Bowa ERGOeco, Instructions For Use Manual

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Safety instructions
8 Instructions for Use ERGOeco BOWA-IFU-13120-ERGOECO-S0-EN-20220420
3 Safety instructions
3.1 Device-related
•
The instrument may only be used by trained medical staff. The surgeon and the medical
professionals must be trained in, and hence be familiar with, the fundamental principles,
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 user’s country of residence.
•
The devices are supplied in non-sterile condition and must be cleaned and sterilised
before use.
•
Risk of injury from sharp edges.
•
The device must not be operated in AUTOSTART mode.
•
You are responsible for ensuring the instruments are sterile
•
Please comply with the following:

Always clean and sterilise the handle and the corresponding insert
before each use (see chapter 9 “Reprocessing”).

Only use cleaning, disinfection and sterilisation methods that have been validated for
the specific devices and products concerned.

Comply with the validated parameters for each cycle.

Comply with the legal regulations applicable in your country, as well as the
hygiene regulations of the hospital.

Do not use gas sterilisation or hot air sterilisation as these methods can damage the
device.
•
To avoid burns (thermal overload), please comply with the following:

Make sure that all electrical plug connections are correctly seated.

Do not strain the devices beyond their mechanical limits
(e.g. by excessively bending, kinking, or crushing them or by running them over with
an instrument trolley).

The maximum rated voltage of the instrument must not be exceeded (see chapter 11
“Technical data”).

Comply with the recommended power settings and maximum voltage of the
designated HF generator.
The effectiveness of the settings must be assessed by the user.
•
In order to rule out the risk of injuries and electric shocks for the patient and the operating
personnel, make sure that the power supply is switched off before connecting the HF
connection cable and accessories to and removing them from the electrosurgical device.
•
Cables must never be inserted or removed while the device is activated.
•
Do not repair or service defective devices:

Check the device for damage, in particular for the integrity of the insulation, after
reprocessing and before use.

Replace and dispose of defective devices immediately.