IEC TR 61289:2019 pdf download

IEC TR 61289:2019 pdf download.High frequency surgical equipment and high frequency surgical accessories – Operation and maintenance
1 Scope
This document contains guidelines for medical and nursing personnel regarding the safe and effective operation of HIGH FREQUENCY SURGICAL EQUIPMENT and HIGH FREQUENCY SURGICAL ACCESSORIES (also referred to as HF SURGICAL EQUIPMENT in this document). It is also of use to scientific/technical staff who have responsibility for the maintenance of this equipment. The application guidelines in this document deal with the safe operation of HIGH FREQUENCY SURGICAL EQUIPMENT constructed according to the safety requirements of IEC 60601 -1 [1 ] 1 and IEC 60601 -2-2 [4]. Not all existing HIGH FREQUENCY SURGICAL EQUIPMENT meets the minimum requirements of current international standards, however, the guidelines in this document is still helpful in utilizing these devices.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.3.3 ACTIVE CONNECTOR part of an ACTIVE ACCESSORY intended for connection to an ACTIVE OUTPUT TERMINAL , which may include additional terminals for connection of a FINGERSWITCH to a SWITCH SENSOR [SOURCE: IEC 60601 -2-2:201 7, 201 .3.202] 3.4 ACTIVE ELECTRODE part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site and intended to pass HF current into body tissue [SOURCE: IEC 60601 -2-2:201 7, 201 .3.203] 3.5 ACTIVE HANDLE part of an ACTIVE ACCESSORY intended to be held by the OPERATOR [SOURCE: IEC 60601 -2-2:201 7, 201 .3.205] 3.6 ACTIVE OUTPUT TERMINAL part of HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an ACTIVE ACCESSORY and for delivery of HF current thereto [SOURCE: IEC 60601 -2-2:201 7, 201 .3.206, modified – The notes have been deleted.] 3.7 APPLIED PART part of ME EQUIPMENT that in normal use necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function [SOURCE: IEC 60601 -1 :2005, 3.8, modified – The notes have been deleted.] 3.8 ASSOCIATED EQUIPMENT MEDICAL ELECTRICAL EQUIPMENT other than HF SURGICAL EQUIPMENT that may be electrically connected to the PATIEN t circuit [SOURCE: IEC 60601 -2-2:201 7, 201 .3.207] 3.9 BIPOLAR method of applying HF current to a PATIENT between two or more ACTIVE ELECTRODES without the need for a separately connected NEUTRAL ELECTRODE (or the need to use the PATIENT ’ S body capacitance to earth) in which an effect is intended in tissue near one or more ACTIVE ELECTRODES Note 1 to entry: The BIPOLAR method includes devices energizing pairs of ACTIVE ELECTRODES as well as devices energizing groups of ACTIVE ELECTRODES where the HF current source and return may have different numbers of electrodes. [SOURCE: IEC 60601 -2-2:201 7, 201 .3.208]3.1 0 COAGULATION use of HF current to induce a thermal effect, e.g. to control or prevent bleeding, induce tissue destruction, or induce tissue shrinkage Note 1 to entry: COAGULATION may take the form of contact or non-contact COAGULATION . Note 2 to entry: FULGURATION , desiccation, spray, forced, swift, soft and argon beam (plasma) COAGULATION are all names of COAGULATION types. [SOURCE: IEC 60601 -2-2:201 7, 201 .3.21 0] 3.1 1 CONTACT QUALITY MONITOR circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to a MONITORING NE providing an alarm in the event that NEUTRAL ELECTRODE ( NE ) contact with the PATIENT becomes insufficient Note 1 to entry: A CONTACT QUALITY MONITOR is functional only when used with a MONITORING NE . [SOURCE: IEC 60601 -2-2:201 7, 201 .3.21 1 ] 3.1 2 CONTINUITY MONITOR circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an NE , providing an alarm in the event of electrical discontinuity in the NE cable or its connections [SOURCE: IEC 60601 -2-2:201 7, 201 .3.21 2] 3.1 3 CUTTING division of body tissue caused by the passage of HIGH FREQUENCY current of high current density at the ACTIVE ELECTRODE ( S ) [SOURCE: IEC 60601 -2-2:201 7, 201 .3.21 4]