Bowa ERGOact User manual

12578EN-S1
Instructions for Use
ERGOact
en

BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 1
Key
Handle
COMFORT plug
Rotation wheel
Shaft tube
Activation key
(for coagulation only)
Release button for disassembly
Insert
with jaw
Maryland insert
Kelly insert
Fenestrated insert

2 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
Handle
Shaft tube

BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 3
Contents
Key ............................................................................................................................1
Contents .................................................................................................................... 3
1 Applying the instructions for use ...........................................................................4
1.1 Scope of validity .....................................................................................................4
1.1.1 Sets .................................................................................................................4
1.1.2 Spare Parts ......................................................................................................4
1.2 Symbols and markings ...........................................................................................5
2 Intended Purpose .................................................................................................. 6
2.1 Indications .............................................................................................................6
2.2 Contraindications ...................................................................................................6
3 Safety instructions ..................................................................................................7
3.1 Device-related ........................................................................................................7
3.2 Use-related .............................................................................................................8
3.2.1 Patients with pacemakers ...............................................................................9
3.3 EMC information ....................................................................................................9
4 Description .............................................................................................................10
4.1 Mode of operation .................................................................................................10
4.2 Procedure during use ............................................................................................10
4.3 Clinical benefit .......................................................................................................10
5 Assembly ................................................................................................................11
6 Operation ...............................................................................................................12
6.1 Before use ..............................................................................................................12
6.2 Function test in the operating theatre ...................................................................12
6.3 During the operation .............................................................................................12
6.4 Removal .................................................................................................................14
6.5 After use .................................................................................................................14
6.5.1 Spare parts .....................................................................................................14
7 Dismantling ............................................................................................................15
8 Pre-conditioning ....................................................................................................16
8.1 General information ...............................................................................................16
8.2 Device-specific information ....................................................................................16
8.3 Inspection ..............................................................................................................18
8.4 Sterilisation packaging ...........................................................................................19
9 Ambient conditions ................................................................................................19
9.1 Transport and storage ...........................................................................................19
9.2 Operation ...............................................................................................................19
10 Technical data ......................................................................................................19
11 Disposal ................................................................................................................ 20
12 Symbols on packaging .........................................................................................20

Applying the instructions for use
4 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
1 Applying the instructions for use
These instructions for use are part of the device.
BOWA-electronic GmbH & Co. KG assumes no liability and provides no warranty
whatsoever for any damage or consequential damage arising
from non-compliance with these instructions for use.
Read the instructions for use, in particular the section on safety (see chapter 3 “Safety
instructions”) carefully and thoroughly before use.
Keep the instructions for use in a safe place throughout the service life of the device.
Keep the instructions for use accessible to operating theatre personnel.
Give the instructions for use to each successive owner or user of this device.
Always update the instructions for use whenever you receive additional information
from the manufacturer.
1.1 Scope of validity
These Instructions for use apply only to the devices specified in chapters 1.1.1 and 1.1.2.
1.1.1 Sets
1.1.2 Spare Parts
REF
360 mm 460 mm Label
770-660 770-661 ERGOact, Maryland
770-662 770-663 ERGOact, Kelly
770-664 770-665 ERGOact, fenestrated
REF
360 mm 460 mm Label
770-600 ERGOact, handle
770-610 770-620 ERGOact / ERGOeco, shaft tube, Ø 5 mm
770-611 770-621 ERGOact / ERGOeco, Insert Maryland
770-612 770-622 ERGOact / ERGOeco, Insert Kelly
770-613 770-623 ERGOact / ERGOeco, Insert fenestrated

Applying the instructions for use
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 5
1.2 Symbols and markings
Structure of warning notices:
Danger levels in warning notices:
Tips:
SIGNAL WORD
Type, source and consequences of the danger (personal injuries)!
Measure for avoiding the danger.
Symbol Danger level Probability of occurrence Consequences of
non-compliance
DANGER Immediate risk Death,
severe injury
WARNING Possible risk Death,
severe injury
CAUTION Possible risk Minor injuries
NOTE Possible risk Property damage
Tips to make your work easier or supplementary information for a
procedure.

