Directed Electronics 1500X User's Guide download pdf (Page 7)

AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual

160-103990 Rev 03 Page 5

• Cables connected to the RITA



Device should not contact the patient or other

electrical leads.

• Skin-to-skin contact, such as between the torso and the arms, or between the legs of

the patient should be avoided by insulating these contacts with sheets or dry towels.

• Failure of high frequency surgical equipment could result in an unintended increase

of output power.

• When not in use electrosurgical leads (active or return) should be positioned so that

they cannot come into contact with the patient or other leads.

• High power settings can cause local desiccation of tissue, which can impede the

ability to produce expected ablations. Set power as low as possible for intended

purpose. Follow manufacturer’s guidelines of time at temperature for ablation

generation. If the recommended times and temperatures are not achieved at full

deployment of the Electrosurgical Device array, there can be no assurance that the

desired ablation volume has been created. Standard evaluative techniques, e.g., CT

or MRI, should be used to determine the actual extent of the ablation.

• If the device is being used in a laparoscopic procedure, care must be taken to avoid

a gas embolism.

• If the device is being used in a laparoscopic procedure, activation of the device when

not in contact with target tissue may cause capacitive coupling.

• If the RF Generator shuts down for a ThermoPad over temperature error or if the

generator is shut off or rebooted for any reason, the ThermoPads must be replaced

and moved at least 4cm from their original location.

3.4 Warnings and Precautions Specific to the RITA







System

• Electric shock hazard. Do not remove the cover of the RF Generator. Refer all

service to AngioDynamics, Inc. There are no user-serviceable parts inside the RF

Generator. Warranty will be voided if the unit is opened and/or the warranty

seal is broken.

• Only use metal introducers that have insulation. RF energy can be transmitted from

the electrode through the un-insulated metal introducer to the patient causing

inadvertent burns.

• Low power output or failure of the electrosurgical equipment to function correctly at

normal settings may indicate faulty application of the Dispersive Electrode or failure

of an electrical lead. Do not increase power output before checking for obvious

defects or misapplication. For monopolar surgery, effective contact between the

patient and the Dispersive Electrode must be verified whenever the patient is

repositioned.

• Although accessories may have similar connector types, potentially hazardous

conditions may exist when inappropriate accessories are combined, and may cause

harm to the patient, user, or Generator. Therefore, it is essential that ONLY RITA



Electrosurgical Devices and accessories are used with RITA



RF Generators, and

there is proper connection between them.

• Reusable accessory cables should be periodically tested for function and safety in

accordance with the cable’s instructions.

• The use and proper placement of a Dispersive Electrode is a key element in the safe

and effective use of monopolar electrosurgery, particularly in the prevention of burns.

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