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RC4194
Dual Tracking Voltage Regulators
Features
* Simultaneously adjustable outputs with one resistor to 42V * Load current - 200 mA with 0.04% load regulation * Internal thermal shutdown at TJ = +175C * External balance for VOUT unbalancing * 3W power dissipations
Description
The RC/RM4194 are dual polarity tracking regulators designed to provide balanced or unbalanced positive and negative output voltages at currents to 200 mA. A single external resistor adjustment can be used to change both outputs between the limits of 50 mV and 42V. These devices are designed for local "on-card" regulation, eliminating distribution problems associated with singlepoint regulation. To simplify application the regulators require a minimum number of external parts. The device is available in three package types to accommodate various power requirements. The K (TO-66) power package can dissipate up to 3W at TA = +25C. The D 14-pin dual in-line will dissipate up to 1W and the N 14-pin dual in-line will dissipate up to 625 mW.
Block Diagram
4194 +VOUT +VS
20K
GND
Comp+
100A Current Source
RSET
Bal
20K Comp-
Thermal Shutdown
RO -VOUT
-VS
3R
R
65-4194-01
Rev. 1.0.0
PRODUCT SPECIFICATION
RC4194
Pin Assignments
-VS (Case) +VS +VOUT NC +VOUT 6 Comp+ 7 8 Bal 9 1 5 4 3 2 RO R SET GND Comp+ Bal CompNC -V S 3 4 5 6 7 12 11 10 9 8 GND R SET RO NC -VOUT 1 2 14 +V S 13 NC
Comp-
-VOUT
65-4194-02
65-4194-03
Absolute Maximum Ratings
(beyond which the device may be damaged)1 Parameter Supply Voltage Supply Input to Output Voltage Differential Load Current RC4194 RM4194 RC4194 RM4194 PDIP CerDIP TO-66 Metal Can PDTA < 50C PDIP CerDIP TO-66 Metal Can Operating Temperature (Tj) Storage Temperature Junction Temperature PDIP CerDIP TO-66 Metal Can Lead Soldering Temperature (60 seconds) For TA > 50C Derate at TO-66 Metal Can PDIP CerDIP
Note: 1. Functional operation under any of these conditions is NOT implied.
Min
Typ
Max 35 45 35 45 100 150 250 468 1042 2381
Units V V V V mA mA mA mW mW mW C C C C C C C mW/C mW/C mW/C
RC4194 RM4194
0 -55 -65
70 125 150 125 175 150 300 23.81 6.25 8.38
2
RC4194
PRODUCT SPECIFICATION
Operating Conditions
Parameter qJC qJA Thermal Resistance Thermal Resistance CerDIP TO-66 Metal Can PDIP CerDIP TO-66 Metal Can Min Typ 60 7 160 120 42 Max Units C/W C/W C/W C/W C/W
Electrical Characteristics
(5 VOUT VMAX; -VIN -8V; IL = 1mA; RM4194: -55C Tj +125C; RC4194: 0C Tj +70C unless otherwise specified) Parameters Line Regulation Load Regulation1 Test Conditions DVS = 0.1 VIN 4194K: IL < 200 mA 4194D: IL < 100 mA VS = (VOUT + 5)V Min Typ 0.04 0.002 Max 0.1 0.004 Units %VOUT %VOUT/IL (mA)
Output Voltage Drift With Temperature2 Positive Output Negative Output Supply Current3 (Positive) VOUT = 5V VOUT = 5V VS = VMAX, VOUT = 0V, IL = 0 mA VS = VMAX, VOUT = 0V, IL = 0 mA RM4194 RC4194 Output Voltage Scale Factor Output Voltage Range RSET = 71.5 kW, Tj = +25C, VS = VMAX RM4194: RSET = 71.5 kW, IL = 25 mA RC4194: RSET = 71.5 kW, IL = 25 mA Output Voltage Tracking Ripple Rejection Input-Output Voltage Differential Short Circuit Current Output Noise Voltage Internal Thermal Shutdown
Notes: DV OUT 1. Measured as ae ------------------ 100%o I L (mA) e V OUT o 2. Output voltage temperature drift guaranteed by design. 3. The current drain will increase by 50mA/VOUT on positive side and 100mA/VOUT on negative side. 4. The specifications above apply for the given junction temperatures since pulse test conditions are used.
