Related Manuals for Misonix SonaStar SYSTEM-M300-0 Series
Summary of Contents for Misonix SonaStar SYSTEM-M300-0 Series
- Page 1 Instructions For Use Models with serial #’s that begin with FHF SYSTEM-M300 SYSTEM-M360 SYSTEM-M380...
- Page 2 IFU-607 Rev D P age 1 of 65...
-
Page 3: Table Of Contents
Table of Contents General Safety Statements ..................................3 1.1. Summary of Safety Notices: Warnings, Cautions and Notes..........................3 1.2. EMC Statement ........................................6 Electrical Safety Statement ..................................... 10 Environmental Statement ....................................10 FCC Statement ........................................11 Trademark Information ..................................... 11 Explanation Of Symbols ..................................... 12 Indications And Contraindications ................................ -
Page 4: General Safety Statements
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 5 WARNING 9.3 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 SonaStar 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 6 Replacement fuses must be identical in type, voltage rating and current rating to the original fuse. CAUTION 12.2 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 7: Emc Statement
The SonaStar is configured for a specific electrical input (line) at the factory before shipment, and is not intended to be configured or changed in the field except by Misonix authorized technical personnel. The unit may only be used with the electrical input originally intended. - Page 8 in which it will be used. Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601-1-2:2007) Guidance And Manufacturer’s Declaration – Electromagnetic Emissions (Table 201) The SONASTAR SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of SONASTAR SYSTEM should ensure that it is used in such an environment.
- Page 9 The SONASTAR SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of the SONASTAR SYSTEM should assure that it is used in such an environment. IEC 60601 Immunity test Compliance level Electromagnetic environment – guidance test level o ±6 kV contact o ±6 kV contact...
- Page 10 Guidance And Manufacturer’s Declaration – Electromagnetic Immunity (Table 204) The SONASTAR SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of the SONASTAR SYSTEM should assure that it is used in such an environment. Compliance Immunity test IEC 60601 test level...
-
Page 11: Electrical Safety Statement
Do not attempt to remove or disassemble the cover. There are no user-serviceable parts inside the console. All service should only be performed by an authorized Misonix representative. No modification of this equipment is required. WARNING 1.4 Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. -
Page 12: Fcc Statement
® ® ® Misonix , SonaStar and OsteoSculpt are registered trademarks of Misonix, Inc., Farmingdale, NY ® ® ASP Enzol and Prolystica are registered trademarks of STERIS Corporation, Mentor, OH Force FX™ and Valleylab™ are trademarks of Covidien AG, Switzerland ConMed System 2400™... -
Page 13: Explanation Of Symbols
1.7 Explanation Of Symbols Console Related Symbols Symbol Description Symbol Description Symbol Description Danger: High Voltage. No Footswitch protected not remove cover. IP68 Mains Power ON against immersion Contact service personnel. Not for use in the Caution: vicinity of flammable Consult accompanying Mains Power OFF anesthetics, oxygen... - Page 14 Misonix CE Classified by UL Setup number Handpiece faces this side- Marking on Torque Remote IR receiver Handpiece This Side Remove Remove probe tip wrench Torque Tighten probe tip Linear Mode Preset Mode Vibration Elapsed time Lap Mode Replace wireless...
-
Page 15: Indications And Contraindications
2. Indications And Contraindications 2.1. Indications The SonaStar Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery... -
Page 16: Principle Of Operation
4. Principle of Operation 4.1. Ultrasonic Theory The Ultrasonic Aspirator achieves surgical fragmentation and excision of tissue by high frequency vibration of the titanium tip connected to the handpiece. The application of the vibrating tip to the tissue results tissue ablation. Once the contact has been established between the tip and the target tissue, two ablation effects are noted: (1) The most prominent effect is cavitation. - Page 17 4.2.1. Irrigation System Irrigating solution is provided to the distal end of the tip to suspend fragmented particles, prevent clogging of the aspiration system and to cool the tip and handpiece. The irrigating solution (sterile IV) is routed from the IV bag (or equivalent), through an irrigation pump, to the tip of the handpiece.
