IS 7583 (1991): Medical Electrical Equipment
Contents
1. 1 Supply mains 2 Table made of insulating material 3 hf surgical equipment 4 Active electrode 5 Neutral electrode metallic in contact with metal foil of the same size 6 Load resistance 200 ohms 7 Measuring resistance 200 ohms 8 hf current meter Fic 1 MEASUREMENT Or hf LEAKAGE CURRENT EARTH REFERENCED LOAD BETWEEN ELECTRODES For Jegends 1 to 8 se Fig 1 Fic 2 MEASUREMENT oF hf LEAKAGE CURRENT EARTH REFERENCED LOAD FROM ACTIVE ELECTRODE TO EARTH 7 For legends 1 to 8 see Fig 1 MgASUREMENT Or hf LEAKAGE CURRENT EQUIPMENT INSULATED AT hf 11 2 1 3 The requirements in 11 2 1 a b and c apply for both Type BF and Type CF equip ment 11 2 1 4 Requirements for hf enclosure leakage currents are under consideration 11 3 Dielectric Strength Test 11 3 1 Relevant provisions of IS 8607 Sec 3 shall apply 11 3 1 1 In addition requirements and tests for electrode cables are given in 11 11 11 4 Test for Anaesthetic Proof Equipment Compliance for anaesthetic proof high frequency surgical equipment shall be checked by the follow ing tests a Measurement of time interval between the commencement of the flow of inert gas from the electrode holder and the energization of the output see also B 1 4 b Verification that the flow of inert gas is maintained as long as the output is energi zed see also B 1 4 c A test fo2. BIS 1991 BUREAU OF INDIAN STANDARDS MANAK BHAVAN 9 BAHADUR SHAH ZAFAR MARG NEW DELHI 110002 December 1991 Price Group TE Electromedical Equipment Sectional Committee 19 FOREWORD This Indian Standard First Revision was adopted by the Bureau of Indian Standards after the draft finalized by the Electromedical Equipment Sectional Committee had been approved by the Medical and TWoaenital Planning Divi nan Cou nol 41144 Rei n ziii LVL This standard was first published in 1974 This revision has been carried out to align it with 601 2 2 1982 Medical electrical equipment Part 2 Particular requirements for the safety of high frequency surgical equipment issued by the International Electrotechnical Commission High frequency surgical equipment is used for surgical operations such as cutting and coagulation by means of high frequency current The use of frequencies above 0 3 MHz avoids the unwanted stimulation of nerves and muscles which result from the use of low frequency current Normally frequencies above 5 MHz are not used in order to minimize the problems associated with high frequency leakage currents However higher frequencies may be used in the case of bipolar techniques For the purpose of deciding whether a particular requirement of this standard is complied with the final value observed or calculated expressing the result of a test or analy s
3. body having a relatively small cross section area the use of bipolar techniques may g h be desirable to avoid unwanted coagula tion The output power selected should be as low as possible for the intended purpose Apparent low output or failure of the sur gical equipment to function correctly at normal operating settings may indicate faulty application of the neutral electrode _ poor contact in its connections C use of flammable anaesthetics and nitrous oxide N O and oxygen should be avoided if a surgical procedure is carried out in the region of thorax or the head unless these agents are sucked away or anaesthetic proof equipment is used Flam mable agents used for cleaning or disinfect ing or as solvents of adhesives should be allowed to evaporate before the application of high frequency surgery There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluid pooled in these areas should be mopped up before the equipment is used Attention should be called to the danger of ignition of endogen ous gases Some materials for example k m IS 7583 1991 cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the equipment For patients with cardiac pacemakers or pacemaker electrodes a possible hazard exists because in
4. 9 13 1 1 Compliance inspection shall be checked by 9 13 2 Where the active electrode holder incor porates two finger switches the switch nearer to the electrode shall activate the cutting mode and the switch further from electrode shall activate the coagulation mode 9 13 2 1 Compliance lm uon shall be checked by 9 13 3 Operation of a single output switch shall not result in the simultaneous energizing of more than one active electrode 9 13 3 For the purpose of this requirement bipolar electrode is considered to be one active electrode 9 13 3 2 Compliance shall be inspection and functional check checked by 9 13 4 Conn nectors for active and neutral electrode shall not be intercha angeable 12 4 1 C 1 shall I Lu 42 4 Fek JL Wil inspection 9 14 Electromagnetic Compatibility The equipment shall comply with the requirement specified in CISPR Publication 11 Limits and methods of measurement of radio interference characteristics of industrial scientific and medical ISM radio frequency equipment excluding surgical diathermy apparatus when the equipment is energized but the output switch is not activated 10 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST INCORRECT OUTPUT 10 1 Accuracy of Operating Data 10 1 1 Equipment shall incorporate means output control to enable the output power to
