Söring SONOCA 185 User Manual Manual

Ultrasonic Generator SONOCA 185 Valid from serial number: 94090101 DocNr.: 03-4655 R03.01 | 22.09.2015 | en-US Ultrasonic Generator

DocNr.: 03-4655 R03.01 | 22.09.2015 | en-US | Ultrasonic Generator 3 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

4 Ultrasonic 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

5 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 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.

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

7 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.

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).

9 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

Overview of the ultrasonic generator 3 Overview 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 7 6 4 1 2 3

11 Overview of the ultrasonic generator Fig. 3.2 Back Fig. 3.3 Left 1 Connector socket for the power cord 2 Loudspeaker 3 Serial plate 4 Volume control 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

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

13 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 2 Type 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 3 11 1

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

15 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 1 The ERROR indicator light goes on if a safety shut-down or a fault has occurred 2 Digital display 3 The OK indicator light goes on when the ultrasonic generator is ready for use 2 3 1

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

17 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 1 2 4 3 5 6

18 Ultrasonic Generator | DocNr.: 03-4655 R03.01 | 22.09.2015 | en-US 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

19 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.

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.

21 Turning on the ultrasonic generator 5.3 Turning on the ultrasonic generator Refer to the instructions for use of the instrument and the accessory before starting the ultrasonic generator. After being turned on, the ultrasonic generator runs through a self-test. During the self-test, check that all indicator lights go on briefly. Faulty initial start-up Faulty initial start-up of the ultrasonic generator may result in life-threatening situa- tions or cause significant material damage.  The ultrasonic generator may only be put into operation for the first time by per- sonnel authorized to do so by the manufacturer. Requirements  The ultrasonic generator is connected to the main power supply.  A foot switch is connected.  The ultrasonic generator has reached the permissible temperature for use (be- tween 10 °C and 40 °C (50 °F and 104 °F)). Procedure 1. Turn the volume control on the back of the ultrasonic generator all the way to the right. 2. Turn on the ultrasonic generator using the power switch. – The green power switch goes on. – The ultrasonic generator runs through a self-test. 3. During the self-test, check that all indicator lights briefly go on and that a tone can briefly be heard. – All of the indicator lights briefly go on and the tone can briefly be heard. – The self-test has been completed successfully. – The ultrasonic generator is turned on.

Connecting instruments 5.4 Connecting instruments Before connecting an instrument to the ultrasonic generator first ensure via visual check that the instrument is in perfect working order. Connect the instrument cable first, then the irrigation tubing. It is important to con- nect the instrument cable and irrigation tubing to the instrument first and only after- wards to the ultrasonic generator. Use only a sterilized instrument, instrument cable and irrigation tubing to prevent pa- tient infection. Refer to the user manual of the instrument that is used. It describes exactly how to connect the instrument and, for example, whether you need a cover. 5.4.1 Connecting the instrument cable to the instrument Improperly connected instrument cable An improperly connected instrument cable may cause the connector socket to melt. This may cause a malfunction of the ultrasonic generator resulting in serious injury to patients. Treatment must then be performed with an identical or comparable system, thereby prolonging the duration of treatment.  Correctly connect the instrument cable. The instrument cable must be fully in- serted into the connector socket. Liquid on the contacts The connector socket may melt due to the presence of liquid on the contacts of a connector socket or the instrument cable. This may cause a malfunction of the instru- ment and the ultrasonic generator. Treatment must then be performed with an iden- tical or comparable system, thereby prolonging the duration of treatment.  Make sure the contacts on the connector sockets and on the plugs are dry.  Follow the specified sequence of the steps so no liquid gets onto the contacts.

23 Connecting instruments Requirements  The ultrasonic generator is turned on.  The instrument and instrument cable have been sterilized. Procedure 1. Insert the instrument cable into the connector socket on the instrument. Observe the markings. – The instrument cable engages in the connector socket. 2. Fully insert the instrument cable into the connector socket on the ultrasonic gen- erator. Observe the markings. – The OK indicator light on the ultrasonic generator goes on. 5.4.2 Connecting the irrigation tubing to the instrument Requirements  The instrument cable is connected to the instrument.  The irrigation tube has been sterilized. Procedure 1. Connect the irrigation tubing with the luer lock port or instrument irrigation. Hand tighten only. – The irrigation tubing is connected to the instrument.

