2 Intended Purpose
BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219
9
2.
Intended Purpose
Electrosurgical equipment for cutting and coagulation of tissue.
2.1.
Indications
The vessel sealing/ligation instrument is intended to be used to seal arterial
and venous blood vessels and vascular tissue structures in laparoscopic
and open surgical procedures in various surgical disciplines (including but
not limited to general surgery, gynaecology, urology, thoracic surgery and
others). The instrument can also be used to cut tissue.
2.2.
Contraindications
Vessel sealing/ligation instruments must not be used in direct contact with
the heart, central nervous system or central circulatory system.
Do not use vessel sealing/ligation instruments if their surgical techniques
are contraindicated.
Do not use vessel sealing/ligation instruments if, in the opinion of an
experienced physician or according to current specialist literature, such use
would endanger the patient, f
or example due to the patient’s general
condition, or if other contraindications are present.
3.
Safety instructions
3.1.
Device-related
•
The instrument may only be used by trained medical staff. The surgeon
and the medical specialist personnel must be trained in, and be familiar
with, the fundamentals, 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.
•
Do not reprocess the replaceable blade and blade holder.
Risk of injury from sharp blade
Discard and replace used blades and blade holders.
•
The device must not be operated in AUTOSTART mode.
•
As part of your responsibility for the sterility of the instruments used,
please note:
Содержание ERGO 315R
Страница 1: ...MN031 554 S3 en Instructions for use...
Страница 47: ......