5. 1 1 High voltage is made with alternating vol tage of substantially sine wave form and having a frequency of 50 Hz after the humidity treatment specified i in IS 302 1979 and when the apparatus has attained its operating temperature 1 1 In order to prevent circuit making impul ses the test voltage i is increased within 10 seconds from 500 V to its final value and then maintained for one minute 1 2 During this test breakdown or flashover shall not occur no objection shall be made to Tha nf tact 44 125554545 UI USL and the points for high voltage test are stipulated in Table 1 nnnnna nh n Wik NDA eye de 4 2 2 is not possible to make interruptions in circuits without damaging the apparatus for the test the manner in which the purpose of this test can be achieved by other means shall be subject to agreement between the manufacturer and the testing authority In intermediate circuits separat ed from the mains part and within the applied the hish p 1 114512 passing the insulation between the live parts danger may occur to the operator the patient or the surroundings or if currents over 300 4A peak or voltages over 24 V can be transmitted to the applied part 2 1 The operation of a series connected over m mentantiqa Amt Aw an neuaelneard neratartinn Curren
6. be reduced to not more than 5 percent of the rated output power or 10 W whichever issmaller e 7 2 In the load resistance range 100 to 000 Q the output power shall increase with the increase of the output control setting 10 1 2 For output powers in excess of percent of tha vater n raat P d Pus ET ine rated output power actual power as a function of load resistance and output control setting shall not deviate from that shown in the diagrams specified in 7 5 2 by more than 20 percent IS 7583 1991 10 2 Protection Against Incorrect Output 10 2 1 The rated output power shall not exceed 400 W for any operating mode period of 1 second 10 2 1 1 Compliance shall be by i inspec tion of marking and output power load resistance curves 10 2 2 When the equipment is switched off and again switched on the mains supply is interrupted and re established the following requirements shall be complied with a The output power for a given setting of the output control shall not increase by more than 20 percent and b The mode of operation shall not be chang ed except to a stand by mode in which no output is produced 10 2 2 1 Compliance shall be checked by measure ment of output power averaged over a period of lsecond and the observation of the operating mode a with repeated operation of the mains switch of the equipment and b with interruption and re establishment
7. gas for example nitro dioxide at flow rate of 3 to 5 l min adequate in practice en Ot Ci 9 9 9 2 Compliance shall be checked by the test of 11 4 9 10 Rated Output The equipment set up to deliver its rated output power into a resistive load using the electrode cables is operated for 1 hour with a duty cycle as specified by the manufacturer but minimum with ArT Aneratine time nf 10 sanand CAS whata WAALS 74 5 of 30 seconds 9 11 Spillage The equipment shall be placed on a trolley approximately 600 mm in height so that the liquid spillage in normal use does not wet electri cal insulation or other components which when wetted are likely to affect adversely the ety of the equi nment 2 resti 2 T he relevant test shall carried out only on the front panel of the equipment and switch to con form to the protection of internal device during normal operation normal ope 9 12 Ingress of Liquids The electrical switching parts of foot switches for high frequency surgical equipment intended for use in operating rooms shall be of watertight construction IS 7583 1991 9 13 Human Errors 9 13 1 Where a double foot switch assembly is used to select cutting and coagulation output modes the arrangement shall be such that when viewed by the operator the cut pedal is on the left and the coagulate pedal on the right hand side
8. lead The equipment is operated so as to deliver the rated output power into a resistive load and the switch is closed and opened five times The alarm shall operate and the high frequency output shall be disabled at each open ing of the switch NOTE Care should be taken to see that under normal conditions the monitoring circuit does not introduce any interfering voltage for example at mains frequency or its harmonics at the neutral electrode which can adversely effect the operation of any patient monitoring equipment 11 11 Test for Electrode Cables Connectors and Handles 11 11 1 The insulation of electrode cables whe ther or not specified for re use shall be capable of withstanding a mains frequency voltage of 3 000 V rms and a high frequency voltage of twice the maximum open circuit high frequency voltage of the equipment 11 11 2 High frequency dielectric strength test for the active electrode handle is under consideration 10 11 11 3 Compliance shall be checked by the following tests a Main frequency Approximately 200 mm of the cable to be tested is formed into loop by joining suitably bared conductors at each end Itis lowered into water the conductivity of which has been increased by the addition a small amount of salt until a total length of 100 mm of insulated cable has been immersed The cable shall remain in water for at least 24 hours follow ing which the test voltage shall be appli
