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1、7 II J I S T*1453 86 4933608 0073295 b 1 i UDC 61 5.472:621.3:616-O89 JAPANESE INDUSTRIAL STANDARD Electrosurgical Units Translated and Published by Japanese Standard$ Association Printed in Japan 1 0 s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Emplo
2、yees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- In the event of any doubt arising, the original Standard in Japanese is to be final authority. Copyright Japanese Standards Association Provided by IHS und
3、er license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*1Y53 86 = 4933b08 0071297 T 1 . T 1453-1986 Contents Page 1 . Scope i 2; Definitions 3 . Service Conditions 4
4、. Safety 4.1 Electrical Safety . 4.2 Mechanical Safety . 4.3 Protection against Excessive Temperature. Fire and Other Hazards . 5 . Classification 6 . Performances 6.1 Main Carrier Frequency . 6.2 Deviation of Output Control 6.3 Maximum Output Power . 6.4 6.5 Increase of Output Power and Minimum Out
5、put Power Sound Indicating Output Power . ; . 6.6 6.7 Dielectric Strength of Electrode Cord . High Frequency Leakage Current . 7. Configuration and Construction . 7.1 Configuration . 7.2 Construction 8 . Tests 8.1 Test Conditions . 8.2 Test Items . 8.3 Continuity and Dielectric Strength of Electrode
6、 Cord 8.4 Leakage Current . 8.5 High Frequency Leakage Current 8.6 Protection against Neuromuscular Stimulation 8.7 Monitoring Circuit of Neutral Electrode . 1 1 2 2 2 4 4 4 4 4 4 4 4 4 5 5 5 5 5 7 7 7 7 8 8 10 10 1 Copyright Japanese Standards Association Provided by IHS under license with JSALicen
7、see=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- I J I S T*LY53 Bb R 4933608 007L298 L T 1453-1986 Page 8.8 Protection against Effects of Defibrillator 10 8.9 Protection against Short-circuit
8、 of Electrodes . 10 8.1 O Excessive Temperature . 11 8.11 Output Power 11 8.12 Sound Indicating Output Power 11 8.13 Output Switch and Foot Switch . 11 8.14 Connector for Neutral Electrode Cord 11 9 . Marking 12 10 . Attached Documents 12 2 Copyright Japanese Standards Association Provided by IHS un
9、der license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- I1 UDC 6 15.472:621.3:6 16-089 JAPANESE INDUSTRIAL STANDARD J I S Electrosurgical Units T 1453-1986 1 Scope This Japa
10、nese Industrial Standard specifies electrosurgical units and accessories used in medical operations such as cutting, coagulation or mixing of body tissue. This unit is generally called as electrical knife and generates the maximum power of 50 W and more at main carrier frequency of 0.3 to 5 MHz. 2.
11、Definitions I- For the main terms used in this Standard the definitions in JIS T 1001 apply, and the rest of the terms shall be as follows: I i active electrode It is used being supported by the holder. Electrode intended for cutting, coagulation or mixing. neutral electrode body of the patient to a
12、void unwanted burns. known as a dispersive electrode. Electrode of relatively large area for connection to the The neutral electrode is also bipolar electrode support and so energized that main HF current flows through the body tissue between these two electrodes. Assembly of two insulated electrode
13、s on the same applied part (Including the plugs and cords for them.). Active electrode, neutral electrode and bipolar electrode cutting cutting of body tissue. One of the functions of the active electrode, i.e. incision or coagulation electrode, i.e. coagulation or hemostasis of body tissue. One of
14、the functions of the active electrode or the bipolar mixing operating mode bipolar. Mixing of cutting function and coagulation function. Output power mode of cutting, coagulation, mixing and main carrier frequency generated by an electrosurgical unit. Main components of high frequency current main h
15、igh-f requency currents through the applied part. Normal high-f requency currents flowing high-f requency leakage currents of normal high-f requency current path. High-f requency currents which flows out Applicable Standards, Corresponding International Standard and Reference Standards: See page 14.
