Bowa ERGO 300 Operating Manual

OPERATING MANUAL
MORCELLATOR

MN009-938-S0 ERGO 300 3

Table of contents

1 General information 4

1.1 Indications 4

1.2 Principle 4

1.3 Contraindications 4

1.4 Medical application 4

1.5 On receipt 5

1.6 Scope of delivery, accessories and spare parts 6

1.7 Technical Data «ERGO 300 - Morcellator» 7

1.8 Ambient conditions 7

1.9 Warranty coverage 7

1.10 Right to make technical changes reserved 7

2 Explanation of symbols 8
3 Safety information 8

3.1 EMC Manufacturer’s Declaration of Conformity 8

3.2 Modification and misuse 8

3.3 Essential requirements 9

3.4 During use 9

4 Device overview 10

4.1 ERGO 300 Morcellator system chart 12

5 Before use 13

5.1 Connection to the power supply 13

5.2 Device preparation 13

5.2.1 Assembly of the Morcellator set with protective tube (option 1) 14

5.2.2 Assembly of the Morcellator set with Trocar Cannula (option 2) 17

5.3 Mains connection 19

6 Use 20

6.1 Using the control unit 20

6.2 Operation 22

6.2.1 Option 1: morcellation with protective tube 24

6.2.2 Option 2: morcellation with Trocar Cannula 25

6.2.3 Option 3: Myomectomy 27

6.3 After use 28

6.4 Disassembling Trocar Cannula 29

6.5 Disassembly of motor 30

6.6 Disassembly of gear unit and Morcellator with protective tube 30

7 Instrument preparation 31

7.1 Control unit and pedal 31

7.2 Preparation of the Trocar Cannula 32

7.3 Preparation of motor 33

7.4 Preparation of gear unit 35

7.5 Preparation of cutting tubes, protective tubes, filling rods, seals, seal unit and
myoma drill 36

8 Maintenance and repair 38

8.1 General maintenance 38

8.2 Replacing the control unit fuse 38

8.3 Safety inspections 39

8.4 Malfunction and troubleshooting 39

8.5 Spare parts list with order numbers 40

8.6 Information on disposal 40

9 Electromagnetic compatibility (EMC) 41

4 ERGO 300 MN009-938-S0

1 General information

1.1 Indications

Morcellator set for morcellation and extraction of tissue and for removing myomas or the uterus dur­ing laparoscopic procedures in surgery and gynaecology.

1.2 Principle

The ERGO 300 - Morcellator is a control unit for the BOWA Morcellator for use in morcellation and
extraction of tissue. A rotating cylindrical tube with a blade at the distal end is inserted through an
abdominal cavity that has been enlarged by an Insufflator. The tissue that is to be removed is guided
to the cutting tube by a gripper, cut off and removed through the tube.

This manual describes three different options for removing tissue by a laparoscopic procedure.

Option 1: Tissue removal by morcellation with protective tube.
Instruments (gripper) are inserted through a protective tube sealed by a valve system. The valve can
be covered by a thumb for removing the gripper from the sealed protective tube to prevent gas loss.

Option 2: Tissue removal by morcellation with Trocar Cannula.
Instruments (cutter tube, gripper) are inserted through the Trocar Cannula. The Trocar Cannula con­tains a valve that prevents gas loss when withdrawing the instruments.

Option 3: Tissue removal (myectomy) with myoma drill through the Trocar Cannula.
The myoma drill is inserted through the Morcellator (protective tube or Trocar Cannula). The Trocar
Cannula and the protective tube can be used with or without a cutting tube. No gas loss after re­moval of instruments with the Trocar Cannula, minimum gas loss during removal from the protective
tube, sealing unit
can be sealed with the thumb.

1.3 Contraindications

Do not use the Morcellator for the following:

• Treatment of malignant tumors

• Treatment of vascularized tissue

• Preparation of tissue

1.4 Medical application

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

MN009-938-S0 ERGO 300 5

1.5 On receipt

• The shipping package must contain all parts listed in 1.6 Scope of delivery.

• If any parts are damaged or missing, contact the BOWA agent from which the device was or-

dered or BOWA.

Immediate inspection of the ERGO 300 - Morcellator motor system (art. no. 905-000):

1. Morcellator control unit (905-001) including

2. power cord 3 m

3. Morcellator Gear unit complete including

4. Seals (905-004)

5. Cross seal (905-009) (10 pcs.)

6. Seals for Ø 12-22 mm instruments
(905-512) (10 pcs.)

7. Micromotor with cable 3 m (905-002)

8. Fuses (2 pcs.)

9. Vario Foot switch with cable 3 m (905-

003)

10. Morcellator Spray nozzle gear unit for Nou Clean
Spray (905-006)

11. Morcellator Spray nozzle motor for Nou
Clean Spray (905-007)

12. Handle (905-005)

13. Manual on CD-ROM

6 ERGO 300 MN009-938-S0

1.6 Scope of delivery, accessories and spare parts

Art.-no. Description Quantity

Basic Set

905-000 Morcellator ERGO 300 basic set comprising the following products ---------------------------- 1 unit

905-001 Morcellator Control unit ERGO 300 including power cord 3 m ----------------------------------- 1 unit
905-002 Morcellator Micromotor ERGO 300 with cable 3 m ------------------------------------------------- 1 unit
905-003 Morcellator Vario Foot switch with cable 3 m --------------------------------------------------------- 1 unit
905-004 Morcellator Gear unit complete including seals ------------------------------------------------------ 1 unit
905-005 Morcellator Handle ------------------------------------------------------------------------------------------ 1 unit
905-006 Morcellator Spray nozzle gear unit ---------------------------------------------------------------------- 1 unit
905-007 Morcellator Spray nozzle motor -------------------------------------------------------------------------- 1 unit
MN031-578 Manual on CD-ROM ---------------------------------------------------------------------------------------- 1 unit

Application-Sets

905-612 Morcellator application set Ø 12 mm ------------------------------------------------------------------- 1 unit
905-112 Morcellator Cutting tube Ø 12 mm ---------------------------------------------------------------------- 1 unit

905-212 Morcellator Protective sleeve Ø 12 mm ---------------------------------------------------------------- 1 unit
905-012 Obturator Ø 12 mm ----------------------------------------------------------------------------------------- 1 unit

905-615 Morcellator application set Ø 15 mm ------------------------------------------------------------------- 1 unit
905-115 Morcellator Cutting tube Ø 15 mm ---------------------------------------------------------------------- 1 unit

905-215 Morcellator Protective sleeve Ø 15 mm ---------------------------------------------------------------- 1 unit
905-015 Obturator Ø 15 mm ----------------------------------------------------------------------------------------- 1 unit

905-620 Morcellator application set Ø 20 mm ------------------------------------------------------------------- 1 unit
905-120 Morcellator Cutting tube Ø 20 mm ---------------------------------------------------------------------- 1 unit

905-220 Morcellator Protective sleeve Ø 20 mm ---------------------------------------------------------------- 1 unit
905-020 Obturator Ø 20 mm ----------------------------------------------------------------------------------------- 1 unit

Accessories and spare parts

905-312 Morcellator Trocar sleeve d12 mm ---------------------------------------------------------------------- 1 unit
905-315 Morcellator Trocar sleeve d15 mm ---------------------------------------------------------------------- 1 unit
905-008 Morcellator Carrier plate ERGO 300 -------------------------------------------------------------------- 1 unit
905-010 Morcellator Myoma drill d10 mm ------------------------------------------------------------------------- 1 unit
905-011 Morcellator Gasket holder ---------------------------------------------------------------------------- per 1 unit
905-009 Morcellator Cross seal ------------------------------------------------------------------------------------ 10 unit
905-512 Morcellator Seal d12-20 mm 12-20 mm--------------------------------------------------------------- 10 unit
905-013 Morcellator Motor cable 3 m ------------------------------------------------------------------------------ 1 unit