9. 5 dBA at a distance of 1m from the equipment An accessible sound level control may be provided but shall not reduce the sound level below 45 9 5 1 In order to enable the user to distinguish between the audible alarm called for in 9 4 and the signal specified above either the former shall be pulsed or two different frequencies shall be employed 9 5 2 Compliance shall be checked by functional check and measurement of the sound level 9 6 Neutral Electrode 9 6 1 Except for any output circuit intended only for connection to a bipolar electrode equipment having a rated output power in excess of 50 W shall be provided with a neutral eletrode 9 6 1 1 Compliance shall be checked by inspection 9 6 2 The neutral electrode should be so designed that it provides with a margin of safety an ade quate area of contact with the body and allows a return path for the high frequency current with such a low current density in the body tissue that adverse physiological or physical effects are avoided 9 6 3 The neutral electrode of equipment having a rated output power of not more than 50 W may be capacitively coupled to the patient 9 6 4 The neutral electrode shall be reliably con nected to the cable Any current used for monitor ing electrical continuity of the electrode cable and its connections shall pass through a section of the electrode 9 6 4 1 Compliance shall be checked by inspection and test of the electrical con
10. Marking a Indication of the source of manufacture b Type designation c Fabrication number d Supply voltage or voltage range Current in amperes f Operating frequency in MHz g Phase and h Rated output power in watts and the load resistance at which this power is available If relevant the symbol indicating the type of protection against electric shock shali also indicate that protection against the effects of defibrillator discharge 1 is incorporated uem A Raf 21 2644227 ee SS 7 2 Marking of Controls The output control shall additionally have a scale and or associated indicator showing relative units of high frequency output The figure shall not be used unless no power is delivered in this position 7 2 1 Graduation of the output power control scale in 10 major intervals is recommended 7 3 The location of all components shall be marked for easy identification or durin maintenance repair 7 4 Indicators Push Buttons and Audio Visual Device 7 4 1 Colours of Indicator Lights and Push Buttons Where indicator lights are a shall hava tha frnllawinae colours C LLW UAM VAR O tions shown against each na provide t he in diran na gt gt Wb th AM RASA a Green Power supply switched on b Yellow Output circuit energized but where cutting and coagulation output may be separately selected twol
11. _ ee b Notes on the application of high frequency surgical equipment These shall draw the attention of the user to certain precautions which are necessary in order to reduce the wo 44A AA THEA Www week WA SAWS risk of accidental burns 7 5 1 1 In particular advice shall be given on the following a The neutral electrode should be reliably b attached with its entire area to the patient s body and as close to the operating field as possible The patient should not come into contact with metal parts which earthed or which have appreciable capacitance to earth for example operating table supports etc The use of antistatic sheet ing is recommended for this purpose c Skin to skin contact for example between d the arms and the body of the patient should be avoided for example by insertion of dry gauze When high frequency surgical equipment and physiological monitoring equipment is used simultaneously the same patient any monitoring electrode not incorporating protective resistors high frequency chokes should be placed as far as possible from the surgical electrodes Needle moni toring electrodes are not recommended e The cables to the surgical electrodes should f be positioned in such a way that contact with the patient or other leads is avoided For surgical procedures on parts of the
12. ed for 5 minutes between the conductor or conductors and the water b High frequency test sample of the cable is prepared and immersed as in test at 11 11 3 a A quantity of transformer oil is then added just sufficient to produce a visible continuous film on the water sur face this technique reduces the curvature of the meniscus High frequency voltage produced by the equipment via a 1 2 set up high frequency transformer is applied between the cable conductor and a bare conductor in water while the equipment 15 operated in each output mode in turn at the maximum setting of the corresponding control for 30 seconds 11 11 3 1 During these tests no breakdown or flashover shall occur 11 11 4 The handle for the active electrode and its cable shall fulfil the relevant requirement of IS 8607 7 regarding sterilization 11 11 5 Any connector provided for attachment ofthe neutral electrode to its cable shall be so designed as to prevent conductive contact with the body of the patient in the event of inadvertent disconnection Compliance is checked by the following test Any cable to neutral electrode connector is dis connected from the electrode and using the stand ard test finger shown in IS 8607 Sec 3 it is verified that contact with conductive parts of the cable connector is not possible 11 12 Additional Annex routine tests are given in IS 7583 1991 ANNEX A Clause 11