0.002 0.003 +0.8 -1.8 9.5 9.5 2.38 0.05 0.05 0.4 2.5
0.015 0.015 +2.5 -4.0 45 35 2.62 42 42 2.0
%/C %/C mA mA V V kW/V V V % dB V mA mVRMS C
Supply Current4 (Negative) Supply Voltage
F = 120 Hz, Tj = +25C IL = 50 mA, Tj = +25C VS = 30V, Tj = +25C CL = 4.7 mF, VOUT = 15V, F = 10 Hz to 100 kHz 3.0
70 300 250 175
3
PRODUCT SPECIFICATION
RC4194
Typical Performance Characteristics
150 Load Regulation (% VOUT/IL) Ripple Rejection (dB) 130 110 90 70 50
65-0201
0.06 0.05 0.04 0.03 0.02 0.01 0 -0.01 0 20 40 60 IL (mA) Tj = +25C
65-0202
Tj = +125C
VOUT = 15V
30 10 0 100 1K F (Hz) 10K
100K
80 100 120 140 160 180 200
Figure 1. Ripple Rejection vs. Frequency
Figure 2. Load Regulation vs. Load Current
Output Voltage Tracking (% VOUT)
0.8 0.6 0.4 0.2 0 -0.2 -0.4 C -0.6 -60 -40 -20 0 A B
65-0203
+20 +40 +60 +80 +100+120+140 Tj (C)
A = % Tracking of VOUT B = T.C. for Positive Regulator C = T.C. for Negative Regulator Figure 3. Output Voltage Tracking vs. Temperature
4
RC4194
PRODUCT SPECIFICATION
Typical Applications
0.01F +VOUT To Additional Comparators 4.7F** +VS Comp+ +VOUT RA (Typically 15 RC4805s)
+VS
RM4194 -VS -VS R SET Comp- Gnd 71.5K R0
Bal RB
4805
R0
-VOUT
-V OUT = -5V To Additional Comparators 4.7F
0.01F
R O (k1/2 ) = 2.5 (-VOUT ) Adjust R O for -VOUT = -5V (12.5 kW ) R F1 = R F2 = 20 k1/2 (See Schematic) R F1 + VOUT = -VOUT R F2 R A = when +VOUT RA RB -VOUT
65-0205
R B = when +VOUT -V OUT For +VOUT = 5 when -VOUT = -5V RA = RB =
Figure 4. Unbalanced Output Voltage -- Comparator Application
2N4905 or equiv. 0.1 mF
R SC*
2N2297 or equiv. +VS 47W +VS +VOUT GND Comp+ +V OUT 60F** 4194 -VS 47 W -VS 0.1 m F R0 2N2297 or equiv. 71.5K Load regulation 10 mV @ 2.5A R SC* 2N914 or equiv. *R SC = 0.7 I SC R O (k W) = 2.5 V O R SET CompR0 -V OUT 60F -V OUT
**Optional usage - Not as critical as -VO bypass capacitors. Note: Compensation and bypass capacitor connections should be close as posibe to the 4194
65-0206
Figure 5. High Output Application
5
PRODUCT SPECIFICATION
RC4194
Typical Applications (continued)
+VOUT = +15V 0.001F 4.7F** +VS +VS Comp+ 4194 -VS -VS R SET Comp71.5K R0 4.7F 0.001F
65-0204
To Additional Op Amps +VOUT
741 R0 -V OUT
(Typically 180 741s) -V OUT = -15V To Additional Op Amps
Gnd
R O (k1/2) = 2.5 V OUT
Figure 6. Balanced Output Voltage -- Op Amp Application
+VS = +25V 2 In Out 6 0.01F
REF-02 Gnd 4 R2 250 -VS 4.87K 14 3 Ref+ -V S RefV LC B1 CC 16 Comp DAC-08 1 IO B8 2 13 +VS IO 2R 0 R1 2.49K RC4194K VOUT = 4 I O R1 0.001 7 5 Comp + +VS +V O
6 10F
+V OUT (0 to +19.92V)
15
4 IO
3R SET NC
-VO 1 10F
-V OUT (0 to -19.92V)
5 6 7 8 9 10 11 12 MSB Binary Inputs LSB
Comp- -VS Gnd Case 4 9 0.001 -VS = -25V
Adjust R2 for -19.92V at -VOUT with all "1s" at binary inputs, then optionally adjust R3 for +19.92V at +VOUT +Vo
65-1725
6
Optional Tracking Adjustment
R3
RC4194K
Bal -Vo
8 100K 1
100K
Figure 7. Digitally Controlled Dual 200 mA Voltage Regulator
6
RC4194
PRODUCT SPECIFICATION
RC4194 Switchable Power Supply
The outputs of the RC4194 can be simultaneously switched on or off under logic control as shown in Figure 8. In the "off" state, the outputs will be forced to a minimum voltage, or about 20 mV, rather than becoming open-circuit. The turn-on time, with the outputs programmed to 12V, is approximately 200 mS. This circuit works by forcing the R0 pin to ground with an analog switch. Refer to the RC4194 internal schematic diagram. A reference voltage that regulates with respect to -VS is generated at the RSET pin by the zener diode Q12 and the buffer circuit of Q11 and Q13. When the external 71.5k RSET resistor is connected between the RSET pin and -VS, a precision current of 100 mA is generated which then flows into Q13's collector. Since Q13's collector is tied to the R0 pin, the 100 mA current will develop a ground-referenced voltage drop proportional to the value of R0, which is then amplified by the internal error amplifier. When the analog switch in Figure 8 turns on, it effectively shorts out R0 and causes 0V to be applied to the error amplifier. The output voltage in the off state will be approxi-mately 20 mV. If a higher value (50 to 100 mV) is acceptable, then the DG201 analog switch can be replaced with a low-cost small signal transistor, as shown in the alternate switch configuration.