Intended Purpose
6 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
Other symbols and markings:
2 Intended Purpose
Electrosurgical equipment for cutting and coagulation of tissue.
2.1 Indications
The ERGOact instruments are designed for the grasping, bipolar coagulation and
separation of biological tissue during minimally invasive surgery.
BOWA recommends using this device on the BOWA ARC generators.
2.2 Contraindications
The medical device must not be used if, in the opinion of an experienced surgeon or
according to the current technical literature, such usage could endanger either the
patient, e.g. due to their general condition, or other persons.
Do not use the medical device if its surgical techniques are contraindicated.
Never use the medical device on the heart, central circulatory system or central nervous
system.
Symbol / marking Meaning
Prerequisite for an activity
 Activity with one step
1.
2. Activity with several steps in strict sequence
Result of preceding activity
• List (first level)
• List (second level)
Emphasis Emphasis

Safety instructions
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 7
3 Safety instructions
3.1 Device-related
• The instrument may only be used by trained medical staff. The surgeon and the medical
professionals must be trained in, and hence be familiar with, the fundamental principles,
codes of practice and risks of HF surgery.
Read the instructions for use carefully and thoroughly before using the device.
All serious incidents occurring in connection with the device must be reported to the
manufacturer and to the competent authority of the country in which the user is
established.
• The devices are supplied in non-sterile condition and must be cleaned and sterilised
before use.
• Risk of injury from sharp edges.
• The device must not be operated in AUTOSTART mode.
• You are responsible for ensuring the instruments are sterile
• Observe the following:
Always clean and sterilise the handle and the insert before use (see chapter 8 “Pre-
conditioning”) .
Use only cleaning, disinfection and sterilisation methods that have been validated for
the specific devices and products concerned.
Comply with the validated parameters for each cycle.
Comply with the legal regulations applicable in your country, as well as the
hygiene regulations of the hospital.
Do not use gas sterilisation or hot air sterilisation as these methods can damage the device.
• To avoid burns (thermal overload), observe the following points:
Make sure that all electrical plug connections are correctly connected.
Do not strain the devices beyond their mechanical limits
(e.g. by excessively bending, kinking, or crushing them or by running them over with
an instrument trolley).
The maximum rated voltage of the instrument must not be exceeded (see chapter 10
“Technical data”).
Comply with the recommended power settings and maximum voltage of the
designated HF generator.
The effectiveness of the settings must be assessed by the user.
• In order to rule out the risk of injuries and electric shocks for the patient and the operating
personnel, ensure that the power supply is switched off before connecting the HF connection
cable and accessories to and removing them from the electrosurgical device.
• Cables must never be inserted or removed while the device is activated.
• Do not repair or service defective devices:
Check the device for damage, in particular for the integrity of the insulation, after
reprocessing and before use.

Safety instructions
8 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
Replace and dispose of defective devices immediately.
Comply with the Instructions for use of the HF device and the general instructions for
electrosurgical operations!
• If necessary, use a suitable tester (e.g. BOWA REF 050-230) to check if the device is in
proper working order.
• The "BF" / "CF" applied part of the HF device used is extended by the instrument
connected to it.
3.2 Use-related
• Make sure that the HF generator you intend to use is connected to a matching instrument
handle (see chapter 1.1 “Scope of validity”).
• Run a function test using a gauze soaked in saline solution before use.
• Always insert the bipolar instrument into the body under visual control.
• Only activate the jaws with adequate visibility.
• For coagulation of closely situated structures such as nerves or the ureter, proceed with
the utmost caution and keep your distance.
• The jaws must not be too full. Never grasp too much tissue for coagulation.
• Improper use of HF current can lead to burns and explosions:
Perform electrosurgical operations only with insufflation of non-flammable gases (CO2).
Avoid direct skin contact with HF cables.
Avoid contact with flammable gases and liquids.
• Improper use of the device can cause injury to the patient::
Avoid skin-to-skin contact between the HF cable and the patient.
When plugging in or removing the HF cable, always take hold of the connector, never
pull on the cable itself.
Do not place the instrument on the patient. This will prevent injury if the HF is
inadvertently activated.
Avoid contact with metallic objects (clips, stents, etc.) in the area around the active
jaws. They can affect energy output and lead to undesired effects.
• The jaws can get hot enough to cause a thermal lesion.
• The HF cable may cause interference to imagery on monitors:
Never route the HF cable alongside a camera cable.
Do not lay the HF cable in loops.
Consult the instructions for use of the BOWA HFgenerators foradditional information
on interference with other devices.
• Electrical safety is improved through the use of plastic trocars.