13. entral Manak Bhavan 9 Bahadur Shah Zafar Marg 331 0131 NEW DELHI 110002 1331 13 75 Eastern 1 1 he C I T Scheme VII M V I P Road Maniktola 87 86 62 ALCUT A 700054 Northern SCO 445 446 Sector 35 C CHANDIGARH 160036 53 38 43 Southern C I T Campus IV Cross Road MADRAS 600113 235 02 16 Western 1 Manakalaya E9 MIDC Marol Andheri East 632 92 95 BOMBAY 400093 Branches AHMADABAD BANGALORE BHOPAL BHUBANESHWAR COIMBATORE FARIDABAD GHAZIABAD GUWAHATI HYDERABAD JAIPUR KANPUR LUCKNOW PATNA THIRUVANANTHAPURAM Printed at New India Printing Press Khuria India
14. he effects of the discharge of a cardiac defibrillator tested 5 times at an output of 400 J from the defibrillator Such equipment shall be permanently marked on the front panel to indicate that such protection is incorporated and this shall be confirmed in the accompanying documents 300 300 1 Trough with cotton wool plug 2 Gutter 3 Metal plate 4 Cone of inert gas 5 Handle with active electrode IS 7583 1991 200 All dimensions in millimetres Fic 4 IGNITION TEST ANAESTHETIC PROOx EQUIPMENT 1 DC voltage source 2 High frequency surgical equipment 3 Metal plate for equipment having an enclosure of material 4 Resistance Rz amp 10 ohms 5 Resistance 50 ohms 6 Resistance 100 ohms 7 Capacitance C 32 5 TEST ron DEFIBRILLATOR PROOFNESS 11 7 Spillage Compliance shall be checked by the following test A quantity of one litre of water is poured steadily on to the middle of the top surface of the equip ment over a period of 15 seconds Equipment in tended to be built into a wall or cabinet is test mounted as recommended by pouring water into the wall above the control panel After this treatment the equipment shall withstand the dielectric strength test and inspection shall show no trace of water on insulation for which creepage distances are specified in IS 8607 Sec 10 11 8 Ingress of Liquids Compliance shall be c
15. he equip ment as shown in Fig 2 The hf leakage current flowing from the neutral electrode is measured b Neutral electrode isolated from earth at high frequency The applied part is isolated from earth at both high and low frequen cies and the isolation shall be such that the hf leakage current flowing from each electrode through 200 non inductive resistor to earth does not exceed 150 mA when tested as described below The equipment is set up as described in 11 2 1 a Test 1 the output being un loaded Any metal enclosure of Class II equipment and internally powered equip ment shall be connected to earth Equip ment having an insulating enclosure shall be positioned earthed metal having an area at least equal to that of the base of applied parts at both high and low the equipment during this test see Fig 3 frequencies The hf leakage current is measured from each electrode in turn while the equipment is operated at maximum output setting in each operating mode 11 2 1 1 The hf leakage current requirements are under consideration 11 2 1 2 In the case of equipment specified for Bipolar application Any applied part permanent installation the tests shall be carried specifically designed for bipolar application out with the equipment fitted with mains supply shall be isolated from each and from other having a length of 3 m 3 2 4 1 D 8 7 6 1m
16. hecked by the following test The foot switch shall be completely immersed water to a depth of 150 mm fora period of 30 minutes While immersed it shall be connected in a circuit corresponding to its normal operation and actuated 50 times After completion of this test the switch shall be inspected There shall be no evidence of entry of water and the switch shall pass the dielectric strength test specified in 11 3 x 18 7583 1991 11 9 Protection Against the Effect of Short Circuiting of Electrodes The equipment shall be capable of withstanding without damage the effects of short circuiting or open circuiting the output when energized at maximum output setting 11 9 1 Compliance shall be checked by the follow ing test The electrode cables and electrodes are connected to the equipment and the output control set to the maximum position The output is then switched on and the active and neutral electrodes are short circuited for a period of 5 seconds and then open circuited for a period of 15 seconds The output is then switched off for a period of 1 minute The above cycle is repeated for a total of 10 times 11 9 1 1 After this test the equipment shall comply with all the requirements of this standard 11 10 Test for Monitor Circuit Compliance shall be checked by the following test circuit consisting of 1 000 ohm resistor in para with a switch is connected in series with the neutral electrode
