Misonix sonicone Clinic Instructions For Use Manual
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Misonix sonicone Clinic Instructions For Use Manual

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Instructions For Use
SonicOne Clinic Powered by Misonix

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  • Page 1 Instructions For Use SonicOne Clinic Powered by Misonix...

  • Page 2: Table Of Contents

    Indications ..............................14 2.2. Contra Indications ............................. 14 Adverse Effects ..............................14 Considerations During Clinical Use ......................15 4.1. SonicOne CLINIC Use ..........................15 System Overview ..............................17 5.1. Principle Of Operation ..........................17 5.2. Reusable System Components ......................18 5.3.

  • Page 3: General Safety Statements

    The SonicOne CLINIC system is to be used by an appropriately trained and licensed healthcare practitioner. 1.1. EMC Statement The SonicOne CLINIC system is designed and tested to comply with FCC regulations for conducted and radiated emissions under Part 18 Subchapter J. and to comply with IEC EN60601-1-2 guidelines for EMC. CAUTION 1.2 This device is considered medical electrical equipment.
  • Page 4 Guidance And Manufacturer’s Declaration – Electromagnetic Emissions (Table 201) The SonicOne CLINIC SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of SonicOne CLINIC SYSTEM should ensure that it is used in such an environment.
  • Page 5 Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 202) The SonicOne CLINIC SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of the SonicOne CLINIC SYSTEM should assure that it is used in such an environment.
  • Page 6 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SonicOne CLINIC SYSTEM is used exceeds the applicable RF compliance level above, the SonicOne CLINIC SYSTEM should be observed to verify normal operation.

  • Page 7: Electrical Safety Statement

    The SonicOne CLINIC system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SonicOne CLINIC System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SonicOne CLINIC system below, according to the maximum output power of the communications equipment.

  • Page 8: Environmental Statement

    However, the user is advised to read the entire manual and operate the device only in accordance with all of the instructions contained herein. Servicing of this device should only be performed by qualified technicians authorized by Misonix, Inc. There are no service controls accessible to the user.
  • Page 9 WARNING 1.2 The SonicOne CLINIC system is intended to be used in various types of invasive, surgical procedures. There may be indirect danger to the patient should the device fail during the procedure. It is recommended that the facility follows its back-up equipment protocols.
  • Page 10 Personal injuries may result. Cooling of the ultrasonic tip and irrigation at the treatment site will be inhibited. WARNING 7.3 Tip and irrigation temperatures may exceed the tissue necrosis point with SonicOne CLINIC accessories for hard tissue removal if insufficient irrigation flow rates are used. Always set the irrigation flowrate for hard tissue removal to a setting no less than the comparable vibration setting.
  • Page 11 Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.  The SonicOne CLINIC system is to be used by an appropriately trained and licensed healthcare practitioner. CAUTION 1.2 This device is considered medical electrical equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this operator’s manual.
  • Page 12 Do not use ultrasonic cleaners to clean the handpiece as both methods could damage handpiece. CAUTION 12.1 Use only genuine replacement parts from Misonix. Use of parts furnished by other sources may result in patient or operator injury or system malfunction and will void any applicable warranty.

  • Page 13: Trademark Information

    1.5. Trademark Information Misonix® and SonicOne® are registered trademarks of Misonix, Inc., Farmingdale, NY ASP Enzol® and Prolystica® are registered trademarks of STERIS Corporation, Mentor, OH Steris® is a registered trademark of Steris Corporation Mentor, OH...

  • Page 14: Explanation Of Symbols

    AC Voltage Lot or batch code greater than indicated Must use hospital grade power cord Manufacturer Fuse only Misonix CE Footswitch Classified by UL number connector Irrigation Source Contains DEHP Vacuum source and/or Phthalates Table 1.6 Explanation of symbols...

  • Page 15: Indications And Contra Indications

    2. Indications And Contra Indications 2.1. Indications The SonicOne CLINIC® is Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery •...