In line with regulations pertaining to hazardous materials, the following items are not deliv­ered with the control unit but can be ordered separately from any official BOWA service cen­tre. www.bowa.de

905-014 Morcellator Cleaning spray "Nou Clean" -------------------------------------------------------------------- 1 unit

MN009-938-S0 ERGO 300 7

1.7 Technical Data «ERGO 300 - Morcellator»

Voltage -------------------------------------------------------------- variable: 100 V∼/ 115 V∼/ 230 V∼, 50–60 Hz
Fuse, power supply ------------------------------------------------------------------------- 2 fuses T 1 AL 250 V AC
Power consumption ------------------------------------------------------------------------------------------------- 60 VA
Maximum motor speed -------------------------------------------------------------------------------------- 40,000 rpm
Maximum torque, motor ------------------------------------------------------------------------------------------- 6 Ncm
Torque at gear output -------------------------------------------------------------------------------------------- 80 Ncm
Motor coupling ------------------------------------------------------------------------------ INTRA coupling ISO3964
Motor cable length ------------------------------------------------------------------------------------------------------ 3 m
Pedal cable length ------------------------------------------------------------------------------------------------------ 3 m
Morcellator speed ----------------------------------------------------------------------------------------- 50 – 1000 rpm
Protection class ------------------------------------------------------------------------------------------------------class II
Applied part type ------------------------------------------------------------------------------------------------- Typ BF *
Foot switch -------------------------------------------------------------------------------------------------------------- IPX8
Dimensions (W x D x H) ------------------------------------------------------------------------ 120 x 180 x 107 mm
Net weight control unit ---------------------------------------------------------------------------------------------- 1,8 kg

* Applied part is the Morcellator

1.8 Ambient conditions

Transport and storage:

Operation:

Relative humidity:

Max. 90 %

Max. 80 %

Temperature:

10°C to 60°C

10°C to 30°C

Atmospheric pressure:

700 hPa to 1060 hPa

800 hPa to 1060 hPa

1.9 Warranty coverage

Purchasing the ERGO 300 - Morcellator entitles you to a 1-year warranty. If you return the warranty

card for registration within four weeks of the date of purchase, warranty coverage will be extended
for a further 6 months. Improper use or repair, or failure to observe these instructions, will relieve us
from any obligation arising from warranty provisions or other claims.

1.10 Right to make technical changes reserved

Illustrations, dimensions and weights and technical data may vary slightly as a result of continuing
development. We reserve the right to make changes and we are not responsible for printing errors.

8 ERGO 300 MN009-938-S0

2 Explanation of symbols

3 Safety information

Your safety, the safety of your team and of course that of your patients is very important to us. It is therefore
essential to bear the following information in mind:

3.1 EMC Manufacturer’s Declaration of Conformity

Please observe the information on electromagnetic compatibility provided with these operating instructions.

3.2 Modification and misuse

Important information

Autoclavable at 135°C

Warning

Suitable for thermal disinfection

Manufacturer

Protection against continuous submersion
in

Applied part of type BF is the Morcella­tor

Protection class II

Certified by the Canadian Standards
Association (CSA)

Electrical and electronic devices that have
reached the end of their service life com­prise hazardous waste and may not be
disposed of together with household waste.
Local disposal regulations apply.

CE mark with Notified Body

Symbol indicating the order number

Intermittent operation, 1 min on, 1 min
off

Symbol indicating the serial number with
the

Observe the instructions for use

Motor

Pedal

Biohazard

• Modification or manipulation of the ERGO 300 - Morcellator and its accessories is prohibited.
The manufacturer is not liable for any damages resulting from unauthorized modifications or

manipulations. The warranty will be cancelled.

• Use of the ERGO 300 - Morcellator outside the indications described in Section 1.1 is
prohibited.

The user or operator is solely responsible for any such use.

MN009-938-S0 ERGO 300 9

3.3 Essential requirements

Before use read this manual and the
manuals for all other equipment used
in the procedure thoroughly.

The products described in this manual must be
used by trained and qualified medical personnel
only in accordance with the requirements and
with reference to the manual.

For protection of the patient, the user
and third parties the products used
must be prepared as specified in the
manual.

Improper use or repair of the device, or failure to
observe these instructions, will relieve us from
any obligation arising from warranty provisions or
other claims.

The use of third-party products is the
responsibility of the operator.
Functionality and patient safety cannot
be guaranteed with third-party acces­sories.

Prior to using the device, before startup, and
before operation, the user must always ensure
that the device and accessories are in good
working order and are clean, sterile and opera­tional.

Repairs may only be performed by
authorized BOWA service technicians.

Use Nou-Clean spray to care for the motor and
gear unit. Using other care products can result in
malfunctions and/or cause the warranty to be
revoked.

3.4 During use

The device is not sterile on delivery. All
sterilizable parts must be sterilized
before use (see Chapter 7 Instrument
preparation).

Never operate the clamping mechanisms of the
cutting tubes while the system is running. This
could result in instrument damage.

Operate the device only outside the
danger zone of explosive, flammable
mixtures or gases.

Keep hands clear of the cutting tubes when op­erating the device. Danger of serious injury.

The motor ventilation slots must be
kept clear in order to prevent the motor
from overheating.

The ERGO 300 - Morcellator must be operated
under the continuous supervision of medically
qualified persons only.

Disregarding the guidelines on intermit­tent operation (1 min on, 1 min off for 8
cycles) may cause burns at contact
with the gear unit.

Make sure that the operating voltage to the
mains voltage.

10 ERGO 300 MN009-938-S0

4 Device overview

Front view Control panel Rear view

Rear view Handle Motor

1. Display

2. Motor LED

3. Pedal connection

4. Motor connection

1. Mode button (variable speed range)

2. Low button (low speed range)

3. Medium button (medium speed

range)

4. High button (high speed range)

5. Change rotational direction button

6. Up button (increase value)

7. Down button (reduce value)

1. Flange for protective tube con­nect

2. Thread for seal holder

3. Cutting tube holder

4. Seal holder

5. Thread for membrane screw

6. Membrane screw

7. Seal holder thread

8. Motor connection coupling

1. Release lever

2. Slots for motor ventila­tion

1. Mains connection

2. Power switch

3. Fuse module

4. Window with national

voltage display

5. Type plate with type

designation, reference

number, serial number,
information on power
supply and device fuse

1. Device connection plug

2. Motor cable

3. Motor cap

4. Motor

5. Handpiece holder

6. Motor connection

plug

MN009-938-S0 ERGO 300 11

Protective tube with filling rod

Cutting tube

Trocar Cannula

1. Protective tube

2. Lock nut

3. Tissue positioner

4. Filling rod

1. Protective tube

2. Seal cap holder

3. Valve actuator

6. Unterer Schenkel

7. Feder

8. Flexibler Arm der

Raste

4. Valve body

5. Main body

6. Nose

1. Cutting edge

2. Locking pins

6

12 ERGO 300 MN009-938-S0

4.1 ERGO 300 Morcellator system chart

MN009-938-S0 ERGO 300 13

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.
It is very important to ensure that no objects can fall on the pedal.
The power plug at the rear of the device must be accessible at all times.

5.1 Connection to the power supply

• Before plugging the power cable into the power socket 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

If the voltage shown does not correspond to the local mains voltage, the grey fuse holder must be set
to the correct voltage:

1. Swich the device off.

2. Unplug the power cable.

3. Use a screwdriver to open the fuse slot.

4. Remove the fuse holder.

5. Remove the grey fuse holder and reinsert it so that the local mains voltage set-

ting is shown in the small window.

6. Slide the grey fuse holder back in and close the fuse slot.

7. Check the mains voltage shown on the fuse slot.

8. Plug the power cable back into the device.

5.2 Device preparation

The device is not sterile on delivery. All sterilizable parts must be sterilized before use
(see Chapter 7 Instrument preparation).