17. ights may be incorporated and if 50 thev shall have the Ww dd ANA following colours en ES IL CLLUCU Cutting and Blue Coagulation Alternatively knobs may have the same colour code as stated above 7 4 2 Audio Visual Device Afailsafe audio visual device shall be provided to indicate fault condition in patient circuits 7 5 Accompanying Documents Each apparatus shall be provided with the ins tructions for use and a technical description giving the following details a Rated voltage b Frequency of supply c Symbol for protection class d Details of trolley see 9 11 e Degree of radio interference ANTT 42 intaeiBenBnes Kala ateomath ana ANM L 4 21113 Oi DEAL tad wm See Mists interference voltage for electromedical apparatus have been laid down in IS 6842 1972 f Rated output and corresponding load resis g Rated working frequency nominal atn Ph eee gener fr snort wave and in RHz for surgical units h Nominal output in watts maximum high frequency output given by the apparatus Manual containing operating instruments k Maintenance service manual m Parts list and n Circuit diagram 7 5 1 Instructions for use shall additionally contain a Information concerning the compatibility of high frequency cables in order to pre
18. is shall be rounded off in accordance with IS 2 1960 Rules for rounding off numerical values revised The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard IS 7583 1991 Indian Standard RATINIQAT ROTITDUARNIT 11 1 IN NICAL LN Ua 1VLIDIN A LITGH CIIRGICAT ROUTPMEANT 1 INDON ERNE LN SPECIFICATION p s j 2 1 SCOPE 3 4 Cutting 21 1 This standard specifies safety and performance requirements of high frequency surgical equip ment used in medical practice 1 2 Equipment having a rated output power not exceeding 50 WwW for example for micro coagula tion or for use dentistry or ophthalmology is exempted from certain requirements of this standard These exemptions are indicated in the relevant requirements 2 REFERENCES The following Indian Standards are necessary adjuncts to this standard rn IS No 302 1979 Title General and safety require ments for household and similar electrical appliances fifth revision Electrotechnical vocabulary FElantei nal AMIN AH LAIL TI ic i equipment used in medical practice Limits for electromagnetic interference first revision Medical electrical equip ment General req
19. lat ed parts which are subjected to mains voltage and the meta casing smaller than the clearances specified IS 302 1979 b Between metal foils on actuating part 1500 2 500 knobs handles and similar compo nents and their spindles when these spindles can become live in the case of a fault c Between metal casings and either of 1500 2 500 the metal foil wrapped round the fixed connection lead inside inlet guard NOTE The insulation between live parts in accordance with item ii is tested only insofaras doubt with regard to high voltage arises after inspection D D X XS si n C sn a a T 1 7583 1991 2 2 The insulation between the contacts of microswitches thermostats thermal cut outs relays etc and the insulation of capacitors are not tested A 3 In the case of Class II apparatus which has been reinforced and double insulated care should be taken that the voltage applied to the reinforced insulation does not overstress the functional or supplementary insulation When testing insulating coating the metal foil may be pressed against the insulating material by means of a sand bag of such a size that the pressure is approximately 0 005 N mm A 3 1 Care should be taken to ensure that the metal foil i
20. not exceeding 12 V if a conductive connection to the applied part exists and 24 V ac or 34 V dc in other cases 9 2 2 Under single fault condition this circuit shall not cause low frequency patient leakage current s exceeding the allowable limits 9 2 3 Compliance shall be checked by inspection functional check and measurement of voltage and leakage current s 9 3 Cord Connected Foot Switches The force required to actuate the foot switch shall be between 10 and 15 N 9 4 Monitoring Circuit Equipment having a rated output power of more than 50 W and an applied part not isolated from earth at high frequencies to the degree required in this standard shall be provided with a circuit arranged so as to de energize the output and to give an audible alarm when an interruption of the neutral electrode cable or its connections occurs audible alarm shall meet the sound level requirements of 9 5 2 and shall not be exter nally adjustable NOTE An additional visible warning should be provided consisting of a red indicator light 9 5 Output Indicator A device shall be incorporated which gives an audible signal when any output circuit is energi zed by the operation of an output switch or as a result ofa single fault condition The sound output shall have its major energy content in the band of frequencies between 100 and 1000 Hz The sound source shall be capable of producing a sound level of at least 6
21. of the mains supply the switch in the equip ment being left in the position 11 TESTS 11 1 High Voltage and Resistance Test Routine Tests 1 1 1 High Voltage Test 11 1 1 1 High voltage test shall be carried out in accordance with Annex test voltage be tween output circuit and any other terminal of the unit having U as their working voltage shall be 20 4 500 11 1 1 2 The surgical apparatus is operated with 110 percent of the rated supply voltage for 30 minutes and after this operation the high fre quency insulators shall be checked for no change and satisfactory operation 11 1 2 Insulation Resistance Test The insulation resistance test is with direct voltage of approximately 500V immediately after the humidity treatment specified in 4 10 of 1S 8607 Sec1 the measurement being made one minute after the application of the voltage and heating elements if any being disconnected The insulation resistance is measured The measured value between live parts and the casing shall not be less than those stated below functional insulation 5 and reinforced insulation 7 N OTE The term casing as used above includes all accessible metal parts shafts of carrying handles and knobs and similar components and a metal foil not larger than 200 mm x I00 mm which lies on the sur face of the external parts of insulating mate
