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Introduo
Nos E.U.A., cerca de 10.000 acidentes por ano causados por equipamentos mdicos (dados de 1998) Quality Review in Anesthesia, Vol. 10, Issue 1, March/April 2007
Introduo
Projeto com SEGURANA:
tudo que PODE dar errado considerar que VAI dar errado.
Fontes de risco: fogo, ar, gua, drogas, microorganismos, infeco, lixo, som, eletricidade, raio X, materiais cortantes, etc.
Figure 14.1 Physiological effects of electricity Threshold or estimated mean values are given for each effect in a 70 kg human for a 1 to 3 s exposure to 60 Hz current applied via copper wires grasped by the hands.
Figure 14.2 Distrubutions of perception thresholds and let-go currents These data depend on surface area of contact (moistened hand grasping AWG No. 8 copper wire). (from C. F. Dalziel, "Electric Shock," Advances in Biomedical Engineering, edited by J. H. U. Brown and J. F. Dickson IIII, 1973, 3, 223-248.)
Figure 14.3 Let-go current versus frequency Percentile values indicate variability of let-go current among individuals. Let-go currents for women are about two-thirds the values for men. (Reproduced, with permission, from C. F. Dalziel, "Electric Shock," Advances in Biomedical Engineering, edited by J. H. U. Brown and J. F. Dickson IIII, 1973, 3, 223-248.)
Figure 14.4 Fibrillation current versus shock duration. Thresholds for ventricular fibrillation in animals for 60 Hz ac current. Duration of current (0.2 to 5 s) and weight of animal body were varied. (From L. A. Geddes, IEEE Trans. Biomed. Eng., 1973, 20, 465-468. Copyright 1973 by the Institute of Electrical and Electronics Engineers. Reproduced with permission.)
Figure 14.6 Simplified electric-power distribution for 115 V circuits. Power frequency is 60 Hz.
Figure 14.7 Power-isolation-transformer system with a line-isolation monitor to detect ground faults.
231 g/kW.h
RADITOR ELECTRIC STARTING 220 V/ 380 V 115 A 50 HZ 0.8
PHASE CONNECTION
PACKING SIZE L*W*H (mm)
3-PHASE 4-WIRE
2500 * 950 * 1300
Sistema No-Break
20A para cachorro 80 a 600 A para humanos 10A limite aceito como seguro
MACROCHOQUE
Resistncia da pele: seca e intacta de 15 kW a 1 MW.
Valor cai 100 vezes quando a pele est molhada ou apresenta algum corte! Resistncia interna 200W por membro e 100W no tronco (= 500W entre braos!)
Falha em equipamentos
Chassis ou gabinete no aterrado Falha de isolao Componente em curto Estresse mecnico em cabos Fluidos (sangue, urina, solues...) espirrados acidentalmente
No pode existir corrente pelo fio terra. Sempre verificar sua condutividade!
Figure 14.8 Macroshock due to a ground fault from hot line to equipment cases for (a) ungrounded cases and (b) grounded chassis.
MICROCHOQUE
Corrente de fuga: Capacitncias parasitas de cabos prximos, ou Resistncia de sujeiras, umidade ou m isolao. Falta de aterramento ou alta resistncia no terra. I max = 10 A (normas de 10 a 100 A)
Figure 14.9 Leakagecurrent pathways Assume 100 A of leakage current from the power line to the instrument chassis. (a) Intact ground, and 99.8 A flows through the ground. (b) Broken ground, and 100 A flows through the heart. (c) Broken ground, and 100 A flows through the heart in the opposite direction.
Figure 14.11 (a) Large ground-fault current raises the potential of one ground connection to the patient. The microshock current can then flow out through a catheter connected to a different ground.
NORMAS
IEC - International Electrotechnical Commission Norma IEC 60.601-1 Norma geral de segurana eltrica. Normas IEC 60.601-2-X Especficas para cada tipo de equipamento mdico.
IEC 60601-2-X MEDICAL EQUIPMENT - PART 2: REQUIREMENTS FOR THE SAFETY OF...
