Bowa ERGOact User manual

12578EN-S0
Instructions for Use
ERGOact
en

BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 1
Key
Handle
COMFORT plug
Rotation wheel
Shaft tube with insert
Activation key
(for coagulation only)
Release button for disassembly
Jaw
Maryland insert
Kelly insert
Fenestrated insert

2 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
Handle
Shaft tube

BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 3
Key ...................................................................................................... 1
1 Applying the instructions for use ...................................................... 4
1.1 Scope of validity .....................................................................................................4
1.2 Symbols and markings ...........................................................................................4
2 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 ....................................................................................................10
4 Mode of operation ............................................................................ 11
5 Procedure during use ....................................................................... 12
5.1 Connection combinations .......................................................................................12
6 Assembly .......................................................................................... 13
7 Operation ......................................................................................... 14
7.1 Before use ..............................................................................................................14
7.2 Function test in the operating theatre ...................................................................14
7.3 During the operation ..............................................................................................15
7.4 Removal ..................................................................................................................16
7.5 After use .................................................................................................................17
7.5.1 Spare parts .....................................................................................................17
8 Dismantling ...................................................................................... 18
9 Pre-conditioning ............................................................................... 19
9.1 General information ...............................................................................................19
9.2 Device-specific information ....................................................................................19
9.3 Inspection ...............................................................................................................21
9.4 Packaging ...............................................................................................................22
10 Environmental conditions ............................................................... 22
10.1 Storage and transport ..........................................................................................22
11 Technical data ................................................................................. 23
12 Disposal .......................................................................................... 23
13 Symbols on packaging .................................................................... 24

Applying the instructions for use
4 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
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 section “Safety
instructions”, page 7) 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 products listed below:
1.2 Symbols and markings
Structure of warning notices:
REF
360 mm 460 mm Label
770-600 ERGOact, handle
770-610 770-620 ERGOact, shaft tube, Ø 5 mm
770-611 770-621 ERGOact, Maryland (insert)
770-612 770-622 ERGOact, Kelly (insert)
770-613 770-623 ERGOact, fenestrated (insert)
770-660 770-661 ERGOact, Maryland
770-662 770-663 ERGOact, Kelly
770-664 770-665 ERGOact, fenestrated
SIGNAL WORD
Type, source and consequences of the danger (personal injuries)!
Measure for avoiding the danger.

Applying the instructions for use
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 5
Danger levels in warning notices:
Tips:
Other symbols and markings:
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.
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

Purpose
6 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
2 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.

Safety instructions
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 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.
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 permitted voltage of the individual components must not be exceeded.
Respect with the recommended power settings and maximum voltage. Always
choose the lowest required power setting.
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.
• If necessary, use a suitable tester (e.g. 050-230) to check the device is in proper working
order.

Safety instructions
8 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
3.2 Use-related
• Make sure that the HF cable is correctly attached to the instrument and to the HF
generator by means of the correct connectors.
• 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 HF generators for additional
information on interference with other devices.

Safety instructions
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 9
• Do not repair or service defective devices:
Check the device for damage after reprocessing and before use.
CAUTION: A visual inspection alone is not sufficient for ensuring the integrity of the
insulation.
Replace and dispose of defective devices immediately.
Observe the instructions for use of the HF device and the general instructions for
electrosurgical operations!
• The "BF" / "CF" application part of the HF device used is extended by the instrument
connected to it.
• Electrical safety is improved through the use of plastic trocars.
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.

Safety instructions
10 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
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.

Mode of operation
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 11
4 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.

Procedure during use
12 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
5 Procedure during use
1. Sterilise the device, delivered in a non-sterile condition, before use.
2. Check the completeness of the individual parts and mount the instrument (see section
“Assembly”, page 13).
3. Attach the instrument to a connection cable suitable for the HF generator being used
(see “Connection combinations”, page 12). The use of BOWA connection cables is
recommended, since the plug connections of other manufacturers do not have to
comply with the technical standards.
4. Do not exceed the maximum permissible voltage.
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. Decontaminate the devices after use.
5.1 Connection combinations
Permissible connection combinations can be found in the BOWA declaration of
compatibility at www.bowa-medical.com.

Assembly
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 13
6 Assembly
Assemble the instrument in the following sequence:
1. Introduce the instrument into the shaft tube.
2. Take hold of the jaw and rotate anti-clockwise to tighten.
Shaft with insert is now ready to mount on the handle.
3. Introduce the shaft tube with insert into the completely opened handle until you here 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
14 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
7 Operation
7.1 Before use
The instrument is assembled, see section “Assembly”, page 13.
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 section
“Inspection”, page 21).
7.2 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.
WARNING
Risk of patient injury!
Use only compatible HF generators (see BOWA declaration of
compatibility).
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.

Operation
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 15
7.3 During the operation
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 rotation wheel (with the jaws open) to adjust the angle of the jaws.
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.
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.

Operation
16 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
3. Place the tissue to be sealed between the jaws.
4. Close the jaws to grasp the tissue.
Never grasp too much tissue.
The tissue is grasped and pinched.
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.
6. Release the actuated switch.
The tissue is coagulated.
The tissue has been grasped by the jaws and is coagulated.
7.4 Removal
1. Close the jaws by closing the handle.
2. Withdraw the instrument from the trocar sleeve.
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.
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.

Operation
BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact 17
7.5 After use
Prepare the laparoscopy instrument after use (see section “Pre-conditioning”,
page 19).
7.5.1 Spare parts
To order spare parts, contact your BOWA dealership or visit our website: www.bowa-
medical.com
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 19.
Inserts with damaged jaws must be replaced.

Dismantling
18 Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715
8 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 clockwise until it comes loose.
5. Pull the insert out of the shaft tube.
The instrument is now dismantled.
1.
2.
3.