  • Page 16: Considerations During Clinical Use

    After extended periods of operation, the bottom of the console housing may become warm to the touch. This is normal. Do not touch the bottom of the console housing while in operation or shortly after operation. 4.1. SonicOne CLINIC Use Recommended Settings The following settings are general guidelines and should be adjusted based on indication, anatomy, pathology and surgeon’s...
  • Page 17 The SonicOne Clinic reusable tips are used for soft tissue wound debridement. The SonicOne Clinic may be used with Misonix SonicOne OR or BoneScalpel sterile, single use disposable tips. BoneScalpel tips are used for bone cutting and bone shaving in cases where bone is involved in the wound. Some SonicOne OR tips offer a vacuum sheath for aspiration of irrigation fluid and reduction in spray.

  • Page 18: System Overview

    5. System Overview 5.1. Principle Of Operation The SonicOne CLINIC system is designed to ultrasonically dissect and fragment soft and hard tissue. The system consists of an ultrasonic console with handpiece and accessories. The console features an integrated irrigation pump.

  • Page 19: Reusable System Components

    A peristaltic pump, integrated into the SonicOne CLINIC console, provides irrigant (sterile physiological saline) to the operative site during use. 5.2. Reusable System Components The following system components represent the minimum requirements for performing soft and hard tissue procedures. They can be ordered as a system or individually.
  • Page 20 5.3. Autoclavable Debridement Probes Components and quantities included with the system may change over time, please check with your Misonix representative for the most current configuration. Ultrasonic probes are supplied NON Sterile and can be reused. At least one of the following probes must be available for each surgical procedure.

  • Page 21: Single Use, Sterile Components

    5.6 Additional Probe Tips The SonicOne Clinic console may be used with Misonix SonicOne OR or BoneScalpel sterile, single use disposable tips. BoneScalpel tips are used for bone cutting and bone shaving in cases where bone is involved in the wound. Some SonicOne OR tips are offered with an aspiration sheath for irrigation aspiration and spray reduction.

  • Page 22: Menu Functions

    Indicator for flow direction Irrigation pump head A-F Custom buttons Figure 6.1.2 SonicOne Clinic Console Front Buttons A-F perform various functions, depending on the information displayed on the screen. The display screen shown is the Main Screen used for all major control functions.
  • Page 23 Menue Bottons A-F Custom Buttons 6.2.1 Main screen Amplitude Control The amplitude can be set between 0 and 10. Press A to increase and B to decrease the amplitude in increments of 1. The default setting for amplitude is 7. Refer to section 1.1 for further details on the Amplitude feature. Pulse Control The pulse can be set between 50% and 100%.

  • Page 24: Main Functions

    Help Screen The Help Screen provides access to a quick guide on system operation and troubleshooting. Menu Button Software Revision A-F Custom buttons A B C D Figure 6.2.3 Help screen System Operation Press A to access the quick reference guide on system operation. Troubleshooting Press B to access the quick reference guide on troubleshooting.
  • Page 25 Pulse Setting 50-90% [Pulsed] The Pulse function minimizes exposure to ultrasound over time. The Pulse setting corresponds to the duration of the active period of the ultrasound output. For example, a Pulse setting of 60% corresponds to an active period of 60% of ¼ second (150ms). The resulting resting period is 40% of ¼ second (100ms). The ultrasonic energy output over time is reduced by 40% with this setting.

  • Page 26: Alerts And Indicators

    Standby Mode Enable Mode Amplitude setting is GREY and HOLLOW Amplitude setting is GREEN and SOLID Footswitch activates Footswitch activates • Irrigation only. Irrigation can be used for lavage or • Ultrasound output and irrigation. A bell chime is emit- priming.
  • Page 27 Tip overload can occur during hard tissue removal when applying excessive tip pressure or facing strong tissue resistance, e.g. from thick cortical bone. This can lead to stalling of the ultrasonic tip. A pulsed audible signal alerts of the stalling and the ultrasound is deactivated.

  • Page 28: System Set-Up

    7. System Set-up 7.1. Installation Upon delivery perform a visual inspection of the shipping containers and all system components for obvious shipping damage. Retain the shipping container and immediately notify the shipping carrier of any damages found. CAUTION 7.1 All reusable system components like handpiece, probe front housing, counter wrench, and T-wrench and autoclavable probe tips are supplied industrially cleaned, but NON-STERILE.

