Bowa ERGO 310D Manual de usuario
MN031-600-S2
Instructions for use
en
BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116
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Legend
Knife
Jaws
Shaft
Rotation wheel
Active electrodes
HF cable with COMFORT plug
Handle with operating lever
Trigger
Finger switch
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1 Intended use
1.1 Purpose:
The ERGO 310D is an instrument for vessel sealing arterial and
venous blood vessels and vascularized tissue in laparoscopic
and open surgery procedures in many different surgical
disciplines (including but not restricted to general surgery,
gynecology, urology, thoracic surgery, etc.).
The instrument can also be used for cutting through tissue.
The instrument is intended for use with the bipolar vessel
sealing mode of BOWA ARC generators.
1.2 Contraindications:
Vessel sealing instruments must not be used if, in the opinion of
an experienced physician or according to current medical
literature, their use would put the patient at risk, for example,
due to the patient’s general condition or if there are other
contraindications.
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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.
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2 General safety instructions
The HF device may be used only by trained medical staff. The
surgeon and medical staff must be trained in the fundamental
principles, rules for use and risks of HF surgery and must be
familiar with them.
Read the operating manual carefully and thoroughly before
using the device!
Use aseptic techniques when removing the product from
the packaging.
Do not use the product if the packaging is opened or
damaged, the product will no longer be sterile. Do not re-
sterilize!
The product is intended for single use and may not be
resterilized. While autoclaving, the instrument gets
thermally damaged, deformed so that it loses its function.
Do not use the product if its expiry date has elapsed.
Do not use defective instruments.
All serious incidents arising in connection with the product
must be reported to the manufacturer and the competent
authority of the member state in which the user is
established.
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2.1 HF device
Use only approved HF devices and programs (see section
8, page 16).
Observe the operating instructions of the HF device and
the general instructions for electrosurgical operations!
The “BF”/”CF” applied part of the HF unit used is extended
by the instrument connected thereto.
Improper use of HF current can lead to endogenous and
exogenous burns and explosions:
Avoid direct skin contact with HF cables.
Avoid contact with flammable gases and liquids.
2.2 HF cable
Improper use of HF cables can lead to patient injuries:
Never lay the HF cable on the patient’s skin.
When plugging or unplugging the HF cable, always grasp
the connector directly.
Use only HF cables that are in perfect condition. Never use
a defective HF cable.
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.
2.3 Active electrodes and instrument
Defective or worn electrodes can cause burns to the patient:
Never use or repair worn or defective electrode surfaces.
Dispose of them.
Hot electrode surfaces may cause patient injuries:
Maintain sufficient distance between the tips of the
instrument and sensitive tissue structures, such as the
pancreas or intestine.
Ensure that hot instruments are not used for preparation.
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Inadvertent activation of the ligation instrument may cause
patient injuries:
Do not lay the ligation instrument on the patient.
Dirty electrodes may cause a short circuit, thereby resulting in
functional failure of the ligation instrument.
Clean the jaw electrodes regularly with a moist cloth.
2.4 EMC Information
Medical electrical devices are subject to special EMC
precautions, so please observe the following directions.
BOWA accessories are intended only for connection to HF
devices specified by BOWA.
Use of the accessories on medical devices from
manufacturers other than those described may lead to
elevated emissions or reduced interference immunity.
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2.5 Personal safety instructions
Incorrect HF generator configuration settings and limited
visibility can lead to patient injuries:
Carry out operations only with adequate visibility.
Use only the ligation program of BOWA ARC generators
with bipolar ligation current.
Prepare the tissue to be sealed so it is as free as possible
in order to avoid unintentional clamping.
Skin-to-skin contact (e.g. between the arms and body of
the patient) should be avoided, e.g. by placing dry
compresses between possible contact points.
2.6 Patients with pacemakers
Malfunctions or destruction of the pacemaker can endanger the
life of the patient or result in irreversible injuries to the patient:
Never perform ambulant operations on patients with
pacemakers.
In cases of patients with pacemakers, consult the
cardiologist before carrying out HF surgery.
NOTE
Combining medical devices is only safe if
the relevant instructions for use permit the desired
combination or
the purpose and the interface specification of the
products used in combination allow this.
The instructions for use and the interface specification
of the medical devices used in combination must be
strictly observed.
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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.
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