16、 Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*1453 86 H 49336138 81371i308 b 2 T 1453-1986 grou
17、nded type (non-floating type) A type of electrosurgical units in which the neutral electrode circuit is insulated from the ground for the frequency of power supply, but grounded for the main carrier-frequency. non-grounded type (floating type) high-frequency output circuit is insulated from the grou
18、nd for the main carrier frequency. A type of electrosurgical units in which rated output power Maximum high frequency output power which can be fed into a non-reactive load resistor having a optional resistance between 50 to 2000Q specified by the manufacturer. single fault condition of electrosurgi
19、cal unit in 2. (53) of JIS T 1001. including. the breaking. or disconnection of a cord The fault condition given of the neutral electrode of electrkn-gical unity and a defect in the output switching circuit or the dielectric breakdown in the output circuit resulting in an excessive low frequency pat
20、ient leakage current. output switch Hand or foot switch used for operating output circuits. 3. Service Conditions The conditions shall be as specified in 3. of JIS T 1001. 4. Safety 4.1 Electrical Safety The electrical safety shall comply with the following requirements in addition to compliance wit
21、h 6. of JIS T 1001. (1) The type and level of protection against electrical shock shall be as given below based on the classification specified in JIS T 1001. (a) Classification by the type of protection against electrical shock: I or Class II equipments Class (b) Classification by the level of prot
22、ection against electrical shock: BF or Type CF Type Operation Mode the set output power and operation mode do not change when it is switched on and off or main supply is interrupted and re-established. The electrosurgical unit shall be so constructed that Output Terminal the active electrode plug ca
23、nnot be erroneously connected with the active electrode terminal, neutral electrode terminal or bipolar electrode terminal of its main body. The electrosurgical unit shall be constructed so that Protection against Neuromuscular Stimulation possibility of neuromuscular stimulation, the d.c. resistanc
24、e between active electrode terminal and neutral electrode terminal or between the bipolar electrode terminals shall be not less than 2 MQ. The equivalent capacitance (e.g. combined capacitance of C, C, C, sown in Fig. 1) shall not exceed 5000 pF. To minimize the Copyright Japanese Standards Associat
25、ion Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S TE1453 Bb m 4733608 c1071301 B m 3 I T 1453-1986 Fig. 1. An Example of Output Circuit of
26、Grounded Type Equipment 0 Active electrode Neutral electrode 1 I Monitoring Circuit I- (5) Monitoring Circuit for Neutral Electrode disconnection in the neutral electrode circuit occurs, the equipment shall When an interruption or a stop the output power automatically and the monitoring circuit shal
27、l exert alarm by audible sound and visible light. The alarm by audible sound shall be not less than 65 dB when measured by the sound level meter with A weighting specified in JIS C 1502, at a distance of 1 m from the equipment. controlled from outside. This alarm shall not be The visible light alarm
28、 shall employ red display lamp. The monitoring equipment shall be operated with the insulated power supply with the maximum voltage not exceeding 12 Vdc or 12 Vac . shall be equipped with protection against the effects of the discharge of a cardiac defibrillator. Such equipment shall bear the symbol
29、 (Fig. 2) which indicate that the defibrillator is incorporated, on the control panel or a position easily visible by operator, and this note shall be stated in the attached documents. (6) Protection against Effects of Defibrillator The electrosurgical unit Fig. 2. Symbols Indicating Protection Agai
30、nst the Effects of Defbrillator Discharge With protection With protection against defbrillator against defbrillator Type BF Type CF . (7) Protection of Output Circuit against Short-circuit The equipment shall not be damaged, when the output circuit is short-circuited or open-circuit&, while the outp
31、t control is set at the maximum output and the output switch is closed. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license f
32、rom IHS -,-,- J I S T*3453 8b 4933608 0073302 T 4 T 1453-1986 4.2 Mechanical Safety The mechanical safety shall be as specified in 7 of JIS T 1001. 4.3 Protection against Excessive Temperature, Fire and Other Hazards The protection against excessive temperature, fire and other hazards shall be as sp