If the accessories have already been sterilized: when removing them from the sterile packaging,
ensure that the sterile packaging is not damaged and that the sterility indicator confirms sterility
and shelf life of the sterile item has not expired.

The Morcellator (as per option 1 to option 3) must be assembled under sterile conditions (wear
gloves and a mask, place Morcellator and accessories on a sterile surface).

14 ERGO 300 MN009-938-S0

5.2.1 Assembly of the Morcellator set with protective tube (option 1)

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.

• If the cutting tube is not used, it must be placed on a flat, sterile surface so it cannot fall and

cause injury

• Check the cutting tube.

• Make sure that the cutting edge of the blade is sharp and undamaged (e.g. no cracks, defor-

mation 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 cutting tube through the gear unit. The two guide
pins on the cutting tube must fit into the slot on the flange
of the gear unit.

2. Fixing the cutting tube to the gear unit

Hold the cutting tube with one hand.
Connect the sealing unit to the gear unit with the
bayone closure with the other hand.

3. Mounting protective tube

Select a suitable protective tube.
Push the protective tube over the distal end of

the cutting tube. The guide pin of the protective
tube must be in the distal slot of the gear unit.

Lock the protective tube in position with a click.

4. 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
until the words “NO CUT” are visible in the distal slot of
the gear unit.
The cutting tube is completely covered by the protective
tube.

MN009-938-S0 ERGO 300 15

5. Replacing seals

Remove the seal unit from the gear unit by rotating it
slightly. Unscrew the membrane screw from the seal
unit.

Check seals before use. Do not use dam­aged seals (frayed, discolored, yellowed,
porous, non-elastic).

Position the edge of the cross seal (1) to point
to the inside stop (2) of the seal holder (3) and
press the cross seal in.

Position the edge of the membrane seal (4) to
point to the slot (5) of the membrane screw (6)
and press the membrane seal into the slot.

Screw the membrane screw (6) into the thread
of the seal holder (3) to the stop and connect
the seal unit to the gear unit.

6. Inserting filling rod

Insert the filling rod through the seal unit, gear unit and
protective tube to the stop.

7. Attaching handle

Lift and hold the release lever (1) of the handle (2).
Push the handle (2) over the motor connection of the gear

unit.
Release the handle release lever. The handle release lever

must lock in position.

Do not open the handle release lever to remove the handle during the procedure..

8. Connecting motor

Insert the motor coupling into the
bottom end of the handle.

Continue to insert the motor coupling until it locks into
the gear unit motor connection.

16 ERGO 300 MN009-938-S0

Align the red dot on the device connection plug of the
motor with the red dot on the motor connection of the
control unit.

Plug the motor device connection plug into the motor
connection of the control unit. The plug must lock in
position.

9. Connecting pedal

Align the red dot on the device connection plug of the
pedal with the red dot on the pedal connection of the
control unit.

Plug the pedal device connection plug into the pedal
connection of the control unit.

The plug must lock in position.

10. Functional check

• Check Morcellator for loose parts

• Check that Morcellator is correctly assembled

• Are all labels easily readable?

• Check cutting tube: cutting tube evenly ground, no broken edges or bends?

• Switch on control unit

• Switch on motor (press foot switch).

• Run motor with Morcellator for about 20 seconds; it must reach the set speed.

• If it does not run evenly, switch off motor with Morcellator..

• Switch off control unit.

The control unit will only operate if the foot switch has been connected to the control unit.

• Check that Morcellator is correctly assembled.

• Check that the gear unit runs smoothly; if necessary treat it with Nou-Clean care spray.

• Check that the motor is clean and runs smoothly; if necessary clean it and treat with Nou-Clean care

spray.

• Repeat the function check.

Risk of injury by motor failure

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.

MN009-938-S0 ERGO 300 17

5.2.2 Assembly of the Morcellator set with Trocar Cannula (option 2)

Using the Trocar Cannula
The Trocar Cannula is used instead of the protective tube. The integrated valve flap prevents the
escape of gas when instruments are moved in and out.
The nose of the Trocar Cannula partially extends beyond the cutter tube to protect organs in the
abdominal cavity from the sharp blade. This requires the Morcellator to be rotated under visual
supervision (endoscopy) so the nose of the Trocar Cannula covers the cutter tube blade to protect
the organ.

1. Visual check

• Check the product for sealing, corrosion and sterility.

• Ensure that it is free from rust, dents and scratches.

• The distal end of the filling rod must not be damaged.

• The sealing flap and the seal must not be damaged.

Risk of injury

Select blade. Make sure that the cutting edge of the blade is sharp and undamaged (e.g. no cracks or
burrs).

2. Insert the cutting tube through the gear unit

Remove the seal unit from the gear unit.

Insert the cutting tube through the gear unit. The two guide
pins on the cutting tube must fit into the slot on the flange of
the gear unit.

3. Fixing the cutting tube to the gear unit

Hold the cutting tube with one hand.
Connect the seal unit to the gear unit with the bayonet closure

with the other hand.

4. Mounting Trocar Cannula

Select a suitable Trocar Cannula. Open the Trocar
Cannula valve by actuating the lever to prevent damage to
the cutting tube by pushing 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 position with a click.

18 ERGO 300 MN009-938-S0

5. Replacing seals

Remove the seal unit from the gear unit by rotat­ing it slightly.

Unscrew the membrane screw from the seal unit.

Position the edge of the cross seal (1)
to point to the inside contact (2) of the seal holder (3)
and press the cross seal in.
Position the edge of the membrane seal (4) to point
to the slot (5) of the membrane screw (6) and press
the membrane seal into the slot.

Screw the membrane screw (6) into the thread of the
seal holder (3) to the stop and connect the seal unit
to the gear unit.

6. Inserting filling rod

Insert the filling rod through the seal unit,
gear unit and Trocar Cannula.

7. Attaching handle

Lift and hold the release lever (1) of the handle (2).

Push the handle (2) over the motor connection of the
gear unit.

Release the handle release lever. The handle release
lever must lock in position.

8. Connecting motor
Insert the motor coupling into the bottom end of the

handle.
Continue to insert the motor coupling until it locks in-

to the gear unit 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.

Plug the motor device connection plug into the motor connection of the control unit.
The plug must lock in position.

9. Connecting pedal

Align the red dot on the device connection plug of the
pedal with the red dot on the pedal connection of the
control unit.

Plug the pedal device connection plug into the pedal
connection of the control unit. The plug must lock in
position.

MN009-938-S0 ERGO 300 19

Functional check

• Check Morcellator for loose parts

• Check that Morcellator is correctly assembled

• Are all labels easily readable?

• Check cutting tube: cutting tube evenly ground, no broken edges or bends?

• Switch on control unit

• Switch on motor (press foot switch).

• Run motor with Morcellator for about 20 seconds; it must reach the set speed.

• If it does not run evenly, switch off motor with Morcellator.

• Switch off control unit.

The control unit will only operate if the foot switch has been connected to the control unit.

• Check that Morcellator is correctly assembled.

• Check that the gear unit runs smoothly; if necessary treat it with Nou-Clean care spray.

• Check that the motor is clean and runs smoothly; if necessary clean it and treat with Nou-Clean

care spray.

• Repeat the function check.

5.3 Mains connection

Risk of electric shock

Connect the device to an earthed AC mains system that conforms to IEC guidelines only. Connect
the device to a power supply that corresponds to the connection values on the type plate on the
back of the device.

Risk of damage

Do not switch on the control unit and the other equipment until all cables have been connected.
Otherwise the equipment may be damaged.

The device is not water-proof.

Keep the device away from liquids. Keep the mains connection socket dry. Do not use the device
if liquid penetrates it.

Connecting the power cable

Switch off the power switch on the back of the device (“O” position).
Plug the included power cable into the socket on the back of the device.
Plug the other end of the power cable into the power socket.

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.

