IEC TR 61289:2011 pdf – High frequency surgical equipment – Operation and maintenance.
– Be aware of electromagnetic interference during use which may influence other MEDICAL ELECTRICAL EQuIPMENT, for example ECG monitors, blood pressure monitors, infusion pumps, cardiac pacemakers, etc.
6 Recommended practices after use
After each use, the HF SURGICAL EQUIPMENt should be cleaned as indicated in the instructions for use. Reusable ACTIVE ACCESSORIES should be cleaned and sterilized according to local policy and the manufacturer’s recommendations. Any irregularities observed during surgery should be documented and reported to the proper hospital authorities.
7 Nature of HAZARDS
7.1 General
The currents and voltages generated in HF SURGICAL EQUIPMENT may present a HAZARD to the patient or the OPERATOR by the nature of its use or by its electrical interference with other equipment in the vicinity of. in contact with, or implanted within the patient. The generation of sparks or arcs between the ACTIVE ELECTRODE and tissue o, for example, a metal forceps may be a source of low frequency components in the output current which may cause neuromuscular stimulation (or electric shock).
The following subclauses give some examples of HAZARDS that are associated with the use of
7.2.1 Incompatible combinations
Although it may be possible to physically connect different pieces of HF SURGICAL EQUIPMENT. the Combination may not always work in the expected manner. OPERATORS Should always confirm the compatibility of different pieces of HF SURGICAL EQUIPMENT with all of the manufacturers involved. This includes correct operation. possible changes in the electromagnetic compatibility of the combination, and electrical safety. For example. Identical looking footswltches from different manufacturers may not be electrically Identical resulting in unexpected, unintended and potentially harmful results.
7.2.2 Electromagnetic compatibility
When in use. HF SURGICAL EQUIPMENT will generate electromagnetic disturbances. A disturbance may be radiated through the air, conducted through the patient or conducted through the mains power cord. This may impact other MEDICAL ELECTRICAL EQUIPMENT in the vicinity of or connected to the patient. OPERATORS should follow the recommendations of the manufacturer(s) regarding this situation. This includes the manufacturer of any active implanted, body worn, or semi-implanted device. There may be techniques for cable placement, equipment setup and/or output mode/power setting that will help mitigate this
7.2.3 Misconnection of ACTIVE ACCESSORIES
Some ACTIVE ACCESSORIES may be physically connected to HF SURGICAL EQUIPMENT in a manner not intended by the manufacturer. An example might be a BIPOLAR ACTIVE ACCESSORY incorrectly connected to a MONOPOLAR receptacle through the use of an adapter or nonconforming cord. OPERATORS should always consult the instructions for use for the correct connection information.
Certain types of specialty HF SURGICAL EQUIPMENT may have risks associated with their use that are different from traditional HF SURGICAL. EQUIPMENT. These risks may not be obvious. The instructions for use will list the warnings and cautions particular to that HF SURGICAL EQUIPMENT. An example is argon-enhanced HF SURGICAL EQUIPMENT where the risks associated with the use of argon gas should be understood by the OPERATOR.
7.3.1 Incompatible combinations
An ACTIVE ACCESSORY may not be compatible with every cord that can be physically connected to It. The Incompatibility may be electrical where the voltage andlor current that will be used Is too high. The Incompatibility may be In the physical connection itself where the mating parts are not of the same size or tolerance, potentially causing the connection to become hot or come apart during surgery. The connection may be incomplete with uncovered bare metal allowing stray current to injure the patient or OPERATOR.
An ACTIVE ACCESSORY may not be compatible with every ACTIVE ELECTRODE that can be physically connected to It. The Incompatibilities and the consequences are likely to be the same as described above.
An ACTIVE ACCESSORY may not be compatible with every output mode, power or voltage to which it could be exposed. OPERATORS should consult the instructions for use of both the ACCESSORY and the HF SURGICAL EQUIPMENT for compatibility information and maximum voltage ratings. An output mode or power setting that delivers a peak voltage greater than the maximum peak voltage rating of an ACTIVE ACCESSORY Is an example of this HAZARD and should be avoided. The maximum peak voltage rating is also known as the RATED ACCESSORY VOLTAGE within IEC 60601-2-2.
7.3.2 Environment of use
Sparks generated at the ACTIVE ELECTRODE during normal use may cause a fire If flammable anaesthetic or cleaning agents are present or the HF SURGICAL EQUIPMENT is used in an atmosphere enriched by endogenous gases, oxygen or nitrous oxide.