  • Page 29: Console Set-Up - Part I (Non-Sterile)

    The console features air vents on the bottom. When installing the unit, ensure that these vents are not blocked in a way that would prevent the circulation of air around the unit. 1 Air vents Figure 7.1.2 Underside view of console with air vents NOTE 7.1 Adequate air circulation is needed to cool electronic components inside of the unit.

  • Page 30: Handpiece Assembly (Sterile)

    7.3. Handpiece Assembly (Sterile) Handpiece assembly in the sterile field should be performed by trained OR staff only. Please refer to section 8.0 for specifics on the handpiece assembly and disassembly. Once the handpiece has been assembled, continue with part II of the Console Set Up. CAUTION 7.2 All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions before each Clinical use.

  • Page 31: Console Set-Up - Part Ii (Non-Sterile)

    7.4. Console Set-up – Part II (Non-sterile) Console Set-up | Part II Connect Handpiece cable Attach cable connector receptacle on console front panel. Align red dot on cable connector with red dot on front panel receptacle. Push cable connec- tor into place. Open the latch of the irrigation pump Open pump cover The arrow on the pump housing indicates the direction of flow.
  • Page 32 If no irrigant is flowing, cease use until flow is restored. WARNING 7.3 Tip and irrigation temperatures may exceed the tissue necrosis point with SonicOne CLINIC accessories for hard tissue removal if insufficient irrigation flow rates are used. Always set the irrigation flowrate for hard tissue removal to a setting no less than the comparable vibration setting.

  • Page 33: Perform System Check

    The system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction. The SonicOne CLINIC system is now ready for use. Refer to section 1.0 for general safety statements, indications and adverse effects and section 5.0 for use of main system functions.
  • Page 34 Table 8.2 Handpiece Assembly for debridement E-SOUM-PLUS Rev E...

  • Page 35: Handpiece Disassembly

    The handpiece is now ready for use and can be connected to the SonicOne CLINIC system. Please refer to Section 7.0 for details. If desired, mount suitable sterile cable clips or sterile adhesive tape strips to attach irrigation tubing to handpiece cable.
  • Page 36 Table 8.2 Irrigation tube and handpiece disassembly Once irrigation tube is disconnected, please see the selected tip’s (i.e., MXB-20) Instructions For Use (included in the sterile packaged product) for disassembly instructions. E-SOUM-PLUS Rev E...

  • Page 37: Cleaning And Sterilization

    9. Cleaning And Sterilization Follow manufacturer’s directions for preparing solutions. Misonix recommends the use of CaviWipes® or equivalent quaternary ammonium compound surface disinfectant wipe. Please follow manufacturer’s instructions for surface cleaning and disinfection of hard non porous surfaces, including, without limitation, the use of personal Protection Equipment (PPE) for Blood borne Pathogens.

  • Page 38: Cleaning

    Misonix Inc. has validated all cleaning and sterilization cycles given in this manual. It is highly recommended that the procedures given in this manual for cleaning and sterilizing the SonicOne CLINIC System and related accessories be followed. It is the responsibility of the user of this device or any accessories used with it to validate procedures for cleaning and/or sterilization if they differ from the procedures as outlined in this manual.
  • Page 39 Console and Footswitch Wipe Surfaces • Follow manufacturer’s directions for preparing solutions. Misonix recommends the use of CaviWipes1 ® or an equivalent quaternary ammonium compound surface cleaning and disinfection wipe. Wipe footswitch and console, including irrigation unit, with cloth or absorbent paper moistened with an enzymatic detergent such as ASP Enzol®...
  • Page 40 9.2.2 Automated Wash Procedure Handpiece, Probe, Probe Cover and Wrenches Point of Use Immediately following procedure perform the following: • Flush handpiece lumen with minimum 100 mL of saline to clear the bore of debris. • Wipe all reusable devices to remove visible blood and debris. CAUTION: DO NOT use saline to wet the tray and tray contents before transport to the decontamination processing area.