20 ERGO 300 MN009-938-S0

6 Use

Before 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. The user is solely responsible if different products are used with the set. Incom­patibility may risk injury to patients.

Switching on and off

Switch on the control unit. The display lights up. A short signal tone sounds. The control unit dis­plays the value “200 rpm”.

Operating mode (motor)

The motor is designed for intermittent operation (1 minute on, 1 minute off for 8 cycles).

6.1 Using the control unit

Setting the speed

The speed can be set manually in stages (within a
range of 50 to 100 rpm).

Press « » to increase the speed.

Press « » to reduce the speed.

The set speed is shown on the display.

Starting motor

Press foot switch.
The blade rotates at the set speed.
The motor LED lights up.
To stop the motor remove foot from foot switch.

Risk of injury and damage due to heat!

The Morcellator may generate heat if operated for a long period.

Remedy:
Use Morcellator only in intermittent mode of “1 minute on, 1 minute off for 8 cycles”.
Stop the Morcellator immediately if one or more components of the Morcellator set become very
warm.

Precaution when changing parameters. Unusual behaviour of instruments while operating may
provoke false reactions and jeopardize the patient.
Every setting and the new behaviour of the instrument has to be verified and tested.

MN009-938-S0 ERGO 300 21

Available rotary modes

« » (100 – 400 rpm)

« » (300 – 700 rpm)

« » (500 – 1000 rpm)

Activating mode setting

Press « » to activate mode setting.
The Mode LED lights up.
The Low LED lights up. (Default setting)
The display shows “VARIO LOW, 100 – 400 rpm”.

Selecting mode

Press « », « » or « » to select the
corresponding mode.

The display shows the mode and the corresponding
speed range that can be selected with the pedal.

The corresponding LED lights up.

Starting motor

Press foot switch. The motor LED lights. The
blade rotates at a speed within the range set by how far down the
foot switch is pressed.

To stop the motor remove foot from pedal.

Exit mode setting

Press « »

Changing direction of rotation

To change the direction of rotation, press« »

The display shows the mode and the corresponding
speed range that can be selected with the pedal.

The corresponding LED lights up.

22 ERGO 300 MN009-938-S0

6.2 Operation

Risk of death or serious injury!

Unsupervised cutting may injure the abdominal wall and organs and cause the death of the pa­tient.

Remedy:

• Before every procedure make sure that an endoscopic procedure is preferable to a conven­tional procedure.

• Use only the products described in this manual.

• During the procedure use the protective tube or Trocar Cannula as a precautionary measure.
Follow “Option 1: Morcellation with protective tube” and “Option 2: Morcellation with Trocar
Cannula” in Chapter 5.

• Use Morcellator under visual control (endoscope) only.

• Use Morcellator only for morcellation of tissue that has been fully prepared and is clearly visi-

ble. BOWA accepts no liability for any other applications.

• BOWA 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
percutaneous access.

• Fix the Morcellator in a ventrolateral position to prevent movements inside the uterus.

• Prevent movement of the 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 may result in the abdominal wall dropping.

• Select an Insufflator with adequate flow to prevent the abdominal wall from dropping.

• Use the Morcellator with protective tube as in option 1: when removing or replacing instruments,

immediately close the proximal opening of the seal unit with the thumbs.

• Use with Trocar Cannula as in option 2: pull the Morcellator with cutting tube out of the Trocar
Cannula.
The Trocar Cannula valve closes to prevent gas loss..

• After removal of the morcellated tissue, insert the Morcellator into the Trocar Cannula and repeat
the process.

Risk of injury!

The Morcellator system is designed for removing tissue with the greatest possible safety. For this
purpose the protective tube and the Trocar Cannula are both fitted with a valve flap.

Morcellation without protective tube or Trocar Cannula is prohibited.

Tissue escapes the gripper.

Tissue may escape the gripper during the procedure and fall into the abdominal cavity.

Causes:

• The tissue is not gripped tightly enough.

Remedy:

• Grip the tissue at a different position

• Press the jaws of the gripper together as tightly as possible.

MN009-938-S0 ERGO 300 23

Risk of injury due to heat generated by friction!

The user must ensure that as little friction heat as possible is generated during a procedure on a
patient.

High speeds and high application pressure may cause thermal necrosis of tissue.

Risk of injury!

The distal end of the cutting tube is extremely sharp.
Precautions:

• Handle the cutting tube particularly cautiously and carefully.

• Where possible, have the Morcellator with protective tube in protected position (NO CUT), par-

ticularly 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!

When inserting the filling rod through the percutaneous access, there is risk of injury to blood
vessels, intestinal loops or the bladder. This can result in significant complications, which will
require a Laparotomy.

Risk of damage to the blade of the cutting tube!

If the jaws of the gripper are not completely closed when it is pulled from the protective tube, the
blade will be damaged (see pictures).

Risk of injury!

Damaged blades and cutting tubes must not be used.
Cutting tubes must not be sharpened.

24 ERGO 300 MN009-938-S0

6.2.1 Option 1: morcellation with protective tube

1. Hysterektomie

Select the procedure for the hysterectomy in accordance with current medical standards.

2. Inserting cutting tube

Make sure that the filling rod is inside the cutting tube.
Make sure that the protective tube covers the blade on the cutting tube (set position to NO CUT;

“PROTECTED” is also shown on the black ring between the gear unit and protective tube).
Insert Morcellator (with filling rod) into an existing percutaneous access under visual control (endos-

copy).

3. Using cutting tube

To use the cutting tube, rotate the protective
tube to uncover the blade of the cutting tube
(unprotected CUT position is displayed).

To cover the blade again, rotate the protective
tube (protected NO CUT position is displayed;
“PROTECTED” is also shown on the black
ring between the gear unit and protective
tube).

4. Inserting gripper

Pull the filling rod out of the protective tube.
Close the proximal opening of the gear unit

with the thumbs immediately.
Insert gripper carefully through the proximal

opening of the gear unit.

5. Removing tissue

Grip the tissue with the gripper under
good visual control (endoscopy).

The handle lock is set
Start the motor of the Morcellator set.
Pull the tissue towards the rotating

blade for morcellation with the gripper.
As the cut progresses pull the gripper
with the tissue further out of the Morcel­lator.

Carefully pull the complete gripper with
the separated tissue out of the Morcel­lator and the patient. The retracted
mouth must not touch the blade of the
cutting tube.

Repeat the process until the tissue has been
completely removed.

Make sure that the proximal opening of the seal unit is closed immediately with the thumb when
there is no instrument in the Morcellator to prevent large quantities of gas from escaping.

Endoscope

MN009-938-S0 ERGO 300 25

6.2.2 Option 2: morcellation with Trocar Cannula

1. Hysterectomy

Select the procedure for the hysterectomy in
accordance with current medical standards.

2. Inserting Trocar Cannula

Insert Trocar Cannula with filling rod into an
existing access under visual control (endos­copy).

Remove Trocar mandrel.

3. Insert the cutting tube through the Trocar
Cannula

Actuate the valve flap lever of the Trocar
Cannula and hold in this position..

Carefully insert prepared 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 Trocar Cannula must be

in the distal slot of the gear unit.
Lock the Trocar Cannula in position with a

click.
Make sure that the cutting tube remains in the

NO CUT position.

4. Inserting gripper

Insert gripper carefully through the proximal
opening of the gear unit and Trocar Cannula.

5. Preparing cutting tube

Rotate the Trocar Cannula so the CUT posi­tion is visible from above.

If the cutting tube is completely inserted, the
cutting edge is now only partially covered by
the Trocar Cannula.

CUT

26 ERGO 300 MN009-938-S0

6. Protecting tissue

The nose on the Trocar Cannula, which par­tially covers the sharp edge of the blade, must
protect tissue that should not be injured.

Rotate the Morcellator to the desired position
for this.

7. Removing tissue

Grip the required tissue with the gripper.
The handle lock is set
Start the Morecellator set motor
Pull the tissue towards the rotating blade

with the gripper.
Pull the gripper out of the patient through

the gear unit. The retracted mouth of the
gripper must not touch the blade.

