Bowa ERGO 300 Instructions For Use Manual
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Bowa ERGO 300 Instructions For Use Manual

Morcellator
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Instructions for use
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ERGO 300 – Morcellator
13516EN-S0

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Summary of Contents for Bowa ERGO 300

  • Page 1 Instructions for use ERGO 300 – Morcellator 13516EN-S0...
  • Page 2 ERGO 300 – Morcellator Instructions for use...
  • Page 3 Instructions for use ERGO 300 – Morcellator General information Indications Principle Contraindications Target group Medical application On receipt Scope of delivery, accessories and spare parts Technical data ERGO 300 – Morcellator Ambient conditions 1.10 Warranty 1.11 Technical changes reserved Explanation of symbols Safety information EMC, Manufacturer’s Declaration of Conformity Modification and misuse...

  • Page 4: General Information

    ERGO 300 – Morcellator Instructions for use 1. General information Indications The Morcellator set is for the morcellation and extraction of tissue and for removing myomas or the uterus during laparoscopic procedures in gynecology. Principle For morcellation and extraction of tissue, as well as for removal of myomas or the uterus, during laparoscopic proce- dures, the ERGO 300 control unit is used in conjunction with the morcellator handpiece.
  • Page 5 ƒ The shipping package must contain all parts listed in chapter « 1.7 Scope of delivery, accessories and spare parts ». ƒ If parts are damaged or missing, contact BOWA  MEDICAL. Immediate control of the drive set « ERGO 300 – Morcellator » (REF 905-000): Control unit (REF 905-001)

  • Page 6: Scope Of Delivery, Accessories And Spare Parts

    Motor cable 2.9 m In line with regulations pertaining to hazardous materials, the lubricant spray (REF 905-032) are not delivered with the control unit but can be ordered separately: www.bowa-medical.com Please use the lubricating spray (REF 905-032) to maintain the micro motor and the gear unit.

  • Page 7: Ambient Conditions

    Instructions for use ERGO 300 – Morcellator Technical data ERGO 300 – Morcellator Voltage variable 100 V~/ 115 V~/ 230 V~, 50 / 60 Hz Fuses, power supply 2 fuses T 1 AL, 250 V AC Power consumption 60 VA Maximum motor speed 37,000 rpm Maximum motor torque 7,5 Ncm...

  • Page 8: Explanation Of Symbols

    ERGO 300 – Morcellator Instructions for use 2. Explanation of symbols Dangerous goods aerosol sprays: Warning Warning! Cleaning spray / Lubricant spray Dangerous goods aerosol spray: Dangerous goods aerosol sprays: Extremely flammable Environmentally hazardous Cleaning spray / Lubricant spray Cleaning spray / Lubricant spray Bio hazard Note on disposal Note...

  • Page 9: Safety Information

    The user or operator is solely responsible for any such use. Post market surveillance In the event of problems with the product or in the event of a serious incident, please immediately com- pile the following form https://www.bowa-medical.com/geraete-instrumenten-ruecksendung/ and send it as a pdf to the following email: service@bowa-medical.com...

  • Page 10: Essential Requirements

    ERGO 300 – Morcellator Instructions for use Essential requirements Before using the ERGO 300 – Morcellator, this The products described in this manual must instruction manual must be read thoroughly be used by trained and qualified medical per- and you must be well acquainted with the sonnel only in accordance with the require- functions and handling of the unit.

  • Page 11: Device Overview

    Instructions for use ERGO 300 – Morcellator 4. Device overview Front view Control panel Rear view Display Key «Vario» Mains connection (variable speed range) Motor LED Power switch ON/OFF Key «Low» Fuse compartment (low speed range) Pedal connection Window with indication of Key «Medium»...
  • Page 12 ERGO 300 – Morcellator Instructions for use Protection tube with obturator Protection sleeve Nose for tissue protection Ø 12 mm (REF 905-212) Obturator Ø 15 mm (REF 905-215) Ø 12 mm (REF 905-012) Connection cap attached to Ø 15 mm (REF 905-015) protection tube Cutting tube Cutting edge Cutting tube Ø...
  • Page 13 Instructions for use ERGO 300 – Morcellator System-Chart ERGO 300 – Morcellator Sealing unit Ø 12 / 15 mm Protection sleeve (REF 905-927) Ø 12 mm (REF 905-212) Ø 15 mm (REF 905-215) Obturator Gear unit Ø 12 mm (REF 905-012) (REF 905-004) Ø 15 mm (REF 905-015) Cutting tube Handle Ø...