Compensation
For most applications, the following compensation technique is sufficient. The positive regulator section of the RC4194 is compensated by a 0.001 mF ceramic disc capacitor from the Comp+ terminal to ground. The negative regulator requires compensation at two points. The first is the Comp- pin, which should have 0.001 mF to the -VS pin, or case. A ceramic disc is ideal here. The second compen-sation point for the negative side is the -VOUT terminal, which ideally should be a 4.7 mF solid tantalum capacitor with enough reserve voltage capacity to avoid the momentary shorting and reforming which can occur with tantalum caps. For systems where the cost of a solid tantalum capacitor cannot be justified, it is usually sufficient to use an aluminum capacitor with a 0.03 mF ceramic disc in parallel to bypass high frequencies. In addition, if the rectifier filter capacitors have poor high frequency characteristics (like aluminum electrolytics) or if any impedance is in series with the +VS and -VS terminals, it is necessary to bypass these two points with 0.01 mF ceramic disc capacitors. Just as with monolithic op amps, some applications may not require these bypass caps, but if in doubt, be sure to include them.
C 0.001 F +VS +VS Comp- 0.001 m F 4194 -VS RSET RSET 71.5K R0 Gnd -VOUT 4.7 F -12V Comp+ +VOUT 4.7 F +12V
-VS
+VS
-VS DG201 * Gnd
R0 30K
* Alternate Switch Configuration 4194 R0
Logic
47K 2N3904 30K
*Quad SPST CMOS Analog Switch
65-4083
Figure 8. 12V Switchable Power Supply
7
PRODUCT SPECIFICATION
RC4194
All compensation and bypass caps should have short leads, solid grounds, and be located as close to the 4194 as possible. Refer to Figure 9 for recommended compensation circuitry.
0.001F Comp+ 4194 -VS R0 -VOUT RSET Comp4.7F R0 RSET * -VOUT
+VS 0.01F -VS
+VS
+VOUT
+VOUT
Protection
In systems using monolithic voltage regulators, a number of conditions can exist which, left uncorrected, will destroy the regulator. Fortunately, regulators can easily be protected against these potentially destructive conditions. Monolithic regulators can be destroyed by any reversal of input or output voltage polarity, or if the input voltage drops below the output voltage in magnitude. These conditions can be caused by inductive loads at the inputs or outputs of the regulator. Other problems are caused by heavy loads at the unregulated inputs to the regulator, which might cause the input voltage to drop below the output voltage at turn-off. If any of the preceding problem conditions are present in your system, it is recommended that you protect the regulator using diodes. These diodes should be high speed types capable of handling large current surges. Figure 10 shows all six of the possible protection diodes. The diodes at the inputs and outputs prevent voltages at those points from becoming reversed. Diodes from outputs to inputs prevent the output voltage from exceeding the input voltage. Chances are that the system under consideration will not require all six diodes, but if in doubt, be sure to include them.