Safety instructions
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 9
3.2.1 Patients with pacemakers
Malfunction or destruction of the pacemaker can endanger the life of the patient or result
in irreversible injuries to the patient.
Consult the cardiologist before performing
HF surgery on patients who wear pacemakers.
Set the demand pacemaker to a fixed frequency.
Ensure that the pacemaker does not come into contact with the jaws.
Have an operable defibrillator to hand.
Carry out a postoperative pacemaker check.
3.3 EMC information
Medical electrical devices are subject to special EMC precautions, so please follow the
below-mentioned instructions.
The BOWA accessory is only intended to be connected to BOWA specified HF devices.
Using the accessory with medical devices from other manufacturers can result in
higher emission levels or reduced interference immunity.
NOTE
Combining medical devices is only safe if
the lowest power rating (rated voltage/current form, ...) is used for all
devices in the desired combination(s).
the purpose and the interface specification of the devices used in the
combination allow this.
The instructions for use and interface specifications of medical devices
used in combination must be strictly observed.

Description
10 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
4 Description
4.1 Mode of operation
In bipolar HF surgery, tissue coagulation is achieved by applying a high-frequency AC
current, which generates heat.
The ERGOact bipolar coagulation instrument is an invasive surgical instrument for use in
laparoscopic or open surgery.
It is used through surgically produced access openings in conjunction with devices for
endoscopic use, such as trocars and optics.
The active jaws are the uninsulated areas of the insert. The HF current flows from one
electrode of the instrument through the biological tissue to the other electrode to
produce the desired localised tissue effect.
The insert can be rotated and positioned by a rotation wheel on the handle.
4.2 Procedure during use
1. Prior to use, clean and sterilise the new product that is shipped in non-sterile condition
from the factory.
2. Check the completeness of the individual parts and mount the instrument
(see chapter 5 “Assembly”).
3. Connect the HF generator you plan to use to a matching instrument handle (see
chapter 1.1 “Scope of validity”).
4. Do not exceed the maximum permissible voltage (see chapter 10 “Technical data”).
5. Always perform a thorough visual inspection and function check before use.
6. Insert the jaws into the trocar sleeve in the closed position.
7. Insert the bipolar instrument into the body under visual control.
8. Perform the operation only with adequate visibility.
9. After the operation, separate the instrument from the HF generator and dismantle it.
10. Reprocess the devices after each use.
4.3 Clinical benefit
During treatment with the BOWA HF-instruments, the patient benefits from established
and safe state-of-the-art electrosurgical instruments used in cutting, coagulation and
vessel ligation procedures in a variety of electrosurgical interventions within almost all
surgical disciplines.

Assembly
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 11
5 Assembly
Assemble the instrument in the following sequence:
1. Introduce the instrument into the shaft tube.
2. Take hold of the jaw and carefully turn it to tighten it.
Shaft with insert is now ready to mount on the handle.
3. Whilst ensuring that the jaws are closed, introduce the shaft tube with insert into the
completely opened handle until you hear it click into place.
Once the shaft with insert is completely and correctly positioned inside the handle,
the instrument’s jaws move when the rear handle shank moves. The instrument is
now completely assembled.

Operation
12 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
6 Operation
6.1 Before use
The instrument is assembled, see chapter 5 “Assembly”.
1. Switch on the HF device and connect the HF cable to the HF device.
2. Set the required settings on the HF device.
3. Always perform a thorough visual inspection and function check before use (see
chapter 8.3 “Inspection”).
6.2 Function test in the operating theatre
1. Check whether the jaws can be easily opened and closed using the handle.
2. Check the activation using the finger switch or foot switch.
The activation signal sounds when the finger switch or foot switch is activated.
6.3 During the operation
WARNING
Risk of patient injury!
Use only compatible HF generators.
Select the settings of the HF device to the mode required for the
operation.
Use only suitable devices and accessories wherever possible.
Use only intact and sterilised devices.
WARNING
Risk of patient injuries from burns or explosion!
Avoid contact with flammable gases and liquids, such as skin cleansers,
disinfectants and anaesthetic gases.
Avoid direct skin contact with HF cables.
Skin-to-skin contact (e.g. between the patient's arms and body) should
be avoided, e.g. by inserting dry gauze.
WARNING
Risk of patient injury due to tissue clamping, especially with limited visibility!
Prepare the tissue to be coagulated by freeing it as far as possible to prevent
it from becoming pinched!
Perform the operation only with adequate visibility.