  • Page 14: Before Use

    ERGO 300 – Morcellator Instructions for use 5. Before use The ERGO 300 – Morcellator and all required accessories and instruments must be placed on a level nonslip surface. Do not allow the operating range of the device with cable to be restricted by limiting factors. The display, keypad and indicator lights must be fully visible at all times.
  • Page 15 Instructions for use ERGO 300 – Morcellator Mounting the morcellator set with protective tube There is a risk of injury to tissue by the sharp edge at the distal end of the cutting tube. • Handle the cutting tube carefully. • If the cutting tube is not used, rotate the protective tube to the « NO CUT » position. •...
  • Page 16 ERGO 300 – Morcellator Instructions for use Protecting the cutting tube The distal end of the cutting tube is very sharp. To prevent injury, the cutting tube must be covered at all times when it is not in use. To cover the cutting tube, rotate the protective tube NO CUT until the words «...
  • Page 17 Instructions for use ERGO 300 – Morcellator Connecting the motor Insert the motor coupling into the bottom end of the handle. Continue to insert the motor until it locks into the gear unit’s motor connection. Align the red dot on the device connection plug of the motor with the red dot on the motor connection of the control unit.

  • Page 18: Operation

    ERGO 300 – Morcellator Instructions for use 6. Operation Prior to use Make sure that the product has been correctly prepared and inspected. Risk of injury The ERGO 300 – Morcellator - control unit has been designed for operation with the morcellation blades as a set.
  • Page 19 Instructions for use ERGO 300 – Morcellator Available speed modes ƒ « » (LOW, 100 – 400 rpm) ƒ « » (MEDIUM, 300 – 700 rpm) ƒ « » (HIGH, 500 – 1000 rpm) Activating mode setting ƒ Press « » to activate mode setting. The «MODE» LED lights up. The «LOW»...
  • Page 20 • BOWA  MEDICAL accepts no liability for any other applications. • BOWA  MEDICAL also recommends the use of a second gripper or a similar retaining device to prevent uncontrolled movement of large Morcellator pieces of tissue. This will require an additional percutane- ous access.
  • Page 21 Instructions for use ERGO 300 – Morcellator Risk of injury due to frictional heat! When using on patients, the user must urgently ensure that as little frictional heat as possible is gener- ated. High speeds and high contact pressure can lead to thermal necrotization of the tissue. Risk of injury! The distal end of the cutting tube is extremely sharp.
  • Page 22 ERGO 300 – Morcellator Instructions for use Morcellation with protection tube Hysterectomy Select the procedure for the hysterectomy in accordance with current medical standards. Inserting the cutting tube Make sure that the Obturator is inside the cutting tube. Make sure that the protection tube covers the blade of the cutting tube (set position to « NO CUT »; «...

  • Page 23: After Use

    Instructions for use ERGO 300 – Morcellator After use Switching off Switch the device off using the power switch at the back of the device (“O” position on the power switch). Removing the protection tube Rotate protection tube to the « NO CUT » position. Close the proximal opening of the gear unit with your thumb to prevent of gas loss.
  • Page 24 ERGO 300 – Morcellator Instructions for use Disassembly of the motor Disassembling of the motor (three steps) Disassemble the motor before decontamination. Unscrew handpiece holder from motor housing. Unscrew motor cap on cable from motor housing. Pull motor plug from motor. Disassembly of the gear unit and morcellator with protection tube Disassembling of the seal unit Remove membrane screw from the seal...

