14
User Manual
Operator regulation
The device unit is classified as medical device unit class IIb (Europe).
Technical controls:
The user is committed to perform on a regular basis technical controls after the following specifications:
Period: every 24 months, starting with date of delivery and after each repair.
1. During operation, a minimum distance of c. 20 cm from any walls must be kept.
2. The NEUTRAL ELECTRODE should be reliably stuck to a correspondingly prepared suitable area of the PATIENT body with its
entire surface, as defined by the PRODUCER.3. The PATIENT should not get in touch with any metal parts that are grounded or
have a significant earth capacitance (e.g. operating table supports etc.).
3. The PATIENT should not get in touch with any metal parts that are grounded or have a significant earth capacitance (e.g. operating
table supports etc.).
4. Skin-to-skin contacts (e.g. between the arms and the body of the PATIENT) should be avoided, e.g. by inserting dry gauze. The cable
leading to the hf Surg device should neither touch the patient nor any other lines. Instruments which are temporarily not 1. During
operation, a minimum distance of c. 20 cm from any walls must be kept.
2. The NEUTRAL ELECTRODE should be reliably stuck to a correspondingly prepared suitable area of the PATIENT body with its
entire surface, as defined by the PRODUCER.3. The PATIENT should not get in touch with any metal parts that are grounded or
have a significant earth capacitance (e.g. operating table supports etc.).
3. The PATIENT should not get in touch with any metal parts that are grounded or have a significant earth capacitance (e.g. operating
table supports etc.).
4. Skin-to-skin contacts (e.g. between the arms and the body of the PATIENT) should be avoided, e.g. by inserting dry gauze. The cable
leading to the hf Surg device should neither touch the patient nor any other lines. Instruments which are temporarily not in use during
the treatment have to be kept away from the patient, e.g. on the instrument table.
5. The output power should be set as low as possible for the corresponding purpose.
6. An obviously low output value or functional failure of the hf Surg device in usual operation can be caused by insufficient adherence
of the NEUTRAL ELECTRODE or insufficient contact in its connections. In such case, the adherence of the NEUTRAL ELECTRODE
and its connections should be checked before setting a higher output power.
7. The use of ignitable anesthetic agents or combustible gases like nitrous oxide (N20) and oxygen should be avoided if a surgical inter-
vention is executed in the head area, unless these substances are aspirated. If possible, non-ignitable ingredients should be used for
cleaning and disinfection. Ignitable ingredients used as cleaning and disinfection agents or as solvents for adhesives should have
evaporated before the use of the hf Surgery.
8. For patients with pacemakers or other active implants, there is a potential DANGER of disturbance of the pacemaker function or
damage to the pacemaker. In case of doubt, an expert should be consulted.
9. The accessories must have a minimum accessory reference voltage of 500 V. Only use the original accessories contained in the delivery
and offered by the producer to achieve maximum safety for the patient and the caregiver. The characteristics of the applied parts and
conducts are adapted to the output power and output voltage of the device, so that a safe operation is ensured for all operation modes
and settings.
10. The device must be disconnected from the power supply during cleaning.
11. Service and maintenance tasks may only be executed by authorized specialized personnel.
12. The radiation emitted by the hf Surg device during operation can interfere with the functionality of other electric devices. Computers,
laptops and mobile phones should be kept away from the hf Surg device. Data on computers and laptops should be saved beforehand.
13. If any safety provisions and operating instructions contained in this manual are violated, any warranty and liability of the manufac-
turer is cancelled.
14. In operating rooms, the device may only be used with pedal switches with AP labeling.