22. oo h Oo Oo OO OO Oo oe k k Disclosure to Promote the Right To Information Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities in order to promote transparency and accountability in the working of every public authority and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public particularly disadvantaged communities and those engaged in the pursuit of education and knowledge the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public bl 19 BT Bl TT qum Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru The Right to Information The Right to Live Step Out From the Old to the New 593 1991 Medical Electrical Equipment High Meeeuency Surgical Equipment MHD 19 Immuno Biological EM Unostic Kits Satyanarayan Gangaram Pitroda Bhartrhari Nitisatakam oo OO kkk oo kkk BLANK PAGE PROTECTED BY COPYRIGHT IS 7583 1991 NES d WT Reaffirmed 2001 fafacdia faga www afa fafaa stent TAT qadam Indian S tandard MEDICAL ELECTRICAL EQUIPMENT HIGH FREQUENCY SURGICAL EQUIPMENT SPECIFICATION First Revision UDC 615 846
23. r ignition is performed with the device shown in Fig 4 The cotton wool plug in the trough 1 is wetted with a few millilitres of ether ether vapour flows via the gutter 2 on to the metal plate 3 The handle 5 with the electrode approximates the metal plate at a distance of about 150 mm from the end of the gutter Sparking at the electrode shall not produce ignition of the ether mixture or air mixture The shall performed with the equipment set to maximum output Where selection cut or coagulate modes is provided the equipment shall be tested in each of these modes The test shall be performed with all electrodes supplied for use with the equipment 11 5 Output Test 11 5 1 Requirements of 10 1 shall be verified by the following test Measurement of output power as a function of output control setting at four values of toad resistance in the range 100 to 1000 ohms for example at100 200 500 and 1 000 ohms The electrode cables shall be used for connection of the load resistors The high frequency current I is measured through the known resistance R and the output W is obtained by the formula Wzzl R 11 5 2 Compliance of 10 1 2 shall be checked by performing the test of 11 5 1 but using appropriate values of load resistance 11 6 Protection Against the Effects of Defibrillator Discharge Equipment having a rated output power of more than 50W shall be provided with protection against t
24. rial The metal foil shall have the largest area possible that can be placed for the test on the surface of the apparatus to be tested but shall not be larger than the dimensions stated above 11 2 Test for High Frequency Leakage Current 11 2 1 The applied part shall depending on its design comply with the relevant section of the following requirements a Neutral electrode reference to earth The applied part is isolated from earth but the neutral electrode is referenced to earth at high frequencies by component for exam ple a capacitor satisfying the require ments of Type BF equipment When tested as described below the hf leakage current flowing from the neutral electrode through a non inductive 200 Q resistor to earth shall not exceed 150 mA Compliance shall be checked by the follow ing tests Test 1 The test is performed on the equipment with the electrode cables and electrodes as shown in Fig 1 The cables A are spaced 0 5m apart on an insulating surface 1 m above the floor or any conduct ing plane The output is loaded with 200 Q and the equipment is operated at maximum output setting in each operating mode The hf leakage current flowing from the neutral electrode through a non induc tive resistor of 200 to earth is measured Test 2 The equipment is set up as for Test 1 but the 200 Q load resistor is con nected between the active electrode and the protective earth terminal of t
25. rns Small area contacts with objects having a low impedance to earth at high frequencies may result in high current densities and hence unwanted burns c There may be some high frequency voltage d difference between these parts of the patient s body which may cause an unwanted current to flow The current flowing to the leads of the monitoring equipment may cause burns at the site of the electrodes AS 7583 1991 e The capacitance between the electrode cable and the patient may result in some local high current densities f Specially where bony structures and having a relatively high resistance are involved bipolar techniques can avoid unwanted tissue damage g Output power shall be minimum required h Techical description output data diagram shall be provided These diagrams should enable the user to judge the suit ability of equipment a particular purpose and j It should be made clear to the user whether the applied part is completely floating or referenced to earth at high frequency 9 CONSTRUCTION 9 1 Provisions of IS 8607 Sec 10 shall apply except as stated below 9 2 Switches In addition to the mains switches an output switch finger or foot switch shall be provided requiring continuous activation to energize the output circuit 9 2 1 The switching circuit shall be supplied from a power source isolated from the mains part and from earth and having a voltage
