Baylis RFP-100A - PRECAUTIONS

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• Skin-to-skin contact (for example between the arms and body of the patient) should be

avoided, for example by insertion of dry gauze.

• During RF output, implanted devices such as pacemakers may be affected. Qualified

advice should be obtained as necessary, to minimize the risk from injury due to implanted

device malfunction.

• Unless a compatible monitoring return electrode that meets or exceeds IEC 60601-2-

2:2017 is used with the contact quality monitor, loss of safe contact between the return

electrode and patient will not result in an auditory alarm.

• The Generator should not be operated if the display area (LCD screen) is cracked or broken.

• Devices should not be used in the presence of flammable materials, chemicals, and

substances (anesthetics, oxygen, etc).

• No modification of Generator is allowed. Modification may result in patient or operator

harm.

• Flammable solutions may pool under the patients or in body depressions such as the

umbilicus, and in body cavities such as the vagina.

• Generator failure can lead to neuromuscluar stimulation.

• When using RF On/Off switch, the Generator can deliver RF energy without continous

depression of RF On/Off switch for the specified treatment time. Failure to specify correct

treatment time could result in an unintended RF delivery.

3.2. PRECAUTIONS

• The Generator is intended for use with separately cleared BMC RF Devices, BMC

connector cables and an optional accessory footswitch only. Ensure that the rated accessory

voltage is equal to or greater than the Generator’s maximum output voltage.

• Ensure that the Generator connector cables and dispersive electrode cables are positioned

in such a way that contact with the patient or other leads is avoided.

• Ensure the application and connections of dispersive electrode before selecting a higher

output setting on generator.

• Temporarily unused Devices should be disconnected from the Generator, from the

Connector Cable or they should be stored in a location that is isolated from the patient.

• It is recommended not to exceed the specified number of RF energy applications per BMC

RF Device, as indicated within the BMC RF Device’s specific instructions for use.