Repeat the process until the Morcellator
tissue has been completely removed.

Protected area

Unprotected
cutting area

MN009-938-S0 ERGO 300 27

6.2.3 Option 3: Myomectomy

The myoma drill has been designed exclusively for removing tissue from a myoma.

1. Inserting Morcellator

Insert Morcellator with protective tube through
the percutaneous access.

Keep gripper ready to remove the tissue from
the myoma drill.

2. Inserting myoma drill

Insert Trocar Cannula through an additional
percutaneous access.

Open valve flap of Trocar Cannula and insert
myoma drill.

3. Upcoming myoma

Remove tissue from the myoma with the myoma
drill

4. Inserting gripper

Insert gripper through the second access and
remove separated tissue from the myoma
drill.

Remove myoma drill.

5. Removing separated tissue

If the piece of tissue is larger than the diameter of the cutting tube, start the Morcellator set motor.
Pull the tissue towards the rotating blade with the gripper.
(Smaller pieces of tissue can be removed without morcellation)
Carefully pull the complete gripper out of the Morcellator and the patient. The retracted mouth must

not touch the blade of the cutting tube.

6. Removing additional tissue

If necessary, re-insert the myoma drill and repeat the above process.

28 ERGO 300 MN009-938-S0

6.3 After use

1. Switching off

Switch off the power switch on the back of the device (“O” position).

2. Removing protective tube (when using Morcellator with protective tube)

Rotate protective tube to NO CUT position.
Close the proximal opening of the gear unit with the thumb to prevent gas loss.
Hold the protective tube and carefully disconnect gear unit with cutting tube and remove from pa-

tient.
The protective tube can also be removed from the percutaneous access.
If applicable, remove any other instruments.

3. Removing the cutting tube (when using the Morcellator with Trocar Cannula)

Close the proximal opening of the gear unit with the thumb to prevent gas loss.
Hold the Trocar Cannula and carefully disconnect gear unit with cutting tube from the Trocar Cannu-

la and remove from patient. The valve flap closes automatically as soon as the cutting tube is pulled
out.

The Trocar Cannula can remain as access throughout the remaining procedure.

4. Disconnecting gear unit connections

Pull the motor coupling from the gear unit mo­tor connection.

Pull the motor device connection plug from
the motor connection of the control unit.

Pull the motor out of the handle.
Lift and hold the release lever of the handle.
Pull the handle from the gear unit motor

connection.

5. Disconnecting pedal connections

Pull the pedal device connection plug from the
pedal connection of the control unit.

6. Preparing for preparation at the location of use

Take the product to the preparation area imme­diately.
Prepare the product as specified in this manual.

MN009-938-S0 ERGO 300 29

6.4 Disassembling Trocar Cannula

Disassembling Trocar Cannula (four steps)

Disassemble 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. Remove the internal seal from the seal­ing cap holder.

3. Unscrew the valve body from the main
body.

4. Remove the red O-ring from the valve
body.

30 ERGO 300 MN009-938-S0

6.5 Disassembly of motor

Disassembling motor (three steps)

Disassemble motor before decontamination.

1. Unscrew handpiece holder from motor

2. Unscrew motor cap from motor

3. Pull motor plug from motor.

6.6 Disassembly of gear unit and Morcellator with protective tube

Disassembling seal unit

Remove membrane screw from seal unit and
remove membrane seal.

Remove seal retainer from gear unit and
remove cross seal.

Risk of injury for the user!

The distal end 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 cutting tube
(protected NO CUT position is visible).

Hold the gear unit with one hand so the distal
end of the cutting tube does not point to the
user or any other person.

With the other hand carefully disconnect the
protective tube from the gear unit and pull it
off.

Hold the cutting tube with the same hand and
press it lightly against the gear unit until it re­leases itself from the holder and slides out
smoothly. It can now be pulled out of the
proximal opening of the gear unit.

1.Remove
protective tube Schutzrohr abziehen

2. Pull out
cutting tube Schneidrohr herausziehen

MN009-938-S0 ERGO 300 31

7 Instrument preparation

• Do not clean Morcellator with compressed air.

• Use only cleaning and care spray recommended by BOWA – other care sprays may destroy

the Morcellator.

• At unpacked steam sterilization of single items it must be regarded that they have a stable
seat in the tray to prevent them from rolling around, causing damage.

• Allow the Morcellator to cool down after steam sterilization!

Immersing instruments in cleaning solution

• Never exceed the maximum concentration and exposure time specified by the manufacturer
of the cleaning and disinfection solution.

• Air bubbles must not adhere to the instrument.

• All components of the instrument must be completely immersed in the cleaning solution.

• All lumina of the instrument 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 must be placed on the

packaging and it must be labelled with the sterilization date.

• Perform cleaning, disinfection and sterilization after every treatment.

• To autoclave single items, such as cutting tubes, BOWA recommends the use of sterilization

packages to prevent of damage.

• Make sure that sterilization packaging is no more than 80 % full.

• Autoclave material for at least five minutes at 135 °C.

• If sterilized material is not used immediately, the sterilization packaging must be labelled with

the sterilization date.

• BOWA recommends including a sterility indicator.

7.1 Control unit and pedal

The control unit and pedal do not come into contact with the patient.
Wipe the outside using microbiologically tested surface disinfectant or a 70 % -isopropyl alcohol solution.
The front plate of the control unit is sealed accordingly for this purpose and can be wiped clean.

Risk of damage!

Do not use incompatible preparation methods. The product may be damaged.

Risk of damage to the ERGO 300 - Morcellator control unit!

• Wipe away dirt or dust with a soft cloth.

• Use a moist cloth for stubborn dirt.

Risk of infection!

Prepare the product before its first use and before every subsequent use as specified in this
manual. Inadequate and/or incomplete preparation of the product may cause an infection of the
patient. Observe the following specific instructions.

32 ERGO 300 MN009-938-S0

7.2 Preparation of the Trocar Cannula

Essential requirements

Avoid long wait times until preparation due to risk of drying and corrosion. Maximum time between
use and preparation: 2 hours. The Trocar Cannula is designed for 500 sterilization cycles.

Disassembly

Before decontamination disassemble the Trocar Cannula as described in section 6.4 “Disassem-
bling Trocar Cannula”. Remove seal cap, internal seal and O-ring.

Manual cleaning

• Rinse and clean all surfaces and lumina thoroughly with cleaning solution and suitable brushes.

• Place Trocar Cannula in an ultrasonic bath with cleaning solution, if necessary.

• Rinse all components of the Trocar Cannula thoroughly with cleaning gun and deionized water.

Machine cleaning and disinfection

• Connect all components of the Trocar to the cleaning connections of the machine, if necessary.

• Use a fine-mesh basket for small parts, such as seals and O-rings.

• Run a standard machine cleaning and thermal disinfection cycle.

Autoclaving

Autoclave in vacuum autoclave (class B or S as per EN 13060) at 135 °C for at least five minutes*.
Do not exceed the maximum load of the sterilizer when sterilizing multiple instruments in one sterili­zation cycle. Autoclaving without vacuum must be followed by a drying phase. Allow the Trocar
Cannula to dry in a bag for at least one hour at room temperature with the paper side up..

* The temperature holding times conform to the national guidelines and standards with the maximum holding time 25
minutes.

Assembly

• Make sure that all parts of the Trocar Cannula are completely dry after preparation.

• The flap in the valve body must be open when screwing the spacer with internal seal to the valve

body.

• Assembly the Trocar Cannula in reverse order of disassembly (see chapter 6.4 “Disassembling
Trocar Cannula”).

MN009-938-S0 ERGO 300 33

7.3 Preparation of motor

Frequent preparation has little effect on the electric motor. The end of the product service life nor­mally results from wear and damage caused by use. The electric motor is designed for 250 steriliza­tion cycles.