  • Page 41: Sterilizing By Steam Autoclave

    E-PWRCH T-Wrench E-CWRCH Handpiece/Counter Wrench BCM-H2 Soft Tissue Probe Cover 9.3.1 Validated Steam Sterilization Cycles SonicOne Clinic Handpiece With Sterilization Tray 134-137°C 132°C (270°F) (274-279°F) Items placed in Misonix Sterilization Items placed in Misonix Sterilization Configuration Tray E-SYSTRAY or E-SYSTRAY-2...
  • Page 42 *Exposure time can be increased up to a maximum of 18 minutes to comply with local requirements and/or recommenda- tions of the World Health Organization (WHO), Robert Koch Institute (RKI), etc. Misonix Inc. reusable medical devices are able to sustain such sterilization cycles.

  • Page 43: Expected Life, Reusable Components

    9.5 Deviations From Decontamination, Cleaning And Sterilization Instructions Misonix Inc. has validated all cleaning, disinfection and sterilization cycles given in this manual. It is highly recommended that the procedures given in this manual for cleaning and sterilizing the SonicOne CLINIC system and related accessories be followed.
  • Page 44 Corrective Action Possible Cause Release footswitch. Tip overload Reduce tip pressure and/or use higher amplitude setting as required. Continue procedure. Release footswitch. Set ultrasound to STANDBY. Remove silicone sleeve (if applicable) and probe cover. Loose or Inspect extension probe and ultrasonic tip for damage. Replace if necessary. damaged component Otherwise re-tighten extension probe and tip using the correct wrenches.
  • Page 45 Do not operate pump with pump cover in raised position. Rollers might pinch loose clothing or fingers. Personal injuries may result. Cooling of the ultrasonic tip and irrigation at the treatment site will be inhibited. For all other malfunctions please contact Misonix or a Misonix authorized representative for service. E-SOUM-PLUS Rev E...

  • Page 46: Specifications

    11. Specifications Console Specifications Power input (E-SOP-GEN) • 120VAC, 4 Amps, 60Hz • 220/230/240 VAC, 2.5 Amps, 50/60 Hz Power input (E-SOP-GEN-100V) • 100VAC, 6.3 Amps, 50/60Hz • 200 VAC, 3.15 Amps, 50/60Hz Operating frequency 22.5 kHz Ground leakage current 300 µA (max.) Output power 130 Watts (max.)

  • Page 47: Service, Repair And Technical Correspondence

    BCM-H2 Soft Tissue Probe Cover 2 ea. able 11.2 System contents Components and quantities included with the system may change over time, please check with your Misonix representative for the most current configuration. UL (IEC) 60601-1 Classification Class 1 Equipment...
  • Page 48 Model BCM-GN-100V Fuse Specifications Line Voltage Manufacturer Manufacturer P/N Rating Description Fast Acting, Low Break- 100 VAC, 50/60 Hz Cooper/Bussman GDB-6.3 250V @ 6.3 A Fast Acting, Low Break- 200 VAC, 50/60 Hz Cooper/Bussman GDB-3.15 250V @ 3.15 A Table 12.2 Console fuse specifications model Fuse Replacement (The fuse holder is located on the console rear) Switch to Standby Mode using enable/standby button.

  • Page 49: Pump Head Replacement

    12.2 Pump Head Replacement The pump head may not be connected to the unit for shipping purposes. Mount Pump Head Shaft recess and bayonet fitting on Pump drive shaft on console front pump head rear Position Pump Head Align drive shaft on console front and shaft recess on pump head rear.

  • Page 50: Repair, Service And Replacement Parts

    12.3 Repair, Service and Replacement Parts All requests for repairs and replacement parts should be directed to Misonix or an authorized Misonix representative. Always provide model and serial number of malfunctioning items. When returning items include model, serial and RMA number as well as purchase order number on all documents. Always prepay return shipping and specify method of shipment.

  • Page 51: Important Notice

    U.S.A. By returning any material to Misonix, Inc. the customer or the customer’s agent must certify that any and all materials so returned are or have been rendered free of any hazardous or noxious matter or radioactive contamination and are safe for handling under normal repair shop conditions.
  • Page 52 +1.631.694.9555 phone +1.631.694.3285 FAX 1938 NEW HIGHWAY, FARMINGDALE, N.Y. 11735, U.S.A. MISONIX, INC. NASDAQ SYMBOL. MSON © 2018 Misonix, Inc. All rights reserved. Printed in the USA. E-SOUM-OR Rev P E-SOUM-OR Rev M...

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