- Page 18 4.2.6. Wireless Footswitch An infrared, multi-pedal, wireless footswitch communicates, via infrared signals, with two integrated IR receivers and an optional remote IR receiver. The first integrated IR receiver is mounted on the top of the SonaStar console, the second, on the console left side, above the handle bar. Together they facilitate wireless communications in the standard operating room environment.
-
Page 19: Reusable System Components
4.3. Reusable System Components The following reusable system components are required for performing procedures. They can be ordered as a system or individually. Console Configurations and Reusable Accessories SonaStar System (115/230V System) SYSTEM – M360-0* Includes generator console, wireless footswitch, remote IR receiver, autoclavable torque wrench, SYSTEM –... -
Page 20: Single-Use, Sterile Components
Please contact Misonix directly if you have any questions regarding compatibility issues. There are a variety of ultrasonic tips available for the SonaStar system. Please ask your Misonix representative for the latest catalog of available tips. Ultrasonic tips are supplied sterile and are for single use only. -
Page 21: Optional Accessories For Monopolar Coag
4.5. Optional Accessories for Monopolar COAG To perform monopolar COAG, the following items are needed. (See Chapter 8 for more information on use of COAG): Approved electrosurgical generator, see Section 8.1. 2) Appropriate umbilical cable, see Table Single-Use Monopolar Handpiece Cable, see Table Accessories for Monopolar COAG CFSM6-C140 Valley Lab Force 2 Electrosurgery Generator Umbilical Cable –... -
Page 22: Front Panel Controls
Figure (1) Handpiece Connector - The handpiece receptacle is keyed in order to facilitate connection. The red dot on the receptacle must be in line with the corresponding red dot on the handpiece cable. (2) Tissue Release Valve – This is a pinch-off valve through which the suction tubing is routed. During standard operation (vibration footswitch depressed), it is open and then closes for ½... - Page 23 When the COAG button is depressed, the irrigation pump is inactive and the bar graph displays a single bar at the preset level. When any foot pedal is released, irrigation will continue to flow at a rate of approximately 2cc/min for 2 minutes.
- Page 24 (3) Vibration Level Display & Controls: The blue bar graph display indicates the vibration level set by the user. The vibration level may be adjusted by pressing the “Increase” ▲ (3A) or “Decrease” ▼ (3B) buttons located to the right of the illuminated scale. The excursion (displacement) at the tip is a function of the vibration setting. At the maximum setting of ‘100’, the tip excursion (displacement) is approximately 300 microns for the Curved Extended Handpiece and approximately 225 microns for the Short Straight Handpiece.
-
Page 25: Rear Controls, Labeling, Storage And Receptacles
turned on, the Setup key LED flashes to indicate that the Setup key must be pressed to initiate the system self-test procedure. Please make sure that the system has been set up properly according to Chapter Error! R eference source not found., including handpiece connection. Pressing the key will initiate testing of the vibration system to verify that the handpiece tip is properly tightened and that the handpiece is functioning properly. - Page 26 External Aspiration Filter Assembly: External (visible) and internal vacuum filters. See Section 9.6, page 53. Footswitch Storage Shelf Electrosurgery Umbilical Connector: provides for connection to a Misonix-approved electrosurgical unit. See Chapter 8 for more details. Power cord receptacle: Location of Fuses - F1 and F2 (see Section 12.1 for replacement).
- Page 27 20 Vacuum Port Tubing Connection 21 Handpiece Tubing Connection 22 Carbon Filter Suction Tubing Connection 23 External Vacuum Filter Tubing Connection 24 Carbon Filter Tubing Quick Connect 25 Activated Carbon Filter With Attached Tubing Figure 5.6 Lower Console rear view (canister/filter connections) Vacuum port tubing connection: One end of the 3 ft.
-
Page 28: Wireless System Receptacles, Controls And Indicators
>25cc/min. When used with an electrosurgery unit: The SonaStar can only activate the COAG function if an authorized electrosurgery unit is connected via an umbilical cable connector, available from Misonix. • COAG - When the footswitch button (4) is depressed, the COAG function will be activated on the electrosurgical unit via the umbilical cable connected to an authorized electrosurgical unit. - Page 29 footswitch release; this is normal. If the footswitch signal is blocked or otherwise interrupted, activation will cease after approximately 2 seconds. Please refer to Figure starting on 29 for a chart that summarizes the functions of aspiration, irrigation and vibration 5.10 based upon the of the functions of the footswitch, i.e.
