Bowa ERGO 315R User manual

MN031-554-S0 en
Instruction for use

Key
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Key
Sterile blade
Blade rod
Push rod
Jaw
Slotted ring for blade
rod latching
Spring latch
Mounting marking
Blade holder
Grip area
Blade
Blade holder
Teeth
Electrodes

Key
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Handle
Cable with handswitch
Pushbuttons
Rotation wheel
Locking knob
Mounting
marking
Blade trigger
Jaw holder
Jaw actuation lever
Handswitch
Connector for
BOWA ARC
generator

Key
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Cleaning adapter
Cleaning brush
Reprocessing basket & lid
Cleaning adapter for
push rod
Cleaning adapter for
jaw / handle

Contents
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Contents
Key .......................................................................................................2
Contents .................................................................................................5
1Using this operating manual ......................................................7
1.1 Scope of validity ............................................................................7
1.2 Symbols and notation....................................................................8
2Intended use ................................................................................9
2.1 Indications......................................................................................9
2.2 Contraindications...........................................................................9
3Safety..........................................................................................10
3.1 HF device.....................................................................................10
3.2 HF cable ......................................................................................10
3.3 Replaceable blade in blade holder..............................................10
3.4 Repair and service.......................................................................10
3.5 Patients with pacemakers............................................................11
3.6 EMC instructions .........................................................................11
4Mode of operation .....................................................................12
5Assembly....................................................................................13
5.1 Mounting the blade with the blade holder....................................13
5.2 Assembling the vessel sealing instrument ..................................15
6Operation....................................................................................21
6.1 Before use ...................................................................................21
6.2 Function test in the OR................................................................21
6.3 During the operation....................................................................22
6.4 Withdrawal...................................................................................24
6.5 After use ......................................................................................24

Contents
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7Dismantling................................................................................25
7.1 Dismantling the vessel sealing instrument..................................25
7.2 Disassembley..............................................................................26
7.3 Remove the blade .......................................................................28
8Cleaning......................................................................................29
8.1 Dismantling..................................................................................30
8.2 Soaking........................................................................................30
8.3 Manual removal of contamination ...............................................31
8.4 Pretreatment in an ultrasonic bath ..............................................32
8.5 Automatic preparation in a CDM .................................................33
8.5.1 Preparation for automatic cleaning –cleaning adapter...............33
8.5.2 Placing the parts in the cleaning and reprocessing basket.........35
8.6 Inspection ....................................................................................37
8.7 Packing........................................................................................39
8.8 Autoclaving..................................................................................39
8.9 Recommended operating supplies..............................................40
9Storage .......................................................................................41
10 Transport....................................................................................41
11 Technical specifications...........................................................42
12 Disposal......................................................................................42
13 Symbols on packaging .............................................................43

1 Using this operating manual
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1 Using this operating manual
This operating manual is part of the product.
BOWA-electronic GmbH & Co. KG assumes no liability and provides no
warranty whatsoever for any damage or consequential damage arising
from non-compliance with this operating manual.
Read the operating manual, in particular the safety instructions
(see section 3, page 10) carefully and thoroughly before use.
Store the operating manual in a safe place throughout the
service life of the device.
Keep the operating manual accessible to operating theatre
personnel.
Give the operating manual to each successive owner and/or
user of this device.
Always update the operating manual whenever you receive
additional information from the manufacturer.
1.1 Scope of validity
This operating manual applies only to the parts of the instrument
ERGO 315R listed below.
REF
Name
770-510
ERGO 315R Handle
770-522
ERGO 315R Jaw 275 mm
770-523
ERGO 315R Jaw 360 mm
770-532
ERGO 315R Push rod 275 mm
770-533
ERGO 315R Push rod 360 mm
770-542
ERGO 315R Blade rod 275 mm
770-543
ERGO 315R Blade rod 360 mm
770-998
ERGO 315R Blade sterile (10 Pcs.)
358-245
ERGO 315R Cable with handswitch
723-050
ERGO 315R Cleaning adapter set
773-982
ERGO 315R Reprocessing basket
773-983
ERGO 315R Lid for basket
723-000
Cleaning brush set

1 Using this operating manual
8 BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103
1.2 Symbols and notation
Structure of warning instructions
SIGNAL WORD
Type, source and consequences of the hazard
Measure for avoiding the hazard.
Hazard levels of warning instructions
Symbol
Hazard level
Probably of
occurrence
Consequences of
non-compliance
DANGER
Immediate risk
Death or serious
injuries
WARNING
Possible risk
Death or serious
injuries
CAUTION
Possible risk
Minor injuries
NOTE
Possible risk
Property damage
Tips
Tips to make your work easier or supplementary explanatory
information for a procedure.
Other symbols and notation
Symbol or notation
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
..., see section xxx, page xxx
Cross-reference

2 Intended use
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2 Intended use
2.1 Indications
The ERGO 315R instrument is intended to be used to seal arterial and
venous blood vessels and vascular tissue structures in laparoscopic and
open surgical procedures in varied surgical disciplines (including but not
limited to general surgery, gynecology, urology, thoracic surgery and
other).
The instrument can also be used to cut tissue.
The ERGO 315R instrument is intended to be used with the bipolar vessel
sealing operating mode of BOWA ARC generators.
2.2 Contraindications
Do not use vessel sealing instruments if, in the opinion of an experienced
physician or according to current professional literature, such use would
cause endangerment of the patient due, for example, to the general
condition of the patient, or if other contra-indications are present.
WARNING
Risk of patient injury
Do not use with vessels larger than 7.0 mm in diameter.
The reliability of sealing must be assessed by the attending
physician according to the nature of the vascularised tissue
and the vessel pathology (arteriosclerosis, aneurysms,
vascularisation, etc.).
Do not use on the heart, on the central circulatory system
or on the central nervous system.
Do not use for contraceptive coagulation of the Fallopian
tubes.
Do not use vessel sealing for tissue groups with unknown
content.
Proceed cautiously when performing sealing in the vicinity
of sensitive structures, such as nerves or ureter.
Avoid grasping too much tissue for sealing –the jaws
should not be full.

