STARmed EUSRA RF 18G Benutzerhandbuch Seite 2

User's Manual
1. Introduction
The electrode for this electrosurgical device is used
by connecting it to the RF lesion generator from
STARmed Co., Ltd. which was designed to coagulate
tissues.
The electrode, in combination with an endoscopic
ultrasound (EUS) or scope, is used to access body
cavities in order to coagulate tissues. Tissues can be
coagulated with the supply of radiofrequency energy
from the electric cautery, which is connected to the
generator for monitoring
temperature of tissues.
The electrode's fixed insertion length can be adjusted
by the screw on the handle from 0 cm to 8 cm (1 cm
units).
The 19G Model electrode legnth can be adjusted from
1 cm to 5 cm by the controller which adjusts the len
gth of endoscope.
2. Guide for Use
Read all of the following information and also the
provided user's generator guide before use.
The EUSRA RF Electrode is designed to be used in
conjunction with the RF lesion generator from
STARmed Co., Ltd. If the guidelines are not properly
followed, damages can be caused from electricity or
heat and the equipment may malfunction.
3. Intended Purpose
Sterile single-use RF
intended for coagulation of tissue during endoscopic,
percutaneous, laparoscopic,
surgical procedures.
4. Contraindications
Sterile single-use RF
STARmed Co., Ltd.
Electrode for electrosurgical device
[EUSRA RF Electrode]
the impedance
coagulation electrode is
and intraoperative
coagulation electrode
contraindicated for use in patients with Implantable
Pacemakers and Automatic Implantable
Cardioverter/Defibrillators (AICDs), as they may be
adversely affected by radiofrequency (RF) current.
5. Intended patient population
age
weight
gender
health
and
Nationality
Patient state
Contraindication
group
WARRANTY
STARmed Co., Ltd. warrants sufficient care for the
design and manufacture of this device. We do not
warrant any content that is not described in this
manual. The handling, storage, and operation of the
EUSRA RF Electrode beyond what is described in the
IFU may directly affect the results obtained from its
use.
STARmed's device under this warranty is limited to
repair and replacement, and STARmed Co., Ltd is not
responsible for any economic expenditures caused by
unexpected issues, significant loss, or damage.
STARmed Co., Ltd. is not transferring responsibility
and duty related to this device to other parties, and
will not take any responsibility regarding reuse and
usage of re-sterilized or expired products.
6. Warning
- Before using this product, check whether there is
any damage to the packaging.
is
- 1 -
Newborn to geriatric
>2.5Kg
Male and Female
Use for patients with liver cancer,
thyroid cancer, lung cancer, kidney
cancer or other lesions.
Multiple
The patient is not the device user. Not
relevant unless the patient is agitated.
Patients with implantable pacemaker
and implantable
cardioverter/defibrillators.
ST-UM-28CE(Rev.8)