- Page 30 Standard Operation – Foot Pedal Functions Irrigation Aspiration Vibration Vibration Foot Pedal • All of the display bars, up to the • The bar graph illuminates up to the preset • Preset Mode: Vibration is Foot Pedal depressed preset level, are illuminated. level signifying that vacuum is present at the available immediately at its user •...
- Page 31 Lap Mode – Foot Pedal Functions Irrigation Aspiration Vibration Vibration • All of the display bars, up to the • The bar graph illuminates up to the preset • Preset Mode: Vibration is Foot Pedal depressed preset level, are illuminated. level signifying that vacuum is present at the available immediately at its user •...
-
Page 32: System Set-Up
6. System Set-up 6.1. Installation Upon delivery perform a visual inspection of the shipping container(s) and all system components for obvious shipping damages. If any damages are found, retain the shipping container and immediately notify the shipping carrier of any damages found. Care should be taken to stay within the recommended operating conditions (see Table 11.1... -
Page 33: Console Set-Up - Part I (In The Non-Sterile Field)
• System console with Wireless footswitch • IV Bag (500mL is recommended) • IV Administration Set, Macro Drip • Suction Canister (1200-2000 cc recommended) • Suction Tubing • Remote IR Receiver • Optional if COAG electrosurgery will be performed: 8 mm adapter and Umbilical Cable •... - Page 34 Method 1 - Handpiece assembled PRIOR to procedure in non-sterile field- Pre sterilization | Part I Remove Procedure Pack Lay components out on a clean area. components Assemble Handpiece Assemble as per instructions described in Sections Error! Reference source not found. and 7.3.
- Page 35 6.4.2 Method 2 – Handpiece assembly in the sterile field NOTE 6.4 The handpiece, torque wrench and torque fixture should be sterilized prior to starting assembly according to Method 2. WARNING 6.1 Use only sterilization cycles specified in this user manual. Do not use any other sterilization cycles. Improper sterilization can lead to handpiece or accessory damage, patient injury, or death.
-
Page 36: Console Set-Up - Part Ii (In The Non-Sterile Field)
Console Set-up – Part II (In the Non-Sterile Field) Console Set-up | Part II Hang IV bag/bottle Extend the IV pole and hook the IV bag/bottle on to it. Connect IV IV administration set should be connected to the last segment of the yellow striped irrigation tubing. Be sure to leave the Administration Set protective cap on the end of the IV spike. -
Page 37: Perform System Check
Table 6.5 Console set-up - Part II The SonaStar System is now ready for the system check NOTE 6.2 The IV pole should be positioned to yield continuous flow and visibility, but elevated IV bag position is not necessary to achieve flow. -
Page 38: Operative Use Of System
(see Figure, #2), plug the Remote IR receiver into its receptacle at the console rear and place it within direct line of sight with the footswitch. The Remote IR receiver can be moved closer to the wireless footswitch or linked directly to it to improve signal reception as needed. -
Page 39: Post-Operative Procedure
indicator. Remove the handpiece from the surgical site and refer to the troubleshooting chapter (Chapter 10, page 55) to diagnose and correct the fault or refer to the label on top of the console. To reset the system after correcting the fault, press either the Preset or Linear key. To prevent clogging of the aspiration lines, it is recommended periodically to briefly immerse the tip in sterile solution to clear the tubing. -
Page 40: Handpiece Assembly And Disassembly
7. Handpiece Assembly and Disassembly The SonaStar System can be used with two different handpieces (short straight or curved extended) along with a variety of tip configurations to perform different applications. The tip choice is determined by the type of target tissue. Please refer to Section 0 prior to handpiece assembly to determine which method of handpiece assembly will be used (Preassembly outside of the sterile field or complete assembly in the sterile field). -
