3
2.1
PRECAUTIONS
2.1.1
General
2.1.1.1
Electrical shock hazard. Do not remove cover. Refer to authorized
personnel for service.
2.1.1.2
Surgitron
®
Dual/EMC may present a hazard to patients with
pacemakers. Consult qualified medical personnel.
2.1.1.3
The manufacturer-supplied accessories should be used to ensure the
proper operation of safety monitoring circuit.
2.1.1.4
If higher than normal power settings are required, examine all cables,
handpieces and the neutral plate for damage and confirm that cables are
not wrapped around metal objects or touching the floor. In the event that
higher power is still required, replace the neutral plate and handpieces.
2.1.1.5
WARNING: No modification of this equipment is
allowed.
2.1.1.6
The patient should not come into contact with metal parts which are
earthed or which have appreciable capacitance to earth. The use of
antistatic sheeting is recommended for this purpose.
2.1.1.7
Physician to patient skin to skin contact should be avoided. Use of
insulating gloves is recommended. Patient skin-to-skin contact (eg,
between the arms and body of the patient) should be avoided (eg, by
insertion of dry gauze).
2.1.1.8
When used simultaneously with physiological monitoring equipment, the
monitoring electrodes on the patient should be placed as far as possible from
the surgical electrodes. Do not use metal needle monitoring electrodes or
EKG clip electrodes as burns may occur. Monitoring systems incorporating
high-frequency current-limiting devices are recommended.
2.1.1.9
The cables to the surgical electrodes should be positioned in such a way
that contact with the patient or other leads is avoided. Temporarily
unused active electrodes should be stored segregated from the patient.
2.1.1.10 The output power selected should be as low as possible for the
intended purpose.
2.1.1.11 Apparent low output or failure of the surgical equipment to function
correctly at the normal operating settings may indicate faulty
application of the neutral plate or poor contact in its connection.
2.1.1.12 Before each use inspect the accessories, electrode cables
and probes for possible physical damage.
2.1.1.13 Do not obstruct air circulation vents on the rear or underside of
the generator.
2.1.1.14 Surgical gloves should be worn to prevent the User from
becoming a part of the RF energy return pathway.
2.1.1.15 Use caution when treating subjects with metal implants. Metal implants in
the electrical pathway (between the neutral plate and electrode) have the
capacity to conduct energy and/or become warm.
2.1.1.16 High frequency surgical equipment output from either active
electrode may change when operating mode is changed.
2.1.1.17 Select associated equipment and active accessories that have rated
accessory voltages equal to or greater than the maximum output voltage.
Avoid high frequency voltage settings where maximum output voltage may
exceed rated accessory voltage.
2.1.1.18 For surgical procedures where the high frequency current could flow
through parts of the body having a relatively small cross-sectional area,
the use of bipolar techniques may be desirable to avoid unwanted
coagulation.
2.1.1.19 Similar to all energy sources, by-products such as tissue smoke plume
and aerosols, create a health concern about their carcinogenic and
infectious potential. Appropriate protective measures including effective
smoke evacuation should always be utilized.