33、ecified in JIS T 1001 and the addition requirements are as follows. (1) Excessive Temperature The equipment shall meet the specifications of 8.1 in JIS T 1001 when it is tested according to 8.10. (2) Water-resistance It is recommended that the enclosure of the electrosurgical unit is drip-proof cons
34、truction. 5. Classification Electrosurgical units are classified into, grounded type (non-floating type) and non-grounded type (floating type). 6. Performances 6.1 Main Carrier Frequency Main carrier frequency of the electrosurgical unit shall be 0.3 to 5 MHz. 6.2 Deviation of Output Control The dev
35、iation of the output control shall be as follows: (1) When the rated power supply voltage fluctuates in the range of & 10 %, the output shall meet with the setting within t : 20 % of the cariblation table shown in the technical documents provided by manufacturer, in the range of output power not les
36、s than 10 % of the rated output power. (2) When the output switch is opened and closed again or main supply is interrupted and reestablished, the deviation of output power shall not exceed the range of i 20 %. 6.3 Maximum Output Power The output power of electrosurgical unit shall not exceed 400 W a
37、s averaged over any period of one second under the noninductive load resistance in the range 50 to 2000 i2 specified by manufactures, in any operating mode. 6.4 Increase of Output Power and Minimum Output Power The output power of electrosurgical unit shall increase with an increase of output contro
38、l setting under the noninductive load resistance specified by manufacturer. The output power at the minimum position shall not exceed 5 % of the rated output power and shall be 10 W or less. 6.5 Sound Indicating Output Power When the output circuit is in operation, an audible sound at a frequency 10
39、0 to 1000 Hz which can be discriminated from the audible alarm sound specified in 4.1 (5) by the operator shall be exerted. The sound level shall be 65 dB or more, when measured by the sound level meter with A weighing specified in JIS C 1502 at a distance of one meter from the equipment. Copyright
40、Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*3453 8b m 4933608 0073303 L m L 5 T 1453-1986 The sound leve
41、l is allowed to be regulated, but the equipment shall be so constructed that the sound level does not fall below 45 d3. .6.6 Dielectric Strength of Electrode Cord The cords of an active electrode, an neutral electrode and a bipolar electrode of the electrosurgical unit shall be capable of withstandi
42、ng 3000 Vac (r.m.s. power frequency) for a period .of 5 min and a high frequency voltage of twice the maximum open-circuit high frequency voltage (r.m.s.) of the equipment for a period of 30 s. 6.7 High Frequency Leakage Current the electrosurgical unit shall not exceed 150 mA. The high frequency le
43、akage current of 7. Configuration and Construction 7.1 Configuration An electrosurgical unit consists of main body (power supply unit, power supply switch, high frequency generating circuit, output controller, output switch, display lamp) and its associated accessories (electrode unit, foot switch,
44、power supply cords). 7.2 Construction e 7.2.1 Output Power Controller capable of being read on the scale or display of output power controller by the aid of the calibration table or the like. display, high frequency output power shall not be delivered at this position. The high frequency output powe
45、r shall be When the figure “O“ is used in the scale or 7.2.2 Output Switch In addition to the main switch an output switch (hand or foot switch) which can be operated continuously shall be provided to energize the output circuit. The switch shall comply with the following requirements: (1) The switc
46、hing circuit shall be fed from a power source insulated from the main part and from the ground, having a voltage not exceeding. (a) 12 V for hand switch b) 24 Vac or 34 Vdc for foot switch Operation of a single output switch shall not result in the simultaneous energizing of more than one active ele
47、ctrode. The electrical switching part of foot switch shall have drip-proof construction. The force required to actuate the foot switch shall be in a range of 10 to 50 N. When a dual foot switch is used to select the output for cutting or coagulation the switching device shall be so constructed that
48、the cutting pedal is in the left and the coagulation pedal is in the right viewed from the operator side. When two hand switches are assembled in an active electrode holder, the switch nearer to the electrode shall activate the cutting mode anc, the switch further from -the electrode shall activate the coagulation mode. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 09:02:22 MDTNo reproduction or network