26. s positioned in such a manner that flashover does not occur at the edges of the insulation A 4 High voltage test may be limited to places where the insulation is likely to be weak for example where there are sharp metal edges under the insulation 4 1 If possible insulating linkings shall be tested separately ANNEX B Clauses 11 4 and 11 12 TESTING DURING MANUFACTURE AND OR INSTALLATION 1 ADDITIONAL ROUTINE TESTS B 1 1 Measurement of dc resistance between the active and neutral electrode terminals or between the two terminals for a bipolar electrode respec vely see 9 7 B 1 2 Functional test of any monitoring circuit B 1 3 Measurement of rated output power B 1 4 For anaesthetic proof equipment the follow ing test is required to be carried out B 1 4 1 The test is performed with the device shown in Fig 6 Instead of the inert gas normally used compressed air isfed with a flow of 3 to 5 litres per minute through the handle The supply pipe is connected bottle having a capacity of approximately one litre which contains 700 ml of an aqueous solution of ammonia The handle 12 active electrodes supplied for use with equipment the hf output control may be set to with electrode is directed towards the plate which is covered with a suitable indicator paper for example universal pH indicator paper range 1 10 which has been moistened with water air ammonia mixture will prod
27. t protective UL 1475444 LUULLA device in the apparatus may constitute a danger within the meaning of this specification tect onlu made if by by di iab d M M VERA 44 NE mart Table 1 Test Voltage Clause 1 2 S1 No Voltage Test Voltage V _ Protection Protection Class Class II ft AX i 19 1 Between all parts having a conducting 1U 1000 2U 3000 connection with the mains mains part 2 000 Min 4 000 Min on the one hand and the applied part and the casing on the other hand ii Between parts within the mains part input asf dese Ner Whe wre ve SG AR ES4 54469414 X eee part or within the applied part output part between which occurs a voltage U U up to 24 V 500 500 b U over 24 V 20 1000 2U 1000 1 500 Min 1 500 Min iii Between parts of Class II apparatus a Between the mains part and non 1 500 accessible metal parts functiona insulation of the Class II apparatus b Between non accesible metal parts and 2 500 casing supplementary insulation of a Class II apparatus x 15 ninss anda land antrias Ansuia 41145 4108 55 575713 ICU dcp Between metal casings having 1 500 2 500 insulating lining and metal foil on the inner surface of the lining when the clearance between functionally insu
28. ted burns are avoided NOTE The neutral electrode is also known as plate electrode passive or dispersive electrode 3 8 High Frequency hf Surgical Equipment Medical electrical including associat ed accessories intended for the performance of surgical operations such as cutting or coagulation of biological tissues by means of high mequency f Lf X Bum 4 hf CULICIIL 3 3 Rated Output Power Maximum high frequency power which can be fed into a non reactive load resistor having a resistance between 50 and 2000 ohms in case of monopolar output circuit and between 10 and 1000 ohms in case of bipolar circuit 4 GENERAL REQUIREMENTS Relevant provisions of IS amp 607 Sec 1 to 10 shall apply 5 GENERAL REQUIREMENTS FOR TESTS B1 D OLN Wok Provisions of LO OVU Sec i t apply except additional routine tests se 4 rcicrence is 111 to electrode cables IS 7583 1991 supplied or recommended by the manufacturer shall be used 5 3 Sequence The test called for protection against the effects af diacharvae chall he nerfarmed aiscuargco Shaun DCrioillntu to the leakage current and dielectric strength tests 6 GLASSIFICATION The equipment shall be of Class I or II and Type BF or GF 7 IDENTIFICATION MARKING AND DOCUMENTS 4 1 7 1
29. terference with the action of the pacemaker may occur or the maker may be damaged In case of doubt reference should be made to the cardiology department for advice The possibility of interference to other medical electrical equipment due to the operation of high frequency surgical equipment 4 9 2 The technical description shall contain the following output data a Diagrams showing the power output at full b c Designation and half setting of the output control over the range of load resistance 50 to 2 000 ohms for the following operating modes if available 1 Cutting 2 Coagulation and 3 Blend any variable Blend control being set to the maximum position Diagrams showing the power output versus the output control setting at a specified load resistance in the range 50 to 2 000 ohms for the operating modes listed above and of the applied part s see 11 2 8 SAFETY REQUIREMENTS 8 1 The equipment shall satisfy the relevant safety requirements of IS 8607 Sec 1 8 2 To avoid safety hazards the following considerations should be taken into account a Minimizing the distance between the ope b rating field and the neutral electrode reduces the load resistance and for a given power at the site of the active electrode the power output required from the equip ment and also the high frequency voltage across the patient so as to reduce the hazard of unwanted bu
