Soring
SONOCA 185 Instructions for Use Sept 2015
Instructions for Use
50 Pages
Preview
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Instructions for use
Ultrasonic Generator SONOCA 185 Valid from serial number: 94090101
DocNr.: 03-1241_R05.01 | 30.09.2015 | en-US Ultrasonic generator
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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
Selection and qualification of specialist staff... 7
2.3
Operating environment ... 8
2.4
Length of treatment ... 8
2.5
Cable and accessory management ... 8
2.6
At risk patients ... 9
2.7
Prohibition and warning signs... 9
2.8
High frequency current ... 9
3 Overview...10 3.1 3.1.1 3.1.2 3.1.3
Overview of ultrasonic generator...10 Pictograms on the ultrasonic generator ...12 Serial plate...13 Buttons and indicator lamps ...14
3.2
Scope of delivery...16
3.3
System overview ...17
4 Transport and storage...18 5 Installation ...19 5.1
Connecting the ultrasonic generator to the main power supply 19
5.2
Connecting the foot switch ...20
5.3
Turning on the ultrasonic generator ...21
5.4 5.4.1 5.4.2
Connecting instruments...22 Connecting the instrument cable to the instrument ...22 Connecting the irrigation tubing to the instrument ...23
5.5
Connecting irrigation ...24
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Table of contents
6 Operation ...28 6.1 6.1.1 6.1.2
Preparing for treatment ...28 Adjusting the volume... 28 Functional testing... 29
6.2
Starting treatment ...30
6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5
Ending treatment...32 Turning off the ultrasonic generator ... 32 Disconnecting the instrument from the ultrasonic generator... 32 Detaching the irrigation bottle... 33 Disconnecting the foot switch ... 33 Disconnecting the ultrasonic generator from the main power supply ... 34
7 Reprocessing ...35 7.1
Cleaning the ultrasonic generator and accessories ...36
7.2
Disinfecting the ultrasonic generator and accessories...36
8 Preventive maintenance ...37 8.1 8.1.1 8.1.2
Faults...37 Faults occurring during the self-test... 37 Faults occurring during operation... 38
8.2
Safety check...39
8.3
Repairs ...39
9 Disposal ...40 10 Technical data ...41 11 Electromagnetic compatibility ...42 Index ...45
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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 assist you in properly using the ultrasonic generator. Emphasis is placed on the installation, start-up and safe operation of the ultrasonic generator. Medical application is not described. The basic principles of ultrasonic surgery can be found in the medical literature. These instructions for use come with the ultrasonic generator. Read the instructions for use thoroughly before using the ultrasonic generator. Please keep these instructions for use for future reference. The ultrasonic generator is intended for use with instruments and accessories from Söring. Please also refer to the instructions for use of the instruments and accessories used. If you have any questions about the content of these instructions for use or the use of the ultrasonic generator, contact Söring GmbH (contact details on back cover) 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 have a serious impact on health. The could result in death or have a serious impact on health. This may have a serious impact on health. This could result in material damage.
All warning information is structured according to the same model. The type of hazard is stated after the signal word. Then the consequences that may result from the hazardous situation are described. And finally, how the hazardous situation can be avoided.
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Introduction General conditions
1.3 General conditions Ensure that the following conditions are met when working with the ultrasonic generator:
These instructions for use must be read prior to using the ultrasonic generator.
Prior to connecting an instrument to the ultrasonic generator, read the instructions for use for the instrument.
Report any recurring faults or problems to Söring GmbH or an authorized distributor.
Söring GmbH does not accept liability for any damage or personal injury arising from:
Modifications or manipulation of the ultrasonic generator
Improper use
Use of non-approved instruments
Use of non-approved accessories
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 ultrasonic generator is intended solely for use in ultrasonic surgery on humans. In doing so, the ultrasonic generator temporarily transfers and controls energy to a connected instrument. It also provides an irrigation function. Only Söring instruments may be connected to the ultrasonic generator. The use of other instruments is not permitted. The precise medical purpose is determined by the instrument connected. The ultrasonic generator is suitable for the following applications:
Mechanical removal and cutting of bones
Wound debridement and wound cleansing
Removal of fibrin tissue and breaking up biofilms
It is not intended for use directly on the eyes or the central circulatory system. Any use other than that specified is considered to be improper use.
2.2 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 this user manual. Only qualified and trained physicians may operate on patients using instruments connected to the ultrasonic generator. Only UAW handpieces may also be used by qualified nursing staff to perform wound debridement or wound cleansing. Any other intended use – e.g. for operation and reprocessing – is only permitted for qualified specialists such as operating room personnel and sterilization department personnel possessing the required education, training or knowledge as well as sufficient experience. Access to the ultrasonic generator is not permitted to insufficiently qualified personnel.