Connecting irrigation 5.5 Connecting irrigation Install an irrigation bottle and connect the irrigation tubing already connected to the instrument to the irrigation. Fig. 5.1 Connection principle for irrigation Requirements  The instrument cable is connected to the instrument.  The irrigation tubing is connected to the instrument. Procedure 1. Close the roller clamp on the irrigation tubing. 2. Insert the spike into the irrigation bottle. 3. Hang the irrigation bottle onto the irrigation holder. 4. Open the vent on the drip chamber and fill it up to a third full. – The irrigation bottle is installed. 1 Irrigation pump 2 Ultrasonic generator 3 Irrigation holder 4 Irrigation bottle 5 Spike and drip chamber 6 Irrigation tubing 7 Roller clamp 8 Instrument 8 3 4 5 6 7 2 1

25 Connecting irrigation Danger of crushing Rotating parts in the open irrigation pump may cause injury to fingers when the irri- gation tubing is being inserted.  Do not reach inside the irrigation pump. 5. Open the irrigation pump. To do this, push the lever to the left. 6. Move both locking clamps into the upper position. To do this, press on the locking clamps and slide them up.

Connecting irrigation 7. Insert the reinforced part of the irrigation tubing into the irrigation pump. Make sure the irrigation tubing is positioned below the locking clamps. 8. Close the irrigation pump. To do this, push the lever to the right.

27 Connecting irrigation 9. Fix the irrigation tubing into place with both locking clamps. To do this, press on the locking clamps and slide them down. 10. Release the roller clamp on the irrigation tubing. – The irrigation tubing has been fixed in place. – Irrigation is connected.

Preparing for treatment 6 Operation Prior to initial and each subsequent treatment the ultrasonic generator must be cleaned and disinfected (see chapter 7 Reprocessing on page 35). Prior to each treatment functional testing of the ultrasonic generator must be per- formed and the ultrasonic generator's power settings must be checked (see chapter 6.1.2 Functional testing on page 29). Only then may treatment be started. During treatment, keep an identical or comparable system ready for use in case the first one fails. Following treatment, disposable accessories must be properly disposed of. The ultra- sonic generator, the instrument and the accessories must be reprocessed (see chap- ter 7 Reprocessing on page 35). 6.1 Preparing for treatment 6.1.1 Adjusting the volume An activation tone signals that ultrasonic power is being delivered to the instrument. The volume of the activation tone can be set using the volume control. Adjustment of the volume only affects the activation tone. The setting has no effect on the volume of the alarm tones. The activation tone can be turned off by turning the volume control all the way to the left. It is however not recommended to turn the volume all the way down. For functional testing the volume control has to be turned all the way to the right. Procedure 1. To lower the volume, turn the volume control to the left. To raise the volume, turn the volume control to the right. – The volume has now been adjusted.

29 Preparing for treatment 6.1.2 Functional testing Prior to each treatment functional testing of the ultrasonic generator must be per- formed with the instrument being used. Ultrasonic power and irrigation flow on the ultrasonic generator must then be checked and adjusted. Requirements  The instrument has reached the permissible temperature for use (between 10 °C and 40 °C (50 °F and 104 °F)).  The instrument is connected to the ultrasonic generator.  The OK indicator light is on.  Turn the volume control all the way to the right. Procedure 1. Hold the instrument to keep the sonotrode from touching anyone. 2. Press and hold the button to fill with irrigation solution until irrigation solution emerges at the sonotrode of the instrument and no more air is trapped in the irri- gation tubing. 3. Ensure the connections between the irrigation tubing and instrument and be- tween the irrigation tubing and irrigation bottle are leak-free. 4. Briefly activate the instrument with the foot switch. – The indicator light for instrument activity goes on. – An activation tone sounds. – Functional testing has been performed. 5. Check and adjust the power settings (ultrasonic power and irrigation flow). – All power settings have been adjusted. – Treatment can be performed.

