Söring SONOCA 185 User manual

0123
Instructions for use
Ultrasonic Generator
SONOCA 185
Valid from serial number: 94090101
DocNr.: 03-4655 R03.01 | 22.09.2015 | en-US
Ultrasonic Genera tor
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Table of contents
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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 Overview of the ultrasonic generator ...........................................10
3.1.1 Pictograms on the ultrasonic generator .......................................................12
3.1.2 Serial plate................................................................................................................13
3.1.3 Buttons and indicator lights..............................................................................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 Connecting instruments.................................................................22
5.4.1 Connecting the instrument cable to the instrument...............................22
5.4.2 Connecting the irrigation tubing to the instrument ................................23
5.5 Connecting irrigation .....................................................................24
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Table of contents
4Ultrasonic Generator | DocNr.: 03-4655 R03.01 | 22.09.2015 | en-US
6 Operation ......................................................................................................28
6.1 Preparing for treatment .................................................................28
6.1.1 Adjusting the volume.......................................................................................... 28
6.1.2 Functional testing................................................................................................. 29
6.2 Starting treatment ..........................................................................30
6.3 Ending treatment............................................................................32
6.3.1 Turning off the ultrasonic generator ............................................................. 32
6.3.2 Disconnecting the instrument from the ultrasonic generator............. 32
6.3.3 Detaching the irrigation bottle........................................................................ 33
6.3.4 Disconnecting the foot switch......................................................................... 33
6.3.5 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 Faults................................................................................................37
8.1.1 Faults occurring during the self-test.............................................................. 37
8.1.2 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
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Information about these instructions for use
1Introduction
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 ul-
trasonic 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 instruc-
tions 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 cat-
egorized into hazard levels with consequences of differing severity.
All warning information is structured according to the same model. The type of haz-
ard 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.
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.
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Introduction
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General conditions
1.3 General conditions
Ensure that the following conditions are met when working with the ultrasonic gen-
erator:
These instructions for use must be read prior to using the ultrasonic generator.
Prior to connecting an instrument to the ultrasonic generator, read the instruc-
tions for use for the instrument.
Report any recurring faults or problems to Söring GmbH or an authorized distrib-
utor.
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
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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 con-
nected 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 ultra-
sonic 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 op-
erator (and trained by either the manufacturer or an authorized distributor) must pro-
vide instruction in handling the ultrasonic generator with the help of this user
manual.
Only qualified and trained physicians may operate on patients using instruments con-
nected to the ultrasonic generator. Only UAW handpieces may also be used by quali-
fied 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 suffi-
cient experience.
Access to the ultrasonic generator is not permitted to insufficiently qualified person-
nel.
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Safety
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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 electro-
magnetic 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
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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 gen-
erator.
2.8 High frequency current
No high-frequency current may flow through connected instruments.
2.9
Warning sticker Meaning
Read the instructions for use
High voltage warning
Hazardous area warning
Risk of entanglement warning
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Overview
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Overview of the ultrasonic generator
3Overview
3.1 Overview of the ultrasonic generator
Fig. 3.1 Front
1 Operator control panel for ultrasonic power
2 Operator control panel for irrigation
3 Display panel
4 Irrigation pump
5 Connector socket for an instrument
6 Connector socket for a foot switch
7 Power switch
5
764
123
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Overview
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Overview of the ultrasonic generator
Fig. 3.2 Back
Fig. 3.3 Left
1 Connector socket for the power cord
2Loudspeaker
3Serialplate
4Volumecontrol
5 Connection for the potential equalization
cable
6 Fuse holder
1 Irrigation pump
- Lautstärke +
- Volume +
Netzanschluß
Power Cord
Tx.xAH
Funk / Radio
Versorgungs-
spannung
Supply
Voltage
Söring GmbH
Justus-von-Liebig-Ring 2
D-25451 Quickborn
Germany
Typ / Model:
Ausgangsdaten / Output data
20XX SN XXXXXXX
Sonoca XXX
XXXXXXX
Made in
Germany
0123
Spannung / Voltage:
Strom / Current:
Sicherung / Fuse:
Leistungsaufnahme / Power consumption:
Einschaltdauer / switch on duration:
XXX W
-
-
Leistung
Power
Frequenz
Frequency
20-80 Hz
-
-
-
-
-
-
XXX V 50/60 Hz
X.X A max
TX.XAH
XXX VA
100 %
6
5
4
1 2 3
1
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Overview
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Overview of the 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
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Overview of the ultrasonic generator
3.1.2 Serial plate
The serial plate is attached to the back of the ultrasonic generator.
Fig. 3.4 Serial plate
1 Manufacturer
2Type
3 Serial number
4 Output voltage
5 Maximum current consumption
6 Power fuse
7 Maximum power consumption
8 Maximum activation time
9 Frequency
10 Maximum output power
11 Year of manufacture
Söring GmbH
Justus-von-Liebig-Ring 2
D-25451 Quickborn
Germany
Ausgangsdaten / Output data
SN
Made in
Germany
0123
-
-
-
-
-
-
-
-
Spannung / Voltage:
Stromaufnahme / Current consumption: max.
Sicherung / Fuse:
Leistungsaufnahme / Power consumption: max.
Einschaltzyklus / duty cycle
Leistung / Power
max.
Frequenz
Frequency
Typ / Model:
Art. #.:
4
5
6
7
8
9
10
2
311
1
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Overview
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Overview of the ultrasonic generator
3.1.3 Buttons and indicator lights
Operator control panel for ultrasonic power
Ultrasonic power can be increased and decreased on the operator control panel for
ultrasonic power. Alternatively, the ultrasonic power can be selected directly. Ultra-
sonic power can still be adjusted afterwards. The selected ultrasonic power is dis-
played. An indicator light goes on as soon as an instrument becomes active.
Fig. 3.5 Operator control panel for ultrasonic power
Operator control panel for irrigation
Irrigation flow can be increased and decreased on the operator control panel for irriga-
tion. 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.
Fig. 3.6 Operator control panel for irrigation
1 Display for ultrasonic power
2 Button for increasing ultrasonic power
3 Button for decreasing ultrasonic power
4 Buttons for direct selection of the ultrasonic
power
5 Indicator light for instrument activity
1
2
5
4
3
1 Button for increasing the irrigation flow
2 Button for filling the irrigation tube
3 Button for reducing the irrigation flow
4 Indicator light for the irrigation flow
1
2
3
4
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Overview
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Overview of the ultrasonic generator
Display panel
The display panel provides information about the status of the ultrasonic generator
and instrument activation time.
The digital display shows the activation time (in minutes) of the connected instru-
ment 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 light goes on.
Fig. 3.7 Display panel
1TheERROR indicator light goes on if a safety shut-down or a fault has occurred
2 Digital display
3TheOK indicator light goes on when the ultrasonic generator is ready for use
2
3 1
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Overview
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Scope of delivery
3.2 Scope of delivery
The ultrasonic generator comes without accessories.
Performing a treatment requires an instrument and other accessories. Ultrasonic gen-
erator 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
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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 in-
strument 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.
Fig. 3.8 Use of an instrument (Example: UAW handpiece)
3.4
1 Ultrasonic generator
2 Irrigation bottle
3 Irrigation tubing
4 Instrument cable
5 Instrument with irrigation
6 Single foot switch
12
4
3
5
6
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Transport and storage
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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 quali-
fied person authorized by the manufacturer.
4.1
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Installation
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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 sup-
ply.
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
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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 ultra-
sonic generator if required.
4. If necessary, connect the potential equalization cable to the potential equaliza-
tion 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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