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Instructions for use, ERGO 300 - BOWA- IFU-12930- ERG0300-S0-EN-20210701 5

1.5

Medical application

This product is designed solely for use in medical facilities by medically qualified persons.

1.6

On receipt

•   The shipping package must contain all parts listed in chapter “1.6 Scope of delivery”.
•   If any parts are damaged or missing, contact the Nouvag agent from which the device was ordered or
  Nouvag AG.

Immediate inspection of the ERGO 300 - Morcellator - motor system set (REF 3287bow):

1. Control unit (905-001)

2. Power cable, country-specific

3. Gear unit (905-004)

4. Seal unit (5136bow)

5. 10 roof shaped seals (905-009)

6. 10 membrane seals for all cutting tube diameters

(905-512)

7. Electronic motor 21 (905-002)

8. 2 fuses (21606)

9. Vario pedal (905-003)

10. Threaded spray adapter (905-030) for NouvaOil

spray for the care of the electronic motor 21

11. Handle (905-005)

12. Printed IFU (12930)

Summary of Contents for ERGO 300

Page 1: ...EN ERGO 300 Morcellator Information for use 12930 S0 EN...

Page 2: ...2 Instructions for use ERGO 300 BOWA IFU 12930 ERG0300 S0 EN 20210701...

Page 3: ...t with protective tube according to option 1 15 5 3 2 Assembly of the Morcellator set with Trocar Cannula according to option 2 18 5 3 3 Mounting a grasping forceps according to option 3 21 5 4 Mains...

Page 4: ...ve that pre vents gas loss when withdrawing the instruments Option 3 Tissue removal myomectomy with myoma drill through the Trocar Cannula Insertion of the myoma drill through the Trocar Cannula 12 mm...

Page 5: ...missing contact the Nouvag agent from which the device was ordered or Nouvag AG Immediate inspection of the ERGO 300 Morcellator motor system set REF 3287bow 1 Control unit 905 001 2 Power cable count...

Page 6: ...seal 1 905 009 Set of 10 roof seals transparent for cutting tube 12 15 mm 10 905 512 Set of 10 membrane seals blue for cutting tube 12 15 20 mm 10 Accessories and spare parts according to option 2 51...

Page 7: ...Morcellator Maximum torque is delivered at the speed range of 200 400 rpm 1 9 Ambient conditions Transport and storage Operation Relative humidity 10 90 Max 80 Temperature 0 60 C 32 140 F 10 30 C 50...

Page 8: ...er to operating instructions Biohazard Pedal Disused electrical and electronic equipment is hazardous waste and must not be disposed of with household waste The local disposal regulations apply Potent...

Page 9: ...ristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this eq...

Page 10: ...her care products can lead to malfunctions and void the guarantee Uterine tissue may contain unsuspected cancerous tissue The use of laparoscopic motor driven morcellators in hysterectomy and myomecto...

Page 11: ...nection coupling 1 Key Vario variable speed range 2 Key Low low speed range 3 Key Medium medium speed range 4 Key High high speed range 5 Key changing rotation direction When changing the direction of...

Page 12: ...Grasping forceps 1 Protecting sleeve 2 Seal unit and Morcellator attachment 3 Valve actuation 4 Valve body 5 Main body 6 Nose for tissue protection 1 Cutting edge 2 Locking pins 1 Protection sleeve 2...

Page 13: ...Myoma drill Protection sleeve with 12 15 or 20 mm Protection sleeve with 12 or 15 mm Protection sleeve with 12 mm Obturator with 12 or 15 mm Obturator with 12 or 15 mm Cutting tube with 12 or 15 mm C...

Page 14: ...cket for the first time you must check the supply voltage setting next to the power switch In order to prevent the risk of electric shock the device may only be connected to a power network with a PE...

Page 15: ...nd undamaged e g no cracks deformation or burrs Use only cutting tubes in perfect condition 1 Inserting the cutting tube through the gear unit Remove the seal unit from the gear unit Insert the cuttin...

Page 16: ...he membrane seal 4 to point to the slot 5 of the membrane screw 6 and press the mem brane seal into the slot Screw the membrane screw 6 into the thread of the seal holder 3 to the stop and connect the...

Page 17: ...procedure 8 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...

Page 18: ...lure Problem the motor becomes very hot Cause the motor was damaged during preparation Remedy do not continue to use the motor Always have a spare motor available 5 3 2 Assembly of the Morcellator set...

Page 19: ...ushing the Trocar too far Push the Trocar Cannula over the distal end of the cutting tube The guide pin of the Trocar Cannula must be in the distal slot of the gear unit Lock the Trocar Cannula in pos...

Page 20: ...g into the bottom end of the handle Continue to insert the motor coupling until it locks into the gear unit motor connection Align the red dot on the device connection plug of the motor with the red d...

Page 21: ...continue to use the motor Always have a spare motor available 5 3 3 Mounting a grasping forceps according to option 3 Grasping forceps are available in various designs The gripper shown here is not s...

Page 22: ...es 6 1 Using the control unit Setting the speed The speed can be set manually in stages within a range of 50 to 1000 rpm Press to increase the speed Press to reduce the speed The set speed is shown on...

Page 23: ...r LED lights up The blade rotates at a speed within the range set by how far down the pedal is pressed To stop the motor remove foot from pedal Exit mode setting Press Changing direction of rotation T...

