STARmed EUSRA RF 18G Benutzerhandbuch Seite 3

- The expiration date is three (3) years from the
sterilization date. Use of the products after the
expiration date is prohibited.
- This device is disposable and reuse is prohibited.
- This device is designed to be used by a qualified
and trained medical doctor.
- This device should be stored in a cool place without
sunlight and humidity.
- Do not touch the electrode's active tip while the
power supply is on.
- Do not touch the shaft of the electrode with fingers
or other tools (insulator and components are made
of metallic).
- Do not touch the electrode's hand piece/cable with
metallic materials. Touching the cable with metallic
materials may cause the patient or operator to get
shocked, cause a fire, or have an accident with
injury.
- Do not use on patients with cardiac pacemakers or
other active implants
- Do not use near conductive materials.
- Like all other electrosurgical devices, do not use in
the presence of flammable anesthetics, nitrous oxide
or any other flammable substances. Doing this may
cause a fire in the electrosurgical device.
- Flammable gases or other materials with a high risk
of flammability should be prohibited from being
placed nearby the RF generator. If a flammable
detergent has been used for cleaning or disinfection,
the liquid should be evaporated before the start of
the procedure.
- Cloth and guaze soaked in oxygen can possibly be
ignited from sparks which occur from normal use of
the device. Please use with caution.
- Do not activate the electrode while it is touching
any metallic substances or tools. Doing this may
cause an unexpected injury to the patient or
operator.
STARmed Co., Ltd.
Electrode for electrosurgical device
[EUSRA RF Electrode]
- Do not touch metals or tools with the electrode
while the power supply is on. Doing this may cause
an unexpected injury to the patient or operator
and/or damage to the electrode or other devices.
- When using the electrode, do not hold the tip of
the electrode by forceps, do not pass the electrode
through a hole of other devices, and do not scratch
the surface on the electrode's tip by sharp objects.
These actions might destroy the insulation of the
electrode and/or damage the electrode. It might
cause unexpected injury to the patient or the user.
- Do not access the lesion without proper imaging
guidance. It might cause an unexpected injury to the
patient and/or damage to the electrode.
7. Potential Complications
- Burning by overheating of the surgical device
- Dangers from an inexperienced operator's use
- Side effects or cross infection from reuse
- Weakness of liver functions
- Delayed bleeding in the operated body parts
- Recurrence of cancer
- Perforation
- Respiratory depression or arrest
- Symptoms after RFA treatment including:
abdominal pain, fever, nausea, headache, right
shoulder joint pain, and chest discomfort
The potential complications are not limited to the list
above. Other complications may occur.
8. Before Use
(1) Preparation of coolant
- The temperature of the coolant should be
maintained at almost 0℃ by keeping the IV bag in
the refrigerator for four (4) or more hours before the
procedure. It should be used just before performing
the procedure.
- 2 -
ST-UM-28CE(Rev.8)