Page 41: Handpiece Assembly - Curved Extended Handpiece (Ce)
7.3. Handpiece Assembly – Curved Extended Handpiece (CE) Perform an inspection of the handpiece and all components prior to assembly. Then prepare the procedure tray and necessary items that are provided with the unit. See Chapter Error! Reference source not found. for details on assembly o ptions (Preassembly outside of the sterile field or complete assembly in the sterile field). -
Page 42: Electrosurgery Connector Assembly
Install the silicone sleeve Install the silicone sleeve (from the procedure tray) onto the rigid housing tip assembly. 10. Attach the silicone tubing and o-ring Attach the smaller diameter tubing to the aspiration port on the front housing. Attach the larger diameter tubing to the blue connector on the rear of the handpiece. -
Page 43: Handpiece Disassembly - Short Straight Handpiece (Ss)
7.5. Handpiece Disassembly – Short Straight Handpiece (SS) Handpiece Disassembly – Short Straight (SS) Handpiece Remove the o-ring from the handpiece and disconnect the tubing from the handpiece connector and the aspiration port Remove the silicone/rigid sleeve from the front housing Remove the plastic front housing from the handpiece (front housing varies based upon tip selection) Remove the tip Place the handpiece into the torque fixture... - Page 44 Remove the o-ring from the handpiece and disconnect the tubing from the handpiece connector and the aspiration port Remove the silicone sleeve Remove the silicone sleeve from the rigid housing tip assembly. Remove the rigid housing tip assembly Pull the rigid housing tip assembly from the silicone elbow (do not discard). Disassemble housing tip assembly Unscrew the inner sleeve from the outer sleeve and separate from housing (do not discard).
-
Page 45: Monopolar Coag Guidelines
Console with Force 2 Electrosurgical Generator NOTE 8.1 The SonaStar system has been designed for use with monopolar COAG using a Misonix approved electrosurgical generator. CUT mode has NOT been approved for use with the SonaStar. DO NOT use this mode with the SonaStar. -
Page 46: Preparing The System For Monopolar Coag Use
1 Wireless Footswitch 2 Umbilical Cable 3 Electrosurgical Generator 4 Handpiece with Cable 5 Single-use Monopolar Handpiece Cable 6 Ground Pad w/ Cable 7 Ultrasonic Generator 8.2. Preparing the System for Monopolar COAG Use Consult the user manual supplied with the electrosurgery unit for operating instructions, safety guidelines, and setup. -
Page 47: Using Monopolar Coag With The Sonastar System
• Misonix recommends staying within the limits prescribed by the electrosurgical generator’s user manual for the type of procedure being performed, up to a maximum power setting of 70 W. Generally, the lowest setting that proves effective for the procedure being performed should be used. - Page 48 • During electrosurgery use, the tip may develop eschar buildup. To maximize efficiency, the tip should be wiped clean with a sterile pad and alcohol. Briefly activating vibration with the tip immersed in sterile saline will also clean the tip and flush the vacuum system lines. •...
-
Page 49: Cleaning, Sterilization And Maintenance
Failure to do so may lead to infections, which can ultimately cause patient death. WARNING 9.3 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 SonaStar 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 50 *Includes Rigid Front Sleeve found on Curved Extended Handpiece only. 9.2.1 Manual Cleaning Procedure Wrenches ® Wash items with hot water mixed with an enzymatic detergent such as ASP Enzol or Steris Wash & Brush ® Prolystica according to standard hospital protocol. Follow manufacturer’s directions for preparing solutions.
- Page 51 9.2.3 Cleaning of console, footswitch and IR receiver Misonix recommends the use of CaviWipes1™ or equivalent surface disinfectant wipes. Please follow the manufacturer’s instructions for surface cleaning and disinfection including without limitation, the use of Personal Protection Equipment (PPE) for bloodborne pathogens. Dispose of wipes with contaminated wastes.