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Safety Operating environment
2.3 Operating environment The ultrasonic generator may only be used in inpatient and outpatient medical rooms. In close vicinity to the instrument, the atmosphere must not be oxygen enriched nor may there be any 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 magnetic resonance imaging, can influence the function of the ultrasonic generator. For this reason, ensure electromagnetic compatibility of other electrical devices. Use only medical electrical devices that meet the requirements of IEC 60601-1-2 for electromagnetic compatibility. The specified ambient temperature, relative humidity and air pressure conditions must be maintained at all times.
2.4 Length of treatment Under normal conditions, the ultrasonic generator is intended for use of no longer than 60 minutes in total. Some of the instruments however may not be activated as long. During a treatment you should therefore follow the maximum procedure time specified for each instrument.
2.5 Cable and accessory management Make sure that the cables and accessories are in perfect condition. Damaged insulation on the power cord or instrument cable may result in electric shock and cause serious injury or death.
Check every cable for damage.
If a cable is damaged, immediately turn off the power (or keep it turned off).
Replace every damaged cable.
Use of unauthorized accessories may lead to malfunction and cause severe injury to patients as well as operators. Use only approved accessories (see catalog or our website: www.soering.com).
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Safety At risk patients
2.6 At risk patients The treatment of at risk patients can lead to death or have a serious impact on health. At risk patients may include pregnant women, hemophiliacs as well as infants and children up to 13 years of age. Prior to treatment follow the safety instructions for at risk patients in the instrument's instructions for use. In each case, as the treating physician you are responsible for weighing the risks of treatment against the benefits. If you decide on treatment, ensure that all measures for lowering risks have been taken before commencing treatment.
2.7 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
2.8 High frequency current No high-frequency current may flow through connected instruments.
2.9
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Overview Overview of ultrasonic generator
3 Overview 3.1 Overview of ultrasonic generator 1
2
3
7
4
6
5
Fig. 3.1 Front side 1 2 3 4
10
Operator control panel for ultrasonic power Operator control panel for irrigation Display panel Irrigation pump
5 6 7
Connector socket for an instrument Connector socket for a foot switch Power switch
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Overview Overview of ultrasonic generator
1
2
3
6
Made in Germany
0123
Söring GmbH Justus-von-Liebig-Ring 2 D-25451 Quickborn Germany
Tx.xAH
Funk / Radio
Typ / Model:
Sonoca XXX XXXXXXX
20XX
Netzanschluß Power Cord
SN XXXXXXX
Spannung / Voltage:
XXX V 50/60 Hz
Strom / Current:
X.X A max
Sicherung / Fuse:
TX.XAH
Leistungsaufnahme / Power consumption: Einschaltdauer / switch on duration:
XXX VA 100 %
Ausgangsdaten / Output data
Versorgungsspannung Supply Voltage
5
Leistung Power
-
- Lautstärke + - Volume +
Frequenz Frequency
-
XXX W
20-80 Hz
-
-
-
-
-
-
4 Fig. 3.2 Rear side 1 2 3
Connector socket for the power cord Loudspeaker Serial plate
4 5 6
Volume control Connection for the potential equalization cable Fuse holder
1 Fig. 3.3 Left side 1
Irrigation pump
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Overview Overview of ultrasonic generator 3.1.1 Pictograms on the ultrasonic generator Pictogram
Meaning Read the instructions for use Type BF (classification in accordance with EN 60601-1) Instrument Foot switch High voltage High voltage warning Hazardous area warning Risk of entanglement warning Potential equalization Non-ionizing radiation Hazardous waste
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Overview Overview of ultrasonic generator 3.1.2 Serial plate The serial plate is attached to the back of the ultrasonic generator.
Made in Germany
0123
Söring GmbH Justus-von-Liebig-Ring 2 D-25451 Quickborn Germany
11
2
Typ / Model: Art. #.:
3
SN
4 5
Spannung / Voltage: Stromaufnahme / Current consumption:
max.
6
Sicherung / Fuse: Leistungsaufnahme / Power consumption:
max.
Einschaltzyklus / duty cycle
7
Ausgangsdaten / Output data -
1
Leistung / Power max.
Frequenz Frequency
-
-
-
-
-
-
8 9 10
Fig. 3.4 Serial plate 1 2 3 4 5 6
Manufacturer Type Serial number Output voltage Maximum current consumption Power fuse
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7 Maximum power consumption 8 Maximum activation time 9 Frequency 10 Maximum output power 11 Year of manufacture
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Overview Overview of ultrasonic generator 3.1.3 Buttons and indicator lamps Operator control panel for ultrasonic power The ultrasonic power can be increased and decreased on the operator control panel for ultrasonic power. Alternatively, the ultrasonic power can be selected directly. Ultrasonic power can still be adjusted afterwards. The selected ultrasonic power is displayed. An indicator lamp lights up as soon as an instrument becomes active.