30. tinuity 9 7 Neuromuscular Stimulation To minimize the possibility of neuromuscular stimulation the dc resistance between active and neutral electrode terminals or between the ter minals of a bipolar output circuit shall be not less than 2 9 7 1 The effective series capacitance should not exceed 5 000 pF 9 7 2 Compliance shall be checked by inspection of de resistance between the output terminals 9 8 Cooling Fans 9 8 1 Cooling fans if incorporated arranged that in normal use directed away from the patient shall De s any draugt ht is n el AU PRENDS orm fara ah a ala ha NIIT VC ICE USG Ui CUUIIIE VU avoided 9 8 3 Compliance shall be checked by inspection of the and the accompanying docu 1e nt P 9 9 Anaesthetic Proof High Frequency Surgical Equipment 9 9 1 At least the applied part of equipment specified for use with flammable anaesthetics shall be anaesthetic proof and marked and shall comply additionally with the following require ments 9 9 1 1 Cutting or coagulation electrodes shall be provided with a holder equipped with a means for directing a stream of inert gas towards the operating site arrangement shall be such as to ensure that the inert gas flow is started at least second before the output is energized and the gas flow is stopped only after the output is de energized NOTE Inert
31. uce a change in the colour of the indicator paper corresponding to the area of the gas flow surrounding the active electrode The test should be repeated with all the minimum power throughout the test In each case the entire electrode shall be within the stream of gas as shown by the indicator paper The test may be used to check compliance with the requirement that the inert gas flow is started before the output power is switched on and that the gas flow stops after the output power is switched off _ 1 7583 1991 INDICATOR qme lt GAS MIXTURE AIR FLOW HANDLE WITH ACTIVE ELECTRODE il ani Fic 6 ADDITIONAL ROUTINE TEST FOR ANAESTHETIC PROOF EQUIPMENT 13 Standard Mark The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act 1986 and the Rules and Regulations made thereunder The Standard Mark on products covered by an Indian Standard conveys the assurance that they have been produced to comply with the requirements of that standard under a well defined system of inspection tosting and quality control which is devised and supervised by BIS and operated by the producer Standard marked products are also continuously checked by BIS for con formity to that standard as a further safeguard Details of conditions under which a licence for the use oft he Standard Mark may be granted to man
32. ufacturers or producers may be obtained from the Bureau of Indian Standards Bureau of Indian Standards BIS is a statutory institution established under the Bureau of Indian Standards Act 1986 to promote harmonious development of the activities of standardization marking and quality certification of goods and attending to connected matters in the country Copyright BIS has the copyright of all its publications No part of these publications may be reproduced in any form without the prior permission in writing of BIS This does not preclude the free use in the course of implementing the standard of necessary details such as symbols and sizes type or grade designations Enquiries relating to copyright be addressed to the Director Publications BIS Revision of Indian Standards Indian Standards are reviewed periodically and revised when necessary and amendments if any are issued from time to time Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition Comments on this Indian Standard may be sent to BIS giving the following reference Doc 19 2220 Amendments Issued Since Publication Amend No Date of Issue Text Affected BUREAU OF INDIAN STANDARDS Headquarters Manak Bhavan 9 Bahadur Shah Zafar Marg New Delhi 110002 Telegrams Manaksanstha Telephones 331 01 31 331 13 75 Common to all Offices Regional Offices 1 Telephone C
33. uire ok Jtt dE revision under preparation 8607 Sec 1 to 10 eat w f menis NOTE Till such time the standard under prepara tion is published the matter shall be as agreed to between the concerned parties 3 TERMINOLOGY DL 3 1 following definit i given in IS 1885 Part 43 3 2 pplied Part A PPP EON aaaition thos l 1977 shall apply 15 Output circuit including active neutral and bipolar electrodes 3 3 Coagulat tion Sealing of small blood Vessels or body tissues ranga he the nt AGRA 5 Hy t ie passage high ii vQuuvciicy current at the active electrode see 3 5 Section of body tissue caused by the passage of high frequency current of high current density at the point of the active electrode see 3 5 3 5 Electrode Active Electrode intended to produce certain physical effects required in electrosurgery for example cutting and coagulation 3 6 Electrode Bipolar Assembly of two active electrodes on the same support and so energized that the current flow mainly between these two eletrodes 3 7 Electrode Neutral Electrode of relatively large area for connection to the body of the patient to provide a return path for the high frequency current with such a low current density i in the body tissue that physical effects such as unwan
Download Pdf Manuals
Related Search