Risk of damage

• Motor must not be cleaned with ultrasonic or compressed air.

• Do not kink the motor cable, otherwise it may be broken.

• Use BOWA cleaning and care spray exclusively, other care sprays may destroy the motor.

• Steam sterilize the micromotor in a sterilization bag and then allow to cool.

At the site of use

Remove surface dirt with a disposable cloth or paper towel.

Storage and transport

Avoid long wait times before preparation because of the risk of drying and corrosion; maximum peri­od between use and preparation is eight hours.

Preparation for cleaning

Remove dirt on the electric motor with a disposable cloth or paper towel. Unscrew motor cap and
handpiece holder and remove with cable. Do not place electric motor in ultrasonic bath.

Disassembly

Before decontamination, disassemble motor as described in “Disassembling motor”.

Manual cleaning

Use a neutral cleaning agent, cleaning brushes and deionized water (< 38 °C).

• Rinse and brush off dirt on the electric motor, motor cap with cable and handpiece holder.

• Apply cleaning agent to all surfaces and intermediate spaces with brush and brush thoroughly.

• Rinse electric motor, motor cap with cable and handpiece carrier thoroughly under running water.

Automatic cleaning and disinfection

Equipment: cleaning and disinfecting machine with special racks that connect
motors to the cleaning and disinfecting machine and rinse out all channels.
Wash the motor from the front. Use only neutral cleaning agents.

• Position electric motor in rack (ensure that channels are washed by connecting them to the
cleaning and disinfecting machine.

• Place the motor cap and cable, and handpiece holder, in the basket.

• Set a cleaning cycle that offers sufficient cleaning and rinsing. Perform the final rinse with deion-

ized water.

• Perform a 10-minute rinse cycle (disinfection) at 93°C to facilitate thermal disinfection.

• When removing the electric motor, check the motor cap and cable and handpiece holder to verify

whether soiling is still visible in the gaps and the grooves. If necessary, repeat the cycle or clean
manually.

34 ERGO 300 MN009-938-S0

Manual disinfection

For manual disinfection, spray the electric motor, handpiece holder, motor cap with the plug and
cable underneath it, and the handpiece holder with isopropyl-based disinfectant spray.

Drying

If a drying programme is not provided by the washer-disinfector, the electric motor must be dried in a
drying cabinet at 60 °C.

Inspection, maintenance and assembly

• Perform a visual inspection to check for damage, corrosion and wear and tear.

• Screw the motor to spray attachment (art. no. 905-007) and spray with Nou-Clean spray for

about three seconds and briefly wipe with a moist cloth (see instructions on spray can).

• After spraying, attach the handpiece holder and screw the cable with motor cap onto the electric
motor..

Packaging

• Storage of single unit: Pack the electric motor in individual packaging for sterile items. The bag
must be large enough to ensure that the seal is not subject to strain. When using sterilization
container, observe the instructions of the manufacturer.

• Storage of set: Sort electric motors on trays intended for this purpose or place them on all­purpose sterilization trays.

Sterilization

• Autoclave in the vacuum autoclave (Class B or S as per EN 13060) at 135 °C for at least 5
minutes*.

• When sterilizing several instruments during one sterilization cycle, do not exceed the maximum
sterilizer load.

• A drying cycle must be added in the case of autoclaves without a post-vacuum function. Allow
the electric motor to dry in the bag for at least 1 hour at room temperature with the paper side
facing upwards.

* Temperature exposure times are based on country-specific guidelines and standards. Maxi
mum exposure time: 25 minutes.

Storage

If the sterilized electric motor is not used immediately after sterilization, the material packaging must
be labeled with the sterilization date.

MN009-938-S0 ERGO 300 35

7.4 Preparation of gear unit

The gear unit is designed for 250 sterilization cycles.

Oil may leak from the pressure compensation opening of the gear unit under pressure.
Wipe off with a moist cloth.

Do not immerse gear unit in liquids.

Disassembly

Disassemble gear unit as described in section 6.6 “Disassembly o gear unit and Morcellator”.

Manual cleaning

Use neutral and alkaline cleaning agents, cleaning brushes and deionized water.

• Rinse and brush surfaces and intermediate spaces thoroughly with neutral and alkaline cleaning
agent.

• Brush and rinse lumen thoroughly with neutral and alkaline cleaning agent.

• Rinse all surfaces and lumina with deionized water for at least 10 minutes. Make sure that all in-

termediate spaces are cleaned.

Machine cleaning and disinfection

• Equipment: Cleaner and disinfector with special racks that ensure that channels are cleaned.
Use only neutral cleaning agents.

• Place the gear unit in the load carrier (ensure that the channels can be rinsed).

• Place seal holder and membrane screw in basket

• Set a cleaning cycle that offers sufficient cleaning and rinsing. Perform the final rinse with

deionized water.

• Perform a 10-minute rinse cycle at 93 °C to facilitate thermal disinfection.

• When removing the gear unit, the seal holder and the membrane screw, check whether visible

contamination still remains in the gaps and the grooves. If necessary, repeat the cycle or clean
manually.

Maintenance, lubricating gear unit

• Perform a visual inspection to check for
damage, corrosion and wear and tear.

• Use Nou-Clean spray exclusively.

• Attach the spray attachment for handpiec-

es (art. no. 905-006) to Nou-Clean spray
and sprayngear unit for about three se­conds and briefly wipe with a moist cloth
(see instructions on spray can).

36 ERGO 300 MN009-938-S0

Sterilizing gear unit

Autoclave in the vacuum autoclave (Class B or S as per EN 13060) at 135 °C for at least 5
minutes*. When sterilizing several instruments during one sterilization cycle, do not exceed the max­imum sterilizer load. Adrying cycle must be added in the case of autoclaves without a post-vacuum
function. Allow the gear unit to dry in the bag for at least 1 hour at room temperature with the paper
side on top.

* Temperature exposure times are based on country-specific guidelines and standards. Maximum exposure time: 25 minutes.

Assembly

• Make sure that all parts of the gear unit are completely dry after preparation.

• Assemble gear unit in reverse order of disassembly (see Chapter 6 Use).

7.5 Preparation of cutting tubes, protective tubes, filling rods, seals, seal unit and
myoma drill

Clean all products with suitable cleaning brushes.

Reprocessing restrictions

The end of the product service life is normally determined by wear and tear and damage through
use. The cutting tubes are designed for a service life of 20 cycles.

At the location of use

Remove surface soiling with a disposable cloth/paper towel.

Storage and transport

No special requirements – avoid long periods before preparation to prevent the danger of drying-out
and corrosion, maximum time between use and preparation is two hours.

Preparation for cleaning

Disassemble seal unit into component parts under running water (see 6.6 Disassembly of gear unit
and morcellator) Disassemble gripper and remove seal caps. Wash visible soiling from all
components.

Manual cleaning

• Use disinfectant solution, neutral or alkaline cleaning agents, suitable cleaning brushes and de­ionized water. Wipe all surfaces thoroughly with disinfectant (exposure time as specified by the
disinfectant manufacturer).

• Immerse all parts in alkaline cleaning agent (exposure time as specified by the cleaning agent
manufacturer). Use suitable brushes that can reach all parts of the lumen for cavities.

• Rinse all part thoroughly under running water.

Automatic cleaning and disinfection

Equipment: Cleaning/disinfection device with a special load carrier which facilitates the connection
of parts with cavities to the cleaning/disinfection device and the rinsing of channels. Use a fine­mesh basket for small parts. Use neutral or alkaline cleaning agents at the recommended concen­tration.

• Place the cutting tubes, protective tubes, myoma drills, grippers and ergonomical handle in the
load carrier (ensure that the channels can be rinsed).

• Place seal holder, membrane screw, membrane seal, cross seal and seal caps of gripper in the
fine-mesh basket and close the basket.