Operation
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 13
Introducing the instrument
1. Close the handle in order to keep the jaws closed.
2. Insert the instrument into the trocar sleeve.
Grasping, clamping and sealing tissue
1. Position the branches at the operation site.
2. Turn the rotary wheel (with the jaws open) to align the jaws to the target tissue.
3. Place the tissue to be coagulated between the jaws.
4. Close the jaws to grasp the tissue.
Never grasp too much tissue.
5. Using the finger switch or the foot switch, activate the HF current of the HF generator
for coagulation:
A continuous acoustic signal sounds while the HF current is activated.
WARNING
Risk of patient injuries from hot jaws and release of steam!
Instrument tips may still be hot immediately after HF power has been
switched off.
Maintain sufficient distance between instrument tips and sensitive
tissue structures, such as nerves, pancreas or intestines.
Make sure that no laparoscopy instruments under thermal load are used
to prepare the tissue.
Do not lay any laparoscopy instrument on the patient.
WARNING
Risk of patient injury due to accidental activation of the laparoscopy instrument!
Never use the AUTOSTART function.
Do not switch on the HF current before the jaws are in contact with the
tissue to be coagulated.
Activating the instrument accidentally can cause injuries to the patient.
WARNING
Incomplete coagulation!
Never use the AUTOSTART function.
Do not switch on the HF current before the jaws are in contact with the
tissue to be coagulated.
Activating the instrument accidentally can cause injuries to the patient.

Operation
14 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
6. Release the actuated switch.
The tissue is coagulated.
The tissue has been grasped by the jaws and is coagulated.
6.4 Removal
1. Close the jaws by closing the handle.
2. Withdraw the instrument from the trocar sleeve.
6.5 After use
Prepare the laparoscopy instrument after use (see chapter 8 “Pre-conditioning”).
6.5.1 Spare parts
To order spare parts, contact your BOWA dealership or visit our website: www.bowa-
medical.com
WARNING
Incomplete coagulation due to contaminated jaws!
Clean the jaws using a damp cloth or a sterile plastic brush on a regular
basis if tissue adheres to them.
WARNING
Risk of patient injury due to damaged or broken-off parts!
Always check the instrument before use. All parts must be present.
WARNING
Defective, worn or contaminated jaws can cause the instrument to
malfunction!
Clean contaminated jaws using a damp cloth or a sterile plastic brush. See
also “Device-specific information”, page 16.
Inserts with damaged jaws must be replaced.

Dismantling
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 15
7 Dismantling
To dismantle the instrument, proceed as follows:
1. Hold open the rear handle shank.
2. Press the black button on the top of the handle.
3. Release the shaft by pulling it out of the handle and make sure the rear handle shank
does not lower again.
You have now separated the shaft from the handle.
4. Gently rotate the insert until it detaches.
5. Pull the insert out of the shaft tube.
The instrument is now dismantled.
1.
2.
3.

Pre-conditioning
16 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
8 Pre-conditioning
8.1 General information
The preparation affects this product. Observe the safety instructions and instructions for
checking the function of the product. In case of apparent damage or functional
impairment of the product, it must no longer be used.
The service life may vary depending on the demands placed on the product.
Manual pre-conditioning methods are not recommended due to their significantly lower
effectiveness.
Follow the chemical manufacturers’ statements on concentrations and exposure times.
The medical device manufacturer cannot be held liable if other types of cleaning agents
and disinfectants are used.
8.2 Device-specific information
Insulated parts must not come into contact with hard, sharp or heavy products, as this
could damage the electrical insulation.
CAUTION
Risk of infection from water sprayers and steam during the manual
pre-cleaning process!
Wear a face mask and protective clothing.
Adequate ventilation is recommended.
NOTE
Abrasives and metal brushes cause damage to the jaws!
Never clean the laparoscopy instrument using abrasives or metal
brushes.
NOTE
Compressed air causes damage to the instrument parts!
Restrict compressed air pressure to 3 bar or less for drying the
instrument parts.