IEC 60601-2-2 HIGH FREQUENCY SURGICAL EQUIPMENT IEC 60601-2-4 CARDIAC DEFIBRILLATORS AND DEFIBRILLATORS - MONITORS IEC 60601-2-5 ULTRASONIC PHYSIOTHERAPY EQUIPMENT IEC 60601-2-10 NERVE AND MUSCLE STIMULATORS IEC 60601-2-12 LUNG VENTILATORS FOR MEDICAL USE IEC 60601-2-16 HAEMODIALYSIS EQUIPMENT IEC 60601-2-19 BABY INCUBATORS IEC 60601-2-22 DIAGNOSTIC AND THERAPEUTIC LASER EQUIPMENT IEC 60601-2-24 INFUSION PUMPS AND CONTROLLERS IEC 60601-2-25 ELECTROCARDIOGRAPHS IEC 60601-2-26 ELECTROENCEPHALOGRAPHS IEC 60601-2-27 ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT IEC 60601-2-30 NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT IEC 60601-2-33 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS IEC 60601-2-37 ULTRASONIC MEDICAL DIAGNOSIC AND MONITORING EQUIPMENT IEC 60601-2-38 ELECTRICALLY OPERATED HOSPITAL BEDS IEC 60601-2-40 ELETROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT IEC 60601-2-51 RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
Isolation barrier
CM
1 a 10 kV e R > 10MW
RF
Error ~
ISO
CMRR
SIG
IMRR* ~
Error +
~
Isolation barrier
ISO
CM
~ ~
Input common
(a) *IMRR in v/v
ISO
Output common
o =
SIG
CM
ISO
Figure 14.14 Electrical isolation of patient leads to biopotential amplifiers (a) General model for an isolation amplifier.
FB
In In +
SIG
Mod
+ 5V F.S.
Demod 5V F.S.
Hi o
Lo
In com +ISO Out -ISO Out Power Rect and filter 25 kHz
+ 7.5 V
- 7.5 V
Oscillator 25 kHz
+ 15 V DC
Power return
(b)
Figure 14.14 Electrical isolation of patient leads to biopotential amplifiers (b) Transformer isolation amplifier (Courtesy of Analog Devices, Inc., AD202).
1
+o AI +
RG
i1 ~
i2 i3
o
-
Input control
o = i
RK RG
(c)
Figure 14.14 Electrical isolation of patient leads to biopotential amplifiers (c) Simplified equivalent circuit for an optical isolator (Copyright (c) 1989 BurrBrown Corporation. Burr Brown ISO100)
15 V (Driver)
Isolation barrier
15 V (Receiver)
Freq control
Osc
3 pF Q
Q 3 pF
Figure 14.14 Electrical isolation of patient leads to biopotential amplifiers (d) Capacitively coupled isolation amplifier (Horowitz and Hill, Art of Electronics, Cambridge Univ. Press. Burr Brown ISO106).
ISOLAO EM SENSOR DE PRESSO A) Cateter condutor - distribuir a corrente de fuga por todo o corpo B) Sensor eltrico de presso isolado da soluo salina
C) Cateter com fibra ptica D) Sensores passivos e telemtricos
4 cm Clear plastic
To patient Gel Saline Flush valve IV tubing
Silicon chip
Electrical cable
Figure 14.16 Three-LED receptacle tester Ordinary silicon diodes prevent damaging reverse-LED currents, and resistors limit current. The LEDs are ON for line voltages from about 20 V rms to greater than 240 V rms, so these devices should not be used to measure line voltage.
Testes
Resistncia Neutro Terra < 0,2 W Tenso entre o aterramento e reas condutoras < 20 mV (normas aceitam at 500 mV para construes antigas)
Appliance power switch (use both OFF and ON positions) Open switch for appliances not intended to contact a patient Grounding-contact switch (use in OPEN position) H (black) H 120 V N (white) N G Polarity- reversing switch (use both positions)
Appliance
To exposed conductive surface or if none, then 10 by 20 cm metal foil in contact with the exposed surface
G (green) Building ground This connection is at service entrance or on supply side of separately derived system
I Current meter
Test circuit
< 300 uA for appliances intended for use in the patient vicinity
Figure 14.18 (a) Chassis leakage-current test. (b) Current meter circuit to be used for measuring leakage current.
Figure 14.19 Test for leakage current from patient leads to ground
Figure 14.21 Test for ac isolation current. Se aparecer a tenso da linha sobre o paciente!