boom

Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Overview

3.1.1 Symbols on the ultrasonic generator Symbol

Meaning Read user manual Type BF Instrument active Instrument Foot switch High voltage Potential equalisation Non-ionising radiation Hazardous waste

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Overview

3.1.2 Type plate The type plate is attached on the back of the ultrasonic generator.

Made in Germany

0123

Söring GmbH Justus-von-Liebig-Ring 2 D-25451 Quickborn Germany

Typ / Model: 20XX

1

Sonoca XXX XXXXXXX

3

2 4

SN XXXXXXX

Spannung / Voltage:

6

Strom / Current: Sicherung / Fuse: Leistungsaufnahme / Power consumption:

8

Einschaltdauer / switch on duration:

5

XXX V 50/60 Hz X.X A max

7

TX.XAH XXX VA

9

100 %

Ausgangsdaten / Output data Leistung Power

-

Frequenz Frequency

10 20-80 kHz 11

-

XXX W

-

-

-

-

-

-

Fig. 3.4 Type plate 1 2 3 4 5 6

Manufacturer Type Year of construction Serial number Voltage Current

7 Fuse 8 Power consumption 9 Duty cycle 10 Power output 11 Frequency

3.1.3 Operator control panels Operator control panel for suction The suction capacity can be increased and reduced on the operator control panel for the suction. The selected suction capacity is displayed. The suction pump can be switched on and off.

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Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Overview

Absaugung Aspiration - 0,9 bar

1

100 %

4 2

Pump on/off

3 0

0

Fig. 3.5 Operator control panel for the suction 1 2

Button for increasing the suction capacity Button for switching the suction pump on and off

3 4

Button for reducing the suction capacity Display of the suction capacity

Operator control panel for the ultrasonic treatment The ultrasonic power can be increased and reduced on the operator control panel for ultrasonic treatment. Alternatively, four preset ultrasonic power values can be selected. The selected ultrasonic power is displayed. A display lights as soon as an instrument is active. Ultraschall Ultrasound

5

1 4

0

%

20

1

40

2

60

3

100

80

4

2

3 Fig. 3.6 Operator control panel for the ultrasonic treatment 1 2 3

Display of the ultrasonic power Button for increasing the ultrasonic power Button for reducing the ultrasonic power

4 5

Buttons for selecting four preset ultrasonic power values Display of the instrument activity

Operator control panel for the rinsing The rinsing capacity can be increased and reduced on the operator control panel for the rinsing. The selected rinsing capacity is displayed. The rinsing hose can also be filled.

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Overview

Spülung Irrigation 150ml

1

100 %

4 2 Schlauch befüllen Filling hose

3 0

0

Fig. 3.7 Operator control panel for the rinsing 1 2

Button for increasing the rinsing capacity Button for activating the hose filling

3 4

Button for reducing the rinsing capacity Display for the rinsing capacity

Operator control panel for the settings Settings information can be called up at the touch of a button on the operator control panel for the settings. Information is displayed of the following: 

The suction pressure [bar],



the working frequency of the instrument used [kHz],



the volume of rinsing fluid fed in [ml/min],



the activation duration of the instrument [min].

In the event of a malfunction, a numerical code is displayed and the ERROR display lights. If the ultrasonic generator is ready for use, the OK display lights.

5 4

Aspiration (vac)

1

bar

Frequency

kHz

Irrigation

ml/min

Active time

min

2 OK

ERROR

3 Fig. 3.8 Operator control panel for the settings 1 2 3

16

Display for the information ERROR display that lights upon a safety shutdown or an internal fault OK display that lights if the ultrasonic generator is ready for use

4 5

Button for calling up information Type of information called up

Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Overview

3.2 Scope of delivery The ultrasonic generator is delivered without further accessories. Recommended accessories are listed in the catalogs. Only use recommended accessories. For the latest information regarding accessories, please visit our website at www.soering.com

3.3 System overview Use with a micro ENP handpiece or a micro suction pen handpiece Micro-ENP Micro Suction Pen 92-XXX

Suction hose Rinsing hose 700S0016

Suction container

Vacuum hose 300K0011 300K0013

Sonoca 300

Suction hose Rinsing hose 700S0016

Suction container

Vacuum hose 300K0011 300K0013

Sonoca 300

Rinsing hose 700S0010 700S0310

Sonoca 300

Rinsing hose 700S0009 700S0010 700S0309 700S0310

Sonoca 300

Instrument cable 240K0095 240K0195

Use with a macro handpiece Macro 94-XXX Instrument cable 240K0094 240K0194

Use with a micro pen handpiece Micro Pen 91-XXX

Instrument cable 240K0095 240K0195

Use with a UAW handpiece UAW 97-XXX

Instrument cable 240K0094 240K0194

Use with a ultrasonic hook Hooks 96-XXX

Instrument cable 240K0094 240K0194

Sonoca 300

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Overview

Use with ultrasonic scissors Scissors 96-XXX

98-XXX

Instrument cable 240K0094 240K0194

Sonoca 300

Instrument cable 240K0095 240K0195

Use with a bone instrument Bone 92-05X

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Instrument cable 240K0095 240K0195

Rinsing hose 700S0010 700S0310

Sonoca 300

Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en

Transport and storage

4 Transport and storage The ultrasonic generator is supplied in packaging which protects it against damage and contamination. Keep this packaging. Use the packaging if you want to transport the ultrasound generator again or put it in storage. The storage environment must be dry, clean and dust-free. 

Storage temperature between –20 °C and 50 °C.



Relative humidity: Maximum 85 %.

After any transport or after lengthy storage, the safety of the ultrasonic generator must be checked (see chapter 8.1 Regular checks on page 36).

DocNr.: 03-1211_R02.01 | 07-2012 | en | Sonoca 300

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Installation

5 Installation The ultrasonic generator must only be put into operation by competent persons who are authorised by the manufacturer. The ultrasonic generator must be installed on a suitable surface which is sufficiently load-bearing and easily accessible.

5.1 Connecting the ultrasonic generator to the supply network The following accessories are required for connecting the ultrasonic generator to the supply network: 

a mains cable,



a potential equalisation cable.

Supply network without protective earth Electric shock due to a missing protective earth in the supply network can lead to severe personal injury or death. 

Only connect the ultrasonic generator to a supply network with protective earth.

Damages mains cable Electric shock due to damaged mains cable insulation can lead to severe personal injury or death. 

Check the mains cable for damage.



Replace the damaged mains cable.



Only use an undamaged mains cable.

Requirements 

The actual mains voltage corresponds to the voltage shown on the type plate.



The ultrasonic generator is switched off; the mains switch is set to 0.

Procedure 1. Insert the mains cable in the connector socket on the back of the ultrasonic generator (see Fig. 3.2 on page 12, position 1). 2. Connect the mains cable to the supply network.

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Sonoca 300 | DocNr.: 03-1211_R02.01 | 07-2012 | en