  • Page 25: Instrument Preparation

    • Perform cleaning, disinfection and sterilization after every treatment. • To autoclave single items, such as cutting tubes, BOWA  MEDICAL recommends the use of sterilization packages to prevent of damage.
  • Page 26 10. Under no circumstances should the instruments be cleaned in an ultrasonic bath! This leads to the impairment of functionality. 11. BOWA  MEDICAL recommends using a sieve basket with a rinsing bar from 3mach (REF 08-21-1), a reusable container for convenient preparation and storage (including transport) of the products. The sieve basket can be used for safe storage of the products both during the washing process and during and after sterilization until the products are used.
  • Page 27 Instructions for use ERGO 300 – Morcellator Pre-cleaning for 1. Wipe instruments with a damp disposable cloth, removing all visible contamination. cleaning and 2. Dismantle the instruments as far as possible according to Sections 6.2 to 6.4. disinfection 3. Brush off plastic parts and attachments under running tap water with a soft brush. 4.
  • Page 28 ERGO 300 – Morcellator Instructions for use Cleaning Machine cleaning Automatic cleaning process ( Vario-TD  program) 1. Instruments and attachments are placed in the sieve 1. Pre-clean for 4  minutes with cold water < 40°C. basket after pre-cleaning. 2. Empty 2. Connect the coupling housing of the gear unit to 3.
  • Page 29 Instructions for use ERGO 300 – Morcellator Sterilization The instruments are sterilized using a fractionated pre-vacuum steam sterilization process (in accordance with DIN EN 13060 or DIN EN 285 ), taking into account the respective national requirements. Minimum requirements: 1. Pre-vacuum phases: 3 2. Sterilization temperature: minimum 132°C to maximum 137°C 3.

  • Page 30: Maintenance And Repair

    ERGO 300 – Morcellator Instructions for use 8. Maintenance and repair General maintenance Motor cable ƒ Replace a damaged motor cable by a new one (REF 905-017) Protection tube ƒ Replace a damaged protective tube by a new one. Protection tube Ø 12 mm (REF 905-212) Protection tube Ø...

  • Page 31: Replacing The Control Unit Fuse

    Results shall be documented. The service instructions, circuit diagrams and descriptions are available on request from the manufacturer. BOWA  MEDICAL offers a safety inspection service for its customers. Addresses can be found in the appendix of this operation manual under „Technical service“.

  • Page 32: Malfunction And Troubleshooting

    ERGO 300 – Morcellator Instructions for use Malfunction and troubleshooting Malfunction Cause Solution Note Device is not operational Control unit is not switched Set the power switch « I/O » « 5.4 Mounting the morcella- (Display is not on) to « I ». tor set with protective tube »...

  • Page 33: Information On Disposal

    To order additional parts, please contact our customer service department. The user manual is available in printed form, included in the delivery of the ERGO-300 Morcellator set. If you prefer a PDF, you can request it at the following email: info@bowa-medical.com Information on disposal •...
  • Page 34 ERGO 300 – Morcellator Instructions for use Appendix...

  • Page 35: Electromagnetic Compatibility (Emc)

    Electromagnetic compatibility (EMC) Remark: The Product subsequently referred to herein always denotes the ERGO 300 (TCM 3000 BL Morcellator). Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the product and could cause EMC issues with this or other equipment. This product is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows.
  • Page 36 ERGO 300 – Morcellator Instructions for use variations on power If the user of the Product requires continued supply input lines 0 % U for 1 cycle 0 % U for 1 cycle operation during power mains interruptions, it is recommended that the Product be powered IEC 61000-4-11 70 % U ;...
  • Page 37 Instructions for use ERGO 300 – Morcellator Electromagnetic immunity against high-frequency wireless communication devices Test frequency Frequency Communication Modulation Maximum distance Test level band service Performance Pulse modulation 380 to 390 TETRA 400 18 Hz GMRS 460, 430 to 470 ± 5 kHz Hub FRS 460 1 kHz Sinus Pulse modulation...
  • Page 38 Nouvag AG BOWA  MEDICAL St. Gallerstrasse 25 BOWA electronic GmbH & Co. KG CH – 9403 Goldach Heinrich - Hertz - Strasse 4 – 10 Switzerland D – 72810 Gomaringen Germany Tel +41 71 846 66 00 Tel +49 7072-6002-0 info@nouvag.com Fax +49 7072-6002-33 www.nouvag.com...

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