3 Safety
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3 Safety
It is not necessary to use a neutral electrode with bipolar
ligation instruments.
The instrument may only be used by trained medical staff. The surgeon
and the medical technicians must be trained in and familiar with the
fundamentals, codes of practice, and risks of HF surgery.
Read the operating manual carefully and thoroughly before
using the device.
All serious incidents occurring in connection with the product
must be reported to the manufacturer and to the competent
authority of the country in which the user is established.
3.1 HF device
Observe the operating instructions 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.
3.2 HF cable
Improper use of HF cables can lead to patient injuries:
When plugging or unplugging the HF cable, always grasp the
connector directly.
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 operating manuals of the BOWA HF generators for
additional information on interference with other devices.
3.3 Replaceable blade in blade holder
Do not recondition the replaceable blade and blade holder.
Discard and replace used blades and blade holders.
3.4 Repair and service
Do not repair or service defective devices.
Discard or replace defective devices.

3 Safety
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3.5 Patients with pacemakers
Malfunction or destruction of the pacemaker can endanger the life of the
patient or result in irreversible injuries to the patient.
3.6 EMC instructions
Medical electrical devices are subject to special precautionary measures
with regard to EMC. Observe the following 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.
DANGER
Risk of patient injury
Never perform ambulant operations on patients with
pacemakers.
In cases of patients with pacemakers, consult the
cardiologist before carrying out HF surgery.
Set the demand pacemaker to a fixed frequency.
Ensure that the pacemaker does not come into contact with
the HF electrode.
Keep a fully operational defibrillator within reach.
Carry out a postoperative pacemaker check.
NOTE
With combinations of medical devices, safety can only be
assured if:
the desired combination is allowed by the relevant
operating manuals
using the devices in the desired combination complies with
the intended use and the interface specification.
Strict attention must be given to the operating manuals and
interface specifications of medical devices used in
combination.

4 Mode of operation
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4 Mode of operation
In bipolar HF surgery, tissue coagulation is achieved by applying a high-
frequency AC current, which generates heat.
The ERGO 315R vessel sealing instruments are invasive surgical
instruments for use in laparoscopic or open surgery. They are used
through surgically produced access openings in conjunction with devices
for endoscopic use, such as trocars and optics.
The active electrodes are the non-insulated areas of the jaws. The HF
current flows from one electrode of the instrument through the biological
tissue to the other electrode to produce the desired localized tissue effect.
With this method, sealing of a vessel or tissue segment carrying blood is
achieved by HF current in combination with supplementary pressure. The
sealed location is haemostatically tight with respect to systolic blood
pressure and permanently closed.
The instrument can be used for vessels with diameters up to 7 mm.
The integrated cutting function of the ERGO 315R allows the tissue to be
cut under treatment immediately after sealing without first changing
instruments.
The electrodes can be opened, closed and latched by actuating the handle.
A ratchet mechanism in the handle generates a reproducible mechanical
pressure on the electrode tips when the handle is closed. The jaw can be
rotated and positioned by a rotation wheel on the handle.

5 Assembly
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5 Assembly
5.1 Mounting the blade with the blade holder
CAUTION
Risk of injury from sharp blade
To avoid punctures and lacerations, always use the blade
holder or a suitable aid for blade assembly
The blade and blade holder are supplied sterilized.
1. Remove the blade and blade holder from the sterile package.
2. To mount the blade, grasp the blade holder in the grip area.
Position the blade rod on the blade holder as indicated by the
markings on the blade holder and slide the blade rod in the
direction indicated by the arrow until the blade clicks into place.

5 Assembly
14 BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103
3. Lift the blade rod with the mounted blade slightly and pull it out
of the blade holder. Discard the blade holder.
Avoid bending the blade in the process.
4. Visually check the blade for correct assembly.

5 Assembly
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5.2 Assembling the vessel sealing instrument
Assemble the vessel sealing instrument in the sequence shown below.

5 Assembly
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Insert the blade rod into the push rod
Insert the blade rod with the assembled blade into the push rod.
Align the spring latch of the blade rod with the slotted ring of the
push rod and insert the blade rod until it clicks in place.

5 Assembly
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Insert the push rod into the jaw
Insert the push rod with the assembled blade rod into the
completely opened jaw.
Align the teeth of the push rod with the orange marking on the
jaw.

5 Assembly
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Mount the jaw on the handle
Assemble the jaw and handle.
1. Close the jaws with your fingers and guide the jaw into the
handle until it latches with a click.
Ensure that the orange marking on the handle is aligned with
the marking on the jaw.

5 Assembly
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2. Continue holding the jaws closed with your fingers and slide the
lever of the handle forward until it also latches with a click.
3. Check the vessel sealing instrument for proper opening,
gripping and latching by actuating the handle.
4. Check the blade for ease of motion by actuating the blade
trigger.
5. Unlatch the jaws by again actuating the handle.
6. Check whether the rotation wheel can be turned when the
handle is unlocked.

5 Assembly
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Attach the cable with the handswitch
1. Attach the connection cable by inserting the handswitch in the
handle.
2. Clamp the cable in the guide groove of the handle.
The handswitch can be operated from either side, making it
suitable for both left-handed and right-handed use.