Starting treatment 6.2 Starting treatment Only personnel who have been properly instructed in the handling of the ultrasonic generator may begin treatment (see chapter 2.2 Selection and qualification of specialist staff on page 7). Handling the instrument Always use the instrument with care to prevent damage to the sonotrode. Do not bend the sonotrode or touch any metal objects with it. The tissue effect is controlled primarily by ultrasonic power. Due to frictional heat, it is also crucial for the outcome of treatment that the correct amount of pressure is ap- plied to the tissue and that the sonotrode tip is moved correctly over the tissue. Monitor the route of the instrument cable during the treatment. Personnel may not be impeded. They could fall and patients be injured by the sudden movement from the fall. Ultrasonic power It is crucial for the outcome of treatment that the power settings are correct. The higher the ultrasonic power is set, the stronger the tissue effect. If the ultrasonic power is set too high at the beginning of treatment it can have an un- intentionally strong effect and severely injure the patient. Treatment should therefore start at low ultrasonic power to prevent an unintentionally strong effect. Slowly in- crease the ultrasonic power until the desired power is reached. If the ultrasonic power is set too low, the tissue effect may be too weak. Adjust the ul- trasonic power to achieve the desired tissue effect. Irrigation flow Irrigation flow that is set too low or too high may cause damage to tissue. Do not set irrigation flow too low because this may cause tissue damage from over- heating. But also do not set irrigation flow too high, impeding a clear view of the tissue. Con- tinuously monitor irrigation during treatment.

31 Starting treatment Contaminated instruments The use of contaminated instruments may result in life-threatening infections in both patients and users.  Use only a sterilized instrument.  Only use a sterilized instrument cable.  Use only sterilized accessories (irrigation tubing, cover). Instrument remains active An instrument that remains active because, for example, the foot switch does not switch off may result in severe injury to the patient.  Hold the instrument away from the patient.  Turn off the ultrasonic generator. Unintentional activation of the foot switch An unintentionally activated instrument can result in severe injury to the patient.  Position the foot switch so it cannot be activated unintentionally or mistaken for other foot switches.  Place the instrument on a utility table, not on the patient.

Ending treatment 6.3 Ending treatment After treatment, the ultrasonic generator must be turned off. The instrument must then be disconnected and the accessories must be detached from the ultrasonic gen- erator. 6.3.1 Turning off the ultrasonic generator Procedure 1. Turning off the ultrasonic generator using the power switch. – The ultrasonic generator is turned off. 6.3.2 Disconnecting the instrument from the ultrasonic generator Following treatment, the instrument must be disconnected from the ultrasonic gen- erator. Disposable accessories must be disposed of immediately. The instrument and the instrument cable must then be processed. Disconnecting the instrument cable Requirements  The ultrasonic generator is turned off. Procedure 1. Disconnect the instrument cable from the instrument. To do this, pull only on the grip sleeve of the instrument cable. 2. Disconnect the instrument cable from the ultrasonic generator. To do this, pull only on the grip sleeve of the instrument cable. – The instrument cable is disconnected. Disconnecting the irrigation tubing Procedure 1. Close the roller clamp on the irrigation tubing. 2. Disconnect the irrigation tubing from the luer lock on the instrument. – The irrigation tube is disconnected from the instrument. – The instrument is disconnected from the ultrasonic generator and the irriga- tion system.

33 Ending treatment 6.3.3 Detaching the irrigation bottle Requirements  The ultrasonic generator is turned off.  The instrument is disconnected from the ultrasonic generator and the irrigation system.  The roller clamp on the irrigation hose is closed. Danger of crushing When the irrigation pump is open, rotating parts may injure fingers when the irriga- tion tubing is being removed.  Ensure that the ultrasonic generator is turned off before the irrigation pump is opened. Procedure 1. Open the irrigation pump. To do this, push the lever to the left. 2. Remove the irrigation tubing and close the irrigation pump again. To do this, push the lever to the right. 3. Remove and properly dispose of the irrigation bottle along with the irrigation tubing and irrigation holder. – The irrigation bottle is now disconnected. 6.3.4 Disconnecting the foot switch Requirements  The ultrasonic generator is turned off. Procedure 1. Pull the foot switch cable out of the connector socket. Pull on the grip sleeve to do this. – The foot switch is now disconnected from the ultrasonic generator.

Ending treatment 6.3.5 Disconnecting the ultrasonic generator from the main power supply Requirements  The ultrasonic generator is turned off. Procedure 1. Disconnect the power cord from the main power supply and then from the ultra- sonic generator. 2. If required, disconnect the potential equalization cable from the potential equal- ization rail and then from the ultrasonic generator. – The ultrasonic generator is disconnected from the main power supply.