-
Page 52: Sterilization Of Reusable Sterile Field Components
Please refer to Section 7.3 for more details. With Misonix Sterilization Tray 134-137°C 132°C (270°F) (274-279°F) Items placed in Misonix Sterilization Items placed in Misonix Sterilization Configuration Tray MXA-TRAY or MXA-TRAY-2 Tray MXA-TRAY or MXA-TRAY-2 Prevacuum... -
Page 53: Deviations From Decontamination, Cleaning And Sterilization Instructions
*Exposure time can be increased up to a maximum of 18 minutes to comply with local requirements and/or recommendations of the World Health Organization (WHO), Robert Koch Institute (RKI), etc. Misonix Inc reusable medical devices are able to sustain such sterilization cycles. -
Page 54: Moving The Unit
Should the user wish further information or instructions regarding any aspect of cleaning or sterilizing procedures, please contact Misonix Inc. or an Authorized Representative. 9.5. Moving the Unit Before moving the SonaStar within the hospital, please perform the following procedures: Disconnect all plugs and coil the power cord around the brackets at the rear of the unit. - Page 55 Reverse the above “Removal” procedure. The Torque Wrench (CFSM2-T018) should be returned to Misonix for recalibration every 12 months, regardless of use. Please contact Misonix for details. Refer to Chapter 12 for additional information on how to return products for repair/calibration.
-
Page 56: Troubleshooting
Possible Malfunctions, Not Associated with an Error Code Possible system symptoms, indicating a malfunction, that do not generate an error code are listed below. If the corrective action listed in the table does not solve the problem, contact your authorized Misonix, Inc. service representative. - Page 57 • Turn equipment in vicinity off to isolate other equipment from interfering with wireless signal. Table 10.1 Troubleshooting IFU-607 Rev D P age 56 of 65...
-
Page 58: Error Code Messages
Check irrigation tubing for proper loading into pump, jams, and kinks. Ensure pump is rotating. • Electronics Problem If error re-occurs contact your Misonix, Inc. service representative. E4 – Not Used E5 – Not Used E6 – Handpiece Connection Fault Handpiece not properly •... -
Page 59: Overriding Faults
CAUTION 10.1 Improper use or adjustment of this device may invalidate the Misonix, Inc. Warranty agreement. Contact your authorized Misonix, Inc. representative before attempting to troubleshoot this device in any manner other than those specified in this manual. -
Page 60: Specifications
11.Specifications Console Specifications • 100/110/115/120 VAC, 4 Amps, 50/60Hz Power input • 200/220/230/240 VAC, 2 Amps, 50Hz Must be configured to customer requirements during assembly at factory Operating frequency 23 kHz Ground leakage current 300 µA (max.) Setup mode: System setup Modes of Operation Standby mode: Irrigation &... - Page 61 Handpiece Specifications Short Straight Handpiece Operating frequency 23 kHz Maximum stroke amplitude Approximately 225 microns (with standard tip). Cable length 17’ | 5.2 m Dimensions 4.8” L (without probe) x 0.8” D | 13 cm x 2.0 cm Weight with tip 3.2 oz.
-
Page 62: Service, Repair And Technical Correspondence
The SonaStar is configured for a specific electrical input (line) at the factory before shipment, and is not intended to be configured or changed in the field except by Misonix authorized technical personnel. The unit may only be used with the electrical input originally intended. - Page 63 200/220/230/240 VAC Systems LITTLEFUSE Part Location on Rear of Fuse Fuse Fuse Rating Number Console Relevant Figure Type 5x20 mm 3.0A, 250V 0239003 Bottom Time Delay Figure 5.5 Console Lower (rear 5x20 mm 3.0A, 250V 0239003 Bottom Time Delay Figure 5.5 Console Lower (rear...
-
Page 64: Repair, Service And Replacement Parts
Always include a completed Declaration of Decontamination, prepay return shipping and specify method of shipment. CAUTION 12.2 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. CAUTION 12.3 When returning items, before using loose packing materials, such as foam pellets, shredded paper or similar, be sure to wrap the component(s) separately in plastic bags, film or other protective wrapping. - Page 65 Do not return any material for which such certification cannot be made without prior approval from Misonix, Inc. The correct return address should read as follows: MISONIX (Misonix, Inc.) Service Department RMA # ______________ 1938 New Highway Farmingdale, New York 11735 U.S.A.
- Page 66 +1.631.694.9555 Phone +1.631.694.3285 fax 1938 New Highway, Farmingdale, N.Y. 11735, U.S.A. MISONIX.COM │ NASDAQ SYMBOL. MSON IFU-607 Rev D P age 65 of 65...
Need help?
Do you have a question about the SonaStar SYSTEM-M300-0 Series and is the answer not in the manual?
Questions and answers