Pre-conditioning
BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact 17
BOWA has verified a service life of 50 cycles under the condition of proper and professional use
and preparation; the actual service life may be higher or lower depending on the demands
placed on the product.
Re-conditioning step Description
Manual pre-cleaning
1.A Soak1
Soak the dismantled device at room temperature (<25°C) for at least
5 minutes immediately, but no later than 2 hours after use. Only use
enzymatic, aldehyde-free disinfectants which are suitable for
disinfecting medical devices (e.g., DGHM or FDA approval or CE
marking). Remove all visible debris with a soft plastic brush. BOWA
recommends the use of Gigasept®Instru AF (Schülke & Mayr GmbH).
1.B Ultrasound 2
Place the individual parts of the device in the ultrasonic bath for at least
5 minutes. BOWA recommends the use of Gigasept®Instru AF (Schülke
& Mayr GmbH).
2 Rinsing
Thoroughly rinse the individual parts of the device for at least 1 minute
at room temperature (<25°C) under flowing water (drinking water
quality or better). Allow residual water to drip off sufficiently.
Automatic cleaning, thermal disinfection and drying
3 Mechanical
cleaning 3
For the mechanical clean and disinfection stage, the shaft tube is
inserted into a rinsing sleeve and the handle is attached to an injector
nozzle. Insert is placed in a wire basket in the opened state.
Ensure that the cable is not kinked or pinched.
Use a washing and disinfecting device (WD) with certified efficiency (to
ISO 15883 and a neutral to slightly alkali (max. pH 11.5), enzymatic
cleaning agent without critical constituents. Depending on the
concentration, agents including alcohol- and/or aldehyde-containing
ingredients may be used.
BOWA recommends the use of neodisher®MediClean forte (Chemische
Fabrik Dr. Weigert) at 55°C for 10 minutes.
The intermediate rinse must comprise two rinsing steps using
demineralised water (each step taking 1 minute at >10°C).
4 Thermal
disinfection4
An A0value of >3000 must be respected.
BOWA recommends a temperature of 90°C for at least 5 minutes and
the use of demineralised water.
5 Drying
Drying is carried out according to the WD programme and depends on
the total load. The maximum temperature is 100°C for 25 minutes. If
necessary, dry with filtered compressed air at max. 3 bar.
6Inspection
After machine cleaning and disinfection, carry out a visual inspection to
check for residues.
Repeat the re-conditioning process if necessary.

Pre-conditioning
18 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206
8.3 Inspection
These devices are subject to wear when used as intended, depending on the intensity of
use. This wear arises from the design and construction of the devices and is unavoidable.
Replace the device if it has externally visible defects or does not function as described in
this manual. Please advise the manufacturer or the manufacturer’s authorised
representative in such cases.
After cleaning and disinfecting the device, perform a visual inspection and function
check of the individual instrument parts.
Handle
1. Check the actuation lever for ease of motion.
2. Check the insert for damage and corrosion.
Shaft tube
1. Check the insulation of the shaft tube for damage.
Insert
1. Check the jaws for cleanliness and damage.
2. Check the insulation of the insert for damage.
HF cable
1. Check the connector for damage and corrosion.
Re-conditioning step Description
Steam sterilisation
7Steam
sterilisation 5
Sterilise the product while assembled or dismantled.
BOWA recommends steam sterilisation using the fractionated vacuum method
with a sterilisation time of 3–20 minutes and a temperature of 134–137°C in a
suitable sterilisation packaging.
BOWA has validated:
1 Soaking in cold tap water for 5 minutes
2Ultrasonic bath for 5 minutes with Gigasept®InstruAF (Schülke & Mayr GmbH), 3% v/v
4 Thermal disinfection at 90°C for 5 minutes
5 Steam sterilisation: Half-cycle with 3 pre-vacuum phases at 132°C for 1.5 minutes, instrument
assembled, packaging: double in paper/foil sterilisation bag
CAUTION
Brittle or defective insulation can burn the patient!
Replace instrument components with damaged insulation.