35 Ending treatment 7 Reprocessing After each treatment the ultrasonic generator as well as all instruments and accesso- ries used must be cleaned and disinfected. All instruments and the instrument cable must then be sterilized. Reprocessing the instruments and the instrument cable is not described in these in- structions for use. Follow the relevant instructions for use for reprocessing the instru- ments and the instrument cable. Accessories that must be cleaned and disinfected after each treatment include the power cord, the potential equalization cable and the foot switch with cable. Disposable accessories such as the irrigation tubing must be disposed of in accor- dance with regulations. Prior to reprocessing, turn off the ultrasonic generator and disconnect the power cord from the main power supply. Reprocessing of the ultrasonic generator and the accessories comprises two main steps:  Cleaning  Disinfection Only use disinfectants recommended by the Association for Applied Hygiene (VAH). Also follow the guidelines of the Robert Koch Institute (RKI).

Cleaning the ultrasonic generator and accessories 7.1 Cleaning the ultrasonic generator and accessories Requirements  The instrument cable is disconnected from the ultrasonic generator.  The irrigation tube is disconnected from the ultrasonic generator and has been disposed of.  The foot switch is disconnected.  The power cord and the potential equalization cable are both disconnected from the main power supply. Excessive or improper cleaning agents Excessive or improper cleaning agents may cause damage to the ultrasonic genera- tor.  Clean the ultrasonic generator in a way that prevents the penetration of liquid or moisture.  Do not use any explosive or flammable cleaning agents. Procedure 1. Wipe the ultrasonic generator clean with a moist cloth. 2. Wipe the power cord and the foot switch with a moist cloth. – There is no longer any visible dirt on the ultrasonic generator or the accesso- ries. – The ultrasonic generator and the accessories have been cleaned and are ready for disinfection. 7.2 Disinfecting the ultrasonic generator and accessories Requirements  The ultrasonic generator and the accessories have been cleaned. Procedure 1. Give the ultrasonic generator a disinfective wipe down. 2. Give the power cord and the foot switch a disinfective wipe down. – The ultrasonic generator and the accessories have been disinfected. 7.3

37 Faults 8 Preventive maintenance Maintenance of the ultrasonic generator entails checking the condition of the ultra- sonic generator and the extent of wear at regular intervals. Once per year, have an ex- pert perform a safety check of the ultrasonic generator You can remedy some faults occurring during the self-test or in operation yourself. You may not however perform any repairs yourself. 8.1 Faults 8.1.1 Faults occurring during the self-test The ultrasonic generator detects internal faults during the self-test. Notification of an internal fault happens in three ways:  An alarm tone sounds.  The ERROR indicator light goes on.  A numeric code is displayed. If the self-test is unsuccessful, all functions are blocked. If the internal fault cannot be remedied or if it reoccurs, notify the manufacturer or an authorized distributor. Numeric code Cause of fault Remedy 1.1-1.4 Internal com- puter module Turn the ultrasonic generator off and back on again after 10 seconds. 2.1-2.6 Internal operat- ing voltages Turn the ultrasonic generator off and back on again after 10 seconds. 3.1-3.5 Power supply unit Manufacturer or authorized distributor 4.1 Foot switch de- tection Pull the foot switch cable out of the connector socket. Turn the ultrasonic generator off and back on again after 10 seconds. If the ultrasonic generator is working properly insert the foot switch cable back into the connector socket. Replace the foot switch if necessary. 4.2 Instrument de- tection Disconnect the instruments and accessories from the ul- trasonic generator. Turn the ultrasonic generator off and back on again after 10 seconds. Check the instrument cable and instrument. Replace the instrument cable or instrument if necessary. 5.1 Internal com- puter module Turn the ultrasonic generator off and back on again after 10 seconds.