5
Ultraschall Ultrasound
1 4
0
20
%
40
1
3
60
3
2
100
80
4
2
Fig. 3.5 Operator control panel for ultrasonic power 1 2 3
Display for ultrasonic power Button for increasing ultrasonic power Button for decreasing ultrasonic power
4 5
Buttons for direct selection of ultrasonic power Display for instrument activity
Operator control panel for irrigation Irrigation flow can be increased and decreased on the operator control panel for irrigation. The selected irrigation flow is shown as a percentage on the operator control panel and in millimeters per second on the display panel (see ”Display panel” on page 15). The irrigation tubing can also be filled. Spülung Irrigation
4
150ml
100 %
1 2
Schlauch befüllen Filling hose
3 0
0
Fig. 3.6 Operator control panel for irrigation 1 2
14
Button for increasing the irrigation flow button for filling the irrigation tube
3 4
Button for reducing the irrigation flow Indicator light for the irrigation flow
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Overview Overview of ultrasonic generator Display panel The display panel provides information about the status of the ultrasonic generator and the instrument procedure time. The digital display shows the procedure time (in minutes) of the connected instrument since the application was started. If a fault is detected during the self-test, a numeric code is displayed and the ERROR indicator light goes on. If a safety shutdown occurs during operation, the ERROR indicator light goes on. If an ultrasonic generator overload occurs, the OK indicator light flashes and in this case the ultrasonic generator automatically reduces ultrasonic power. As soon as the ultrasonic generator is ready for use, the OK indicator lights.
1 3
OK
ERROR
2 Anwendungszeit (min) Treatment time (min)
Fig. 3.7 Display panel 1 2 3
The ERROR indicator light goes on if a safety shut-down or a fault has occurred Digital display The OK indicator light goes on when the ultrasonic generator is ready for use
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Overview Scope of delivery
3.2 Scope of delivery The ultrasonic generator comes without accessories. Performing a treatment requires an instrument and other accessories. Ultrasonic generator accessories include:
A foot switch
A power cord
A potential equalization cable (when using multiple medical electrical devices)
A cart
Only use approved accessories. Approved accessories are listed in the catalog. For the latest information regarding accessories, please visit our website: www.soering.com
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Overview System overview
3.3 System overview The following instruments can be connected to the ultrasonic generator:
Bone instrument 92-050
UAW handpieces 97-102, 97-103, 97-104, 97-112.
These instruments are only activated by a single foot switch. The indicator light for instrument activity goes on. Irrigation is activated at the same time. Irrigation solution is routed through the instrument. When the foot switch is no longer pressed, ultrasonic power is cut and irrigation stops.
1
2
4
3
5 6 Fig. 3.8 Use of an instrument (Example: UAW handpiece) 1 2 3
Ultrasonic generator Irrigation bottle Irrigation tubing
4 5 6
Instrument cable Instrument with irrigation Single foot switch
3.4
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Transport and storage
4 Transport and storage For transport and storage of the ultrasonic generator, use packaging which protects it from damage and contamination. 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 (10.2 psi and 15.3 psi)
After transport, the function of the ultrasonic generator must be checked by a qualified person authorized by the manufacturer.
4.1
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Installation Connecting the ultrasonic generator to the main power supply
5 Installation The ultrasonic generator may only be put into operation by a qualified person who has been trained in the proper handling of it. Improper handling of the ultrasonic generator may lead to life-threatening situations or substantial material damage. The qualified specialists who are the intended users of the ultrasonic generator must be instructed in its proper handling. The ultrasonic generator must be installed on a suitable surface which is adequately load-bearing and accessible. Carts from Söring are recommended.
5.1 Connecting the ultrasonic generator to the main power supply A power cord is required to connect the ultrasonic generator to the main power supply. If multiple medical electrical devices are being used in the patient's surroundings a 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.
Main power supply with no grounding conductor An electric shock resulting from the lack of a grounding conductor in the main power supply may cause serious injury or death.
Only connect the ultrasonic generator to a main power supply with grounding conductor.
Damaged power cord Damaged insulation on the power cord may result in electric shock and cause serious injury or death.
Check the power cord for damage.
Replace the power cord if damaged.
Use only an undamaged power cord.
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Installation Connecting the foot switch Requirements
The actual power voltage corresponds to the output voltage shown on the serial plate.
The ultrasonic generator is turned off; the power switch is set to '0'.
Procedure 1. Connect the power cord to the connector socket on the back of the ultrasonic generator. 2. Connect the power cord to the main power supply. 3. Connect a potential equalization cable to the connection on the back of the ultrasonic generator if required. 4. If necessary, connect the potential equalization cable to the potential equalization rail in the room. – The ultrasonic generator is connected to the main power supply.
5.2 Connecting the foot switch A single foot switch must be connected to the ultrasonic generator. Procedure 1. Connect the cable on the foot switch to the connector socket on the front of the ultrasonic generator. – The foot switch cable engages in the connector socket. – The foot switch is connected.
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