IEC TR 61289:2011 pdfダウンロード

IEC TR 61289:2011 pdfダウンロード。High frequency surgical equipment – Operation and maintenance
Scope
This technical report contains guidelines for medical and nursing personnel regarding the safeand effective operation of HIGH FREQUENCY SURGICAL EQUIPMENT (also referred to as HSURGICAL EQUIPMENT in this document). It will also be of use to scientific/technical staff whohave responsibility for the maintenance of this equipment.
The application guidelines in this document deal with the safe operation of HIGH FREQUENCYSURGICAL EQUIPMENT constructed according to the safety requirements of IEC 60601-1 andIEC 60601-2-2(see Biblography)
Not all existing HIGH FREQUENCY SURGICAL EQUIPMENT meets the minimum requirements ofcurrent international standards, however, the guidelines in this report will still be helpful inutilizing these devices.
This report assumes that the electrical installation of HIGH FREQUENCY SURGICAL EQUIPMENTmeets national and local regulations for medically used rooms.
2 Terms and definitions
For the purpose of this document, the following terms and definitions apply
2.1
ACCESSORYadditional part for use with equipment in order to:
achieve the intended use.
adapt it to some special use
facilitate its use,
enhance its performance,orenable its functions to be integrated with those of other equipment[SOURCE:IEC 60601-1:2005,definition 3.3]
2.2
ACTIVE ACCESSORY
HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to produce surgicaleffects at the intended site on the patient, generally comprising an ACTIVE HANDLE, cord of anACTIVE ACCESSORY.ACTIVE CONNECTOR and ACTIVE ELECTRODE
[SOURCE:IEC 60601-2-2:2009,definition 201.3.201]
2.3ACTIVE CONNECTOR
part of an ACTIVE ACCESSORY intended for connection to an ACTIVE OUTPUT TERMINAL. whichmay include additional terminals for connection of a FINGERSWITCH to a SWITCH SENSOR
[SOURCE:IEC 60601-2-2:2009,definition 201.3.202]
2.4
ACTIVE ELECTRODE
part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site
[SOURCE:IEC 60601-2-2:2009,definition 201.3.203]
2.5
ACTIVE HANDLE
part of an ACTIVE ACCESSORY intended to be held by the OPERATOR[SOURCE:IEC 60601-2-2:2009,definition 201.3.205]2.6
ACTIVE OUTPUT TERMINAL
part of HF SURGICAL EQUIPMENT Or ASSOCIATED EQUIPMENT intended for connection to an ACTIVEACCESSORY and for delivery of HF current thereto
[SOURCE:IEC60601-2-2:2009,definition 201.3.206
2.7
APPLIED PART
part of ME EQUIPMENT that in normal use necessarily comes into physical contact with thepatient for ME EQUIPMENT or an ME SYSTEM to perform its function
[SOURCE:IEC 60601-1:2005,definition 3.8]
2.8
ASSOCIATED EQUIPMENTequipment other than HF SURGICAL EQUIPMENT that may be electrically connected to thePATIENT circuit and not intended for independent use
[SOURCE:IEC60601-2-2:2009definition 201.3.207]
2.9BIPOLARmethod of applying HF output current to a patient via multiple-pole ACTIVE ELECTRODES[SOURCE:IEC 60601-2-2:2009,definition 201.3.208]
2.10
COAGULATIONuse of HF current to elevate the temperature of tissue, e.g. to reduce or terminate undesiredbleeding
Note to entry: COAGULATION may take the form of contact or non-contact COAGULATION.ISOURCE:IEC60601-2-2:2009.definition 201.3.2101
2.11
CONTACT QUALITY MONITOR
circuit in HF SURGICAL EQUIPMENT Or ASSOCIATED EQUIPMENT intended for connection to aMONITORING NE providing an alarm in the event that NEUTRAL ELECTRODE (NE) contact with thepatient becomes insufficient