Faults 8.1.2 Faults occurring during operation During operation, other faults which can be attributed to other influencing factors may occur. Notification of faults detected by the ultrasonic generator is provided in two ways:  An alarm tone sounds.  The ERROR indicator light goes on. When the ultrasonic generator has notified you of a fault, the cause of the fault must be eliminated. However, the ultrasonic generator does not detect all faults. For this reason, note any faults occurring during operation. If you discover a fault, the cause of the fault must be eliminated. Continuing to treat a patient despite the presence of a fault may result in life-threatening injury to the patient. If a fault directly endangers the patient, turn off the ultrasonic generator immediately. Fault Possible cause Remedy Instrument not working. Instrument cable is defective. Replace the instrument cable. Instrument not automati- cally detected. Instrument is defective. Use a different instrument. The OK indicator light flashes during treatment. The pressure applied to the tis- sue by the sonotrode tip is too high. Cease treatment. Reapply the so- notrode tip to the skin. During treatment, an alarm tone sounds and the ERROR indicator light goes on. Instrument is overloaded. Cease treatment. Use a different instrument if necessary. No activation tone sounds. Activation tone has been turned off. Turn the volume control to the right. Instrument cannot be turned off. Foot switch is jammed. Turn off the ultrasonic generator. Activate the foot switch to elimi- nate the jam. Replace the foot switch if neces- sary. Irrigation not working. There is no more irrigation solu- tion in the irrigation bottle. Connect a new irrigation bottle. Irrigation tubing spike is not properly positioned in the irriga- tion bottle. Insert the irrigation tubing spike properly in the irrigation bottle. Check the drip chamber in the pro- cess. Irrigation tubing is not correctly inserted in the irrigation pump. Open the irrigation pump and re- insert the irrigation tubing. The roller clamp on the irriga- tion tubing is closed. Open the roller clamp. Negative pressure is building up in the irrigation bottle because the vent on the drip chamber is not open. Open the vent on the drip cham- ber. Irrigation is improperly set. Adjust irrigation.

39 Safety check 8.2 Safety check A safety check of the ultrasonic generator must be performed once a year. The safety check may only be performed by qualified personnel authorized by the manufacturer using suitable measuring and testing devices. The type and scope of the safety check are prescribed by the manufacturer. The process and results of this safety check must be recorded in a report. 8.3 Repairs If the ultrasonic generator is defective or a fault cannot be remedied, you can send the ultrasonic generator in for repair. Have the ultrasonic generator repaired only by the manufacturer or an authorized distributor. Never attempt to repair the ultrasonic generator yourself. Send only cleaned and disinfected ultrasonic generators in for repair. Additional costs will otherwise be incurred. An irreparable ultrasonic generator must be properly disposed of (see chapter 9 Dis- posal on page 40). 8.4

9 Disposal If the ultrasonic generator or accessory has reached its end of life, you must ensure its proper disposal. An improperly disposed of ultrasonic generator or improperly dis- posed of accessory may cause damage to the environment. Give the ultrasonic generator or accessory to a disposal company. You can also send in the ultrasonic generator to the manufacturer or an authorized distributor for dis- posal. Only hand over a cleaned and disinfected ultrasonic generator or cleaned and disin- fected accessory for disposal, because any contamination may cause life-threatening infections in people. 9.1

41 10 Technical data 10.1 SONOCA 185 Dimensions: Width: 370 mm, height: 160 mm, depth: 390 mm Weight: 13.0 kg Output voltage: 230 V ± 10% 115 V ± 10% 100 V ± 10% Current consumption: max. 0.6 A max. 1.2 A max. 1.4 A Power fuse (2 thermal fuses each): T1.25AH T2.5AH T3.15AH Frequency: 50 Hz to 60 Hz ± 5% Power consumption: Max. 140 VA Temperature: Operation: 10 °C to 40 °C (50 °F to 104 °F) Transport and storage: –20 °C to 50 °C (-4 °F to 122 °F)) Relative humidity: Operation: 20% to 80%, non-condensing Transport and storage: 20% to 85%, non-condensing Air pressure: Operation: 700 hPa to 1060 hPa (10.2 psi to 15.4 psi) Transport and storage: 700 hPa to 1060 hPa (10.2 psi to 15.4 psi) Maximum activation time: Depends on the instrument No longer than 60 minutes total Frequency range of oscillator: 20 kHz to 80 kHz Working frequency: 25 kHz, 35 kHz Electrical output power: Maximum 60 W Irrigation flow: Depends on the instrument, maximum 150 ml/min Classification: Protection class I (in accordance with IEC 60601-1), Type BF (in accordance with EN 60601-1), Class IIb (in accordance with German Medical Devices Act and directive 93/42/EEC, Annex IX), German Ordinance on the Installation, Operation and Use of Medical Products (MPBetreibV)

11 Electromagnetic compatibility The ultrasonic generator meets the requirements of IEC 60601-1-2 for electromag- netic compatibility.