• Set a cleaning cycle that offers sufficient cleaning and rinsing. Perform the final rinse with deion­ized water.

• Perform a 10-minute rinse cycle at 93°C to facilitate thermal disinfection.

• When removing the products, check whether visible contamination still remains in the gaps and

the grooves. If necessary, repeat the cycle or clean manually.

MN009-938-S0 ERGO 300 37

Drying

If a drying programme is not provided by the washer-disinfector, all parts must
be dried in a drying cabinet at 60 °C.

Inspection, maintenance and assembly

• Perform a visual inspection to check for damage, corrosion and wear and tear.

• Check cutting edge for damage and rotary components for bending.

• Check that rotary components move smoothly.

• Check seals and seal caps for elasticity, cracking, deformation and porosity.

Packaging

• Storage of single unit: Pack parts in individual packaging for sterile items. The bag must be large
enough to ensure that the seal is not subject to strain. When using sterilization container, ob­serve the instructions of the manufacturer.

• Storage of set: Sort parts on trays intended for this purpose or place them on all-purpose sterili­zation trays.

Risk of damage

The blade of the cutting tube may damage the sterile packaging.

Sterilization of handle, cutting tubes, protective tubes, trocar dome, myoma drills, seal hold­er and membrane screw

Autoclave in the vacuum autoclave (Class B or S as per EN 13060) at 135 °C for at least 5minutes*.
When sterilizing several instruments during one sterilization cycle, do not exceed the maximum
sterilizer load. A drying cycle must be added in the case of autoclaves without a post-vacuum func­tion. Allow products to dry in the bag for at least 1 hour at room temperature with the paper side on
top.

* Temperature exposure times are based on country-specific guidelines and standards. Maximum exposure time: 25 minutes.

The instructions throughout chapter 7 have been validated as being suitable for preparing a medical device to be reused. The preparer
is responsible for ensuring that the actually performed preparation involving the equipment, materials and personnel used in the prepa­ration facility achieves the desired results. This normally requires validation and routine monitoring of the procedure. Likewise, each
deviation from the provided instructions should be carefully analyzed for its effect and potential detrimental consequences.

38 ERGO 300 MN009-938-S0

8 Maintenance and repair

8.1 General maintenance

Maintenance, motor cable

• Replace a damaged motor cable with a new one (art. no. 905-013)

Maintenance, protective tube and filling rod

• Replace a damaged protective tube or filling rod with a new one.
Protective tube Ø 12 mm (art. no. 905-212)
Obturator Ø 12 mm (art. no. 905-012)
Protective tube Ø 15 mm (art. no. 905-215)
Obturator Ø 15 mm (art. no. 905-015)
Protective tube Ø 20 mm (art. no. 905-220)
Obturator Ø 20 mm (art. no. 905-020)

Maintenance, seals for Trocar

• Replace damaged seals with new ones.
Set gasket holder with membrane screw (art. no. 905-011), package for 1 piece

Maintenance, seals in seal unit

• Replace damaged seals with new ones
Membrane seal (art. no. 905-512) for use with protective tube Ø 12-20 mm
Cross seal (art. no. 905-009) suitable for all cutting tube diameters

Wartung, Adapter zu NouClean-Spray

• Replace missing adapters with new ones
Adapter for Nou-Clean spray for care of electric motor (art. no. 905-007)
Adapter for Nou-Clean spray for care of gear unit (art. no. 905-006)

8.2 Replacing the control unit fuse

Users can replace faulty control unit fuses themselves. These are located at the rear of the device in the
fuse slot beside the power switch:

1. Switch the device off.

2. Unplug the power plug.

3. Open the fuse slut using a screw driver

4. Replace the faulty fuse T 1 AL 205VAC

5. Slide the fuse holder back in and close the fuse slot.

6. Check the mains volatage shown on the fuse slot

7. Plug in the power plug again

1. Fuse slot locking mechanism

2. Display window for voltage setting

3. Fuse slot

1 2 3 4 5

MN009-938-S0 ERGO 300 39

4. Fuse 1

5. Fuse 2

8.3 Safety inspections

The performance of safety inspections on medical devices is required by the legislation of several countries.
The safety inspection is a regular safety check that is compulsory for those operating medical devices. The
objective of this measure is to ensure that device defects and risks to patients, users or third parties are
identified in good time.

An inspection interval of 2 years applies for the ERGO 300 - Morcellator.
Nouvag offers a safety inspection service for its customers. See the appendix of the manual

under “Service Centers”. Please contact our technical service department for more information.
Additional international service centers are listed on the Nouvag web site:

www.nouvag.com > Service > Servicestellen

8.4 Malfunction and troubleshooting

Malfunction

Cause

Solution

Refer to the operating

instructions

Device is not op­erational

(display is not on)

Control unit not switched
on

Set the power switch
“I/O” to “I”

5.2.1 Assembly of the Morcellator set
with protective tube (option 1)

5.2.2 Assembly of the Morcellator set
with Trocar Cannula (option 2)

Power connection not
established

connect

5.2.1 Assembly of the Morcellator set
with protective tube (option 1)

5.2.2 Assembly of the Morcellator set
with Trocar Cannula (option 2)

Incorrect operating voltage

Check the mains voltage

5.1. Connection to the power supply

Faulty fuse

Replace the fuse

8.2 Replacing the control unit fuse

Motor does not
run

Motor not switched on

Switch on the motor using
the treadplate

6.1 Using the control unit

Motor not connected

Connect the motor cable to
the control unit

5.2.1 Assembly of the Morcellator set
with protective tube (option 1)

5.2.2 Assembly of the Morcellator set
with Trocar Cannula (option 2)

Gear unit not correctly in­stalled

Press the electric motor
firmly onto the gear unit
coupling until it clicks into
position and check that it is
secure by moving it slightly
in the opposite direction.

5.2.1 Assembly of the Morcellator set
with protective tube (option 1)

5.2.2 Assembly of the Morcellator set
with Trocar Cannula (option 2)

Foot switch does
not operate
(display is on)

Foot switch not connected

Plug foot switch cable into
the foot switch socket.

5.2.1 Assembly of the Morcellator set
with protective tube (option 1)

5.2.2 Assembly of the Morcellator set
with Trocar Cannula (option 2)

If a fault cannot be rectified, please contact your supplier or an authorized service centre.
The addresses are provided on the last page of the operating instructions.

40 ERGO 300 MN009-938-S0

8.5 Spare parts list with order numbers

Accessories Art. no.

Morcellator Gear unit complete including seals ---------------------------------------------------------------------------- 905-004
Trocar Cannula Ø 12 mm -------------------------------------------------------------------------------------------------- 905-312
Trocar Cannula Ø 15 mm -------------------------------------------------------------------------------------------------- 905-315
Protective tube Ø 12 mm -------------------------------------------------------------------------------------------------- 905-212
Protective tube Ø 15 mm -------------------------------------------------------------------------------------------------- 905-215
Protective tube Ø 20 mm -------------------------------------------------------------------------------------------------- 905-220
Obturator Ø 12 mm --------------------------------------------------------------------------------------------------------- 905-012
Obturator Ø 15 mm --------------------------------------------------------------------------------------------------------- 905-015
Obturator Ø 20 mm --------------------------------------------------------------------------------------------------------- 905-020
Myoma drill Ø 10 mm ------------------------------------------------------------------------------------------------------- 905-010
Cutting tube Ø 12 mm ------------------------------------------------------------------------------------------------------ 905-112
Cutting tube Ø 15 mm ------------------------------------------------------------------------------------------------------ 905-115
Cutting tube Ø 20 mm ------------------------------------------------------------------------------------------------------ 905-120
Handle for gear unit --------------------------------------------------------------------------------------------------------- 905-005
Electric motor with 3 m motor cable ------------------------------------------------------------------------------------- 905-002
Motor cable 3 m, spare part for electric motor ------------------------------------------------------------------------ 905-013
Membrane seals for seal unit for Ø 12-20 mm ----------------------------------------------------------------------- 905-512
Cross seal for all cutting tube diameters Ø 12-20 mm ------------------------------------------------------------- 905-009
Gasket holder ----------------------------------------------------------------------------------------------------------------- 905-011

To order additional parts, please contact our customer service department.