Page 24: ...lateral blood vessels kidneys and retroperitoneum Pull the tissue towards the rotating blade for morcellation with the gripper Risk of injury due to gas loss Gas may be lost during the procedure This...

Page 25: ...ctive tube in protected position NO CUT particularly if the cutting tube is not used for any period Insert and remove the protective tube and cutting tube under visual control endoscopy Risk of injury...

Page 26: ...PROTECTED is also shown on the black ring be tween the gear unit and protective tube 4 Inserting gripper Pull the Obturator out of the protective tube Close the proximal opening of the gear unit with...

Page 27: ...cutting tube with gear unit and seal unit into the proximal opening of the Trocar Cannula Cutting tube must be fully inserted Release the valve flap lever of the Trocar Cannula The guide pin of the T...

Page 28: ...e retracted mouth of the gripper must not touch the blade Repeat the process until the morcellated tissue has been completely removed Removing tissue without the use of the Gear Unit according to Opti...

Page 29: ...of Trocar Cannula and insert myoma drill 3 Uncovering myoma Remove tissue from the myoma with the myoma drill 4 Inserting the grasping forceps Insert grasping forceps through the second percuta neous...

Page 30: ...gear unit with the thumb to prevent gas loss Hold the Trocar Cannula and carefully disconnect gear unit with cutting tube from the Trocar Cannula and re move from patient The valve flap closes automat...

Page 31: ...assemble Trocar Cannula before decontamination Disassemble Trocar Cannula and rinse in deionized water during disassembly 1 Unscrew sealing cap holder from the proximal end of the Trocar Cannula 2 Rem...

Page 32: ...d of the cutting tube is very sharp handle the cutting tube very carefully Removing protective tube and cutting tube Make sure that the lock nut of the protective tube covers the distal end of the cut...

Page 33: ...t must be completely filled with cleaning solution and free from bubbles Do not use cleaning agents that contain solvents If sterilized accessories are not used immediately a sterilization indicator m...

Page 34: ...ing silicate formation on the instruments 4 Only commercially available DGHM VAH listed agents may be used for cleaning and disinfection The method of use exposure time and suitability of disinfecting...

Page 35: ...of damage The motor must not be placed in an ultrasonic bath or cleaned with compressed air The motor must not be placed in an ultrasonic bath or cleaned with compressed air Do not kink the motor cab...

Page 36: ...ction leaflet for the respective cleaning agent and disinfectant for dwell times Drying Machine drying The drying of the instruments and the attachments takes place through the drying cycle of the was...

Page 37: ...sed Information on validation of the Reprocessing The above reprocessing process has been verified by a validated procedure The following materials and machines were used 1 Alkaline cleanser Neodisher...

Page 38: ...51484nou PU 1 piece Seal cap holder 15 mm REF 51502nou PU 1 piece Maintenance small sealing unit with membrane fixing ring for cutting tubes 12 15 mm Replace damaged parts with new ones Sealing unit...

Page 39: ...e risk management deposited with the manufacturer The performance of safety inspections on medical devices is required by law in several countries The safety inspection is a regular safety check that...

Page 40: ...the treadplate 6 1 Using the control unit Motor is not connected Connect the motor cable to the control unit 5 2 1 Assembly of the Mor cellator set with protective tube option 1 5 2 2 Assembly of the...

Page 41: ...again The device detected undervoltage while the motor was running The pedal must be released for a short period Pedal was pressed while switching on the device The pedal must be released for a short...

Page 42: ...mm 1 per packaging unit 51502nou Seals for Trocar Cannula 12 mm and Trocar Cannula 15 mm PU 10 pieces 5177nou O ring for Trocar Cannula 12 mm and 15 mm PU 10 pieces 5180nou Replacement sealing unit s...

Page 43: ...Instructions for use ERGO 300 BOWA IFU 12930 ERG0300 S0 EN 20210701 43 Appendix...

Page 44: ...ssions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Product uses RF energy only for its internal function Therefore its RF emissions are very low and are not...

Page 45: ...0 MHz 80 AM bei 1 kHz d 0 35 P Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 80 AM bei 1 kHz 3 V m 80 MHz to 2 7 GHz 80 AM bei 1 kHz d 0 35 P 80 MHz to 800 MHz d 0 7 P 800 MHz to 2 7 GHz Where P i...

Page 46: ...in which radiated RF disturbances are controlled The customer or the user of the Product can help prevent electromagnet interference by maintaining a minimum distance between portable and mobile RF c...

Page 47: ...59 16 868 1507bow 905 003 Vario Fusspedal N A 36336 16 868 5163bow 905 004 Morcellator Getriebeeinheit mit Dichtungen N A 46729 17 949 5154bow 905 112 Morcellator Klinge Schneidrohr 12mm N A 46729 15...

Page 48: ......

Page 49: ...g address BOWA MEDICAL BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 72810 Gomaringen Deutschland Telefon 49 7072 6002 0 Telefax 49 7072 6002 33 E Mail service bowa medical com oder im Intern...

Page 50: ......

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Page 52: ...rasse 15 D 78462 Konstanz Phone 49 7531 1290 0 Fax 49 7531 1290 12 info de nouvag com Vertrieb durch BOWA MEDICAL BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 D 72810 Gomaringen Germany Phon...

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