43

11.1

45 Index A Accessories cleaning 36 disinfecting 36 disposing of 40 reprocessing 35 Activation tone 28, see also Alarm tone Adjusting the irrigation flow 14 ultrasonic power 14 Alarm tone 28, 37, 38, see also Activation tone Association for Applied Hygiene (VAH) 35 At risk patient 9 B Bone instrument 17 Button for decreasing ultrasonic power 14 for direct selection of the ultrasonic power 14 for filling the irrigation tube 14 for increasing the irrigation flow 14 for increasing ultrasonic power 14 for reducing the irrigation flow 14 C Check, safety 39 Cleaning 36 Cleaning agent 36 Compatibility, electromagnetic 42 Conditions for handling the ultrasonic generator 6 general 6 Connection for the potential equalization cable 11 of the potential equalization cable 20 of the power cord 20 Connector socket for a foot switch 10 for an instrument 10 for the power cord 11 Contaminated instrument 31 Contamination, see Cleaning D Digital display 15 Disinfection 36 Display for the irrigation flow 14 for ultrasonic power 14 Display panel 10, 15 Disposable accessories, disposing of 35 Disposal 40 Drip chamber 24 E Electromagnetic compatibility 42 F Fail-safe operation 28 Fault 37 during operation 38 during self-test 37 Foot switch connecting 20 disconnecting 33 jammed 38 single 17 Functional testing 28, 29 Fuse holder 11 H Handling the ultrasonic generator, conditions for 6 High-frequency current 9 I Improper handling 19 Indicator light, see also Digital display ERROR 15, 37, 38 for instrument activity 14 OK 15, 38 Initial start-up 21 Installation 19, 19

Index Instructions for use, see Instructions for use for the instruments 5 for the ultrasonic generator 5 purpose of the 5 Instrument contaminated 31 disconnecting from the ultrasonic generator 32 not working 38 reprocessing 35 Instrument cable 17 connecting 22 disconnecting 32 Instrument detection, not working 38 Intended use 7 Interference, electromagnetic 42 Irrigation connecting 24 not working 38 Irrigation bottle 17, 24 detaching 33 installing 24 Irrigation flow 30 adjusting the 14 Irrigation holder 24 Irrigation pump 10, 11, see Irrigation pump, see Ir- rigation pump, danger of crushing 33 Irrigation tubing 17, 24 connecting 23 disconnecting 32 L Loudspeaker 11 M Main power supply 19, see Main power supply N Numeric code 37, see Numeric code O Operating environment 8 Operation 28 Operator control panel for irrigation 10, 14 for ultrasonic power 10, 14 Overview 10 P Packaging 18 Pictogram foot switch 12 hazardous waste 12 high voltage 12 instrument 12 non-ionizing radiation 12 on the ultrasonic generator 12 potential equalization 12 read the instructions for use 12 type BF 12 Potential equalization cable 19 connecting 20 connection for the 11 disconnecting 34 Power cord 19, see Power cord connecting 20 disconnecting 34 Power setting 30 Power switch 10 Preventive maintenance 37 Procedure time 8 Prohibition sign 9 Q Qualification, see Specialist staff R Repair 39 Reprocessing 35 prior to initial use 28 Robert Koch Institute (RKI) 35 Roller clamp 24 S Safety check 39, 39 Safety notice, see Warning Scope of delivery 16 Serial plate 11, 13 Signal tone, see Alarm tone Signal word 5

47 Specialist staff, qualified 7 Spike 24 Start-up 19, 21 Storage 18, see Storage Storage environment 18 System overview 17 T Technical data 41 Transport 18 Treatment ending 32 starting 30 tasks prior to 28 Treatment duration 8 Turning on 21, see Turning on U UAW handpiece 17 Ultrasonic generator cleaning 36 conditions for handling 6 connecting to the main power supply 19 defective 39 disinfecting 36 disposing of 40 irreparable 39 overview of 10 reprocessing 35 system overview 17 turning off 32 turning on 21 Ultrasonic power 30 button for decreasing 14 button for increasing 14 buttons for direct selection of the 14 Usage, see Intended use Use, see Intended use, see Treatment, intended 7 V Volume, adjusting the 28 Volume control 11 W Warning 5 Warning sign 9 Wipe disinfection 36

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