The user manual is not available in printed form with this product. The user manual as PDF is on the CD­ROM that was included in the delivery. A CD-ROM drive and the Adobe Acrobat software is needed to read
or print this user manual. To order the user manual in printed form please check on the type plate for the
address or the website. If you send us the article number MN009-938 with the language code and the note
“Printed copy”, a printed manual will be sent to you free of charge.

8.6 Information on disposal

Electrical and electronic devices that have reached the end of their service life comprise hazardous
waste and may not be disposed of together with household waste. Prevailing national and local dis­posal regulations apply.

When disposing of the device, device parts and accessories, the requirements specified in
legislation must be followed.
To ensure environmental protection, old devices can be returned to the dealer or manufacturer.

Motors that have reached the end of their service life must not be disposed of with household waste.
Motors must be sterilized before disposal. The national and local regulations for disposal of electron­ic waste must be observed.
If they are not sterilized before disposal, please observe the national and local regulations for dis­posal of infectious waste.

MN009-938-S0 ERGO 300 41

9 Electromagnetic compatibility (EMC)

Bemerkung:
The Product subsequently referred to herein always denotes the ERGO 300 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.

WARNING

Use of portable phones or other radio frequency (RF) emitting equipment near the product may cause unex­pected or adverse operation.

WARNING

The product shall not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is
necessary, the product shall be tested to verify normal operation in the configuration in which it is being
used.

Compliant Cables and Accessories

WARNING

The use of accessories, transducers and cables other than those specified may result in increased emis­sions or decreased immunity performance of the product.
The table below lists cables, transducers, and other applicable accessories for which the manufacturer
claims EMC compliance.

NOTE: Any supplied accessories that do not affect EMC compliance are not listed.

Description

Length max.

Electronicmotor 31ESS

2,9 m

Vario Footpedal IP68

2,9 m

Guidance and manufacturer’s declaration – electromagnetic emissions

The Product is intended for use in the electromagnetic environment specified below. The customer or the
user of the Product should assure that it is used in such an environment.

Emissions 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 likely to cause any interfer­ence in nearby electronic equip­ment.

RF emissions
CISPR 11

Class B

The Product is suitable for use in
all establishments, including do­mestic establishments and those
directly connected to the public
low-voltage power supply network
that supplies buildings used for
domestic purposes.

Aussendung von Oberschwingungen
nach IEC 61000-3-2

Klasse A

Voltage fluctuations/flicker emissions
IEC 61000-3-3

Complies

42 ERGO 300 MN009-938-S0

Guidance and manufacturer’s declaration – electromagnetic immunity

The Product is intended for use in the electromagnetic environment specified below. The customer or the
user of the Product should assure that it is used in such an environment.

Immunity tests

IEC 60601 Test level

Compliance level

Electromagnetic envi­ronment - guidance

Electrostatic discharge
(ESD)
IEC 61000-4-2

+/- 6 kV contact

+/- 6 kV contact

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.

+/- 8 kV air

+/- 8 kV air

Electrical fast
transient/burst
IEC 61000-4-4

± 2 kV for power supply

± 2 kV for power supply

Mains power quality
should be that of a typical
commercial or hospital
environment.

±1 kV for input/output
lines

±1 kV for input/output
lines

Stoßspannungen (Surg­es) nach IEC 61000-4-5

+/- 1 kV differenti­al
mode

+/- 1 kV differenti­al
mode

Mains power quality
should be that of a typical
commercial or hospital
environment.

+/- 2 kV common
mode

+/- 2 kV common
mode

Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11

< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle

40 % UT
(60 % dip in UT)
for 5 cycles

70 % UT
(30 % dip in UT)
for 25 cycles

< 5 % UT
(> 95 % dip in UT)
for 5 sec

< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle

40 % UT
(60 % dip in UT)
for 5 cycles

70 % UT
(30 % dip in UT)
for 25 cycles

< 5 % UT
(> 95 % dip in UT)
for 5 sec

Mains power quality
should be that of a typical
commercial or hospital
environment.

If the user of the Product
requires continued

operation during power
mains interruptions, it

is recommended that the
Product be powered

from an uninterruptible
power supply or a

battery.

Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8

3 A/m

30 A/m

Power frequency magnet­ic fields should be at lev­els characteristic of a
typical location in a typical
commercial or hospital
environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

MN009-938-S0 ERGO 300 43

Guidance and manufacturer’s declaration – electromagnetic immunity for not life support equipment

The Product is intended for use in the electromagnetic environment specified below. The customer or the
user of the Product should assure that it is used in such an environment.

Immunity tests

IEC 60601
Test level

Compliance
level

Electromagnetic environment - guid­ance

Portable and mobile RF communications
equipment should be used no closer to

any part of the Product, including cables,
than the recommended separation dis­tance calculated from the equation appli­cable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF
IEC 61000-4-6

3 V rms
150 kHz to 80

MHz
outside ISM

bands

3 V rms
150 kHz to 80

MHz
outside ISM

bands

d = 1,2 × √P

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to 2.5

GHz

3 V/m
80 MHz to 2.5

GHz

d = 1,2 × √P 80 MHz to 800 MHz
d = 2,3 × √P 800 MHz to 2,5 GHz

where P is the maximum output power
rating in the transmitter in watts (W) ac­cording to the transmitter manufacturer
and d is the recommended

separation distance in meters (m).

Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compli­ance level in each frequency rangeb.

Interference may occur in the vicinity of
equipment marked with the following
symbol:

Note 1:

At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

a

Fixed strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic
environment due to fixed RF transmitters, and electromagnetic site survey should be con­sidered. If the measured field strength in the location in which the Product is used exceeds
the applicable RF compliance level above, the Product should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Product

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

44 ERGO 300 MN009-938-S0

Recommended separation distances between
portable and mobile RF communications equipment and the not life support equipment

The Product is intended for use in an electromagnetic environment 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 communications equipment (transmitters) and
the Product as recommended below, according to the maximum output power of the communications
equipment.

Rated maximum output
power of transmitter
(W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz
d = 1,2 × √P

80 MHz to 800 MHz
d = 1,2 × √P

800 MHz to 2,5 GHz
d = 2,3 × √P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the higher frequency range
applies.

Note 1:

At 80 MHz and 800 MHz, the separation distance fort the higher frequency range
applies.

Note 2:

These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

MN009-938-S0 ERGO 300 45

Servicecenters

Switzerland

Nouvag AG
St. Gallerstr. 23-25
CH-9403 Goldach
Phone: [phone]
Fax: [phone]
[email protected] │ www.nouvag.com

Germany

Nouvag GmbH
Schulthaißstrasse 15
D-78462 Konstanz
Phone: [phone]
Fax: [phone]
Info-[email protected] │ www.nouvag.com

USA

Nouvag USA Inc.
18058 Albyn Court
Lake Hughes, CA 93532 USA
Phone: [phone]
Fax: [phone]
Free of charge: [phone]
[e-mail] │ www.nouvag.com

Nouvag AG
St. Gallerstr. 23-25
CH-9403 Goldach │ Switzerland

Phone: [phone]
Fax: [phone]
[e-mail] │ www.nouvag.com

Distributed by:

1275

MN009-938-S0-EN 08/14

Printed in Germany Subject to technical and design changes Copyright by BOWA-electronic, Gomaringen │ Germany

BOWA-electronic GmbH & Co. KG
Heinrich-Hertz Strasse 4–10
D-72810 Gomaringen │ Germany

Phone: [phone]
Fax: [phone]
[e-mail] │ www.bowa-medical.com

CE marked according
to Medical Device
93/42/EWG