0.001F 0.01F Note: All Capacitors are Ceramic Disc Except * = Solid Tantalum
65-4201
Figure 9. RC4194 Recommended Compensation
Sometimes occasions arise in which the RC4194 ratings must be exceeded. One example is the "brownout." During a brownout, line voltages may be reduced to as low as 75 VRMS, causing the input voltage to the RC4194 to drop below the minimum dropout voltage. When this happens, the negative output voltage can go to positive. The maximum amount of current available is approximately 5 mA. In general this is not enough current to damage most ICs which the RC4194 might be supplying, but it is a potentially destructive condition. Fortunately, it is easy to protect against. As shown in the typical application circuit in Figure 11, a diode, D, can be connected to the negative output.
Brownout Protection
The RC4194 is one of the most easily applied and troublefree monolithic ICs available. When used within the data sheet ratings (package power dissipation, maximum output current, minimum and maximum input voltages) it provides the most cost-effective source of regulated 15V for powering linear ICs.
0.001F +VS 0.01F +VS Comp+ +VOUT +VOUT
4194 -VS R 0 -V OUT RSET Comp4.7F * R0 R SET 0.001 F -V OUT
-VS
To -V OUT 0.01F
Note: All Capacitors are Ceramic Disc Except * = Solid Tantalum
65-4202
Figure 10. RC4194 Regulator Showing All Protective Diodes
8
RC4194
PRODUCT SPECIFICATION
If a small signal silicon diode is used, it will clamp the negative output voltage at about +0.55V. A Schottky barrier or germanium device would clamp the voltage at about +0.3V. Another cure which will keep the negative output negative at all times is the 1 mW resistor connected between the +15V output and the Comp- terminal. This resistor will then supply drive to the negative output transistor, causing it to saturate to -1V during the brownout.
Let's look at an application where a user is trying to determine whether the RC4194 in a high temperature environment will need a heatsink. Given: TJ at thermal shutdown = 150C TA = 125C qJ-A = 41.6C/W, K (TO-66) pkg. VIN = 40V VOUT = 30V IQ = 1 mA + 75 mA/VOUT x 30V = 3.25 mA*
TJ - TA q J - A = -----------------PD TJ - TA P D = -----------------qJ - A = ( V IN - V OUT ) I O + V IN I Q
Heatsinking
Voltage Regulators are power devices which are used in a wide range of applications. When operating these devices near their extremes of load current, ambient temperature and input-output differential, consideration of package dissipation becomes important to avoid thermal shutdown at 175C. The RC4194 has this feature to prevent damage to the device. It typically starts affecting load regulation approximately 2C below 175C. To avoid shutdown, some form of heatsinking should be used or one of the above operating conditions would need to be derated.* The following is the basic equation for junction temperature:
TJ = TA + PD qJ - A Equation 1
Solve for IO,
V IN I Q TJ - TA I O = ------------------------------------------------ - ---------------------------------q J - A ( V IN - V OUT ) ( V IN - V OUT ) 150C - 125C 40 3.25 10 I O = ---------------------------------------- - --------------------------------------41.6C/W 10V 10
-3
where TJ = junction temperature (C) TA = ambient air temperature (C) PD = power dissipated by device (W) qJ-A = thermal resistance from junction to ambient air (C/W) The power dissipated by the voltage regulator can be detailed as follows:
P D = ( V IN - V OUT ) I O + V IN I Q Equation 2
= 60 mA - 13 mA ~ 47 mA If this supply current does not provide at least a 10% margin under worst case load conditions, heatsinking should be employed. If reliability is of prime importance, the multiple regulator approach should be considered. In Equation 1, qJ-A can be broken into the following components: qJ-A = qJ-C + qC-S + qS-A where qJ-C = junction-to-case thermal resistance qC-S = case-to-heatsink thermal resistance qS-A = heatsink-to-ambient thermal resistance
where VIN = input voltage VOUT = regulated output voltage IO = load current IQ = quiescent current drain
------------------------------ *The current drain will increase by 50mA/VOUT on positive side and 100mA/VOUT on negative side
9
PRODUCT SPECIFICATION
RC4194
In the above example, let's say that the user's load current is 200 mA and he wants to calculate the combined qC-S and qS-A he needs: Given: IO = 200 mA,
TJ - TA q J - A = -------------------------------------------------------------------------( V IN - V OUT ) I O + V IN I Q 50C - 125C = ---------------------------------------------------------------------------------3 10V 200mA + 40 3.25 10
Given qJ-C = 7.15C/W for the 4194 in the K package, qC-S + qS-A = 11.75C/W - 7.15C/W = 4.6C/W When using heatsink compound with a metal-to-metal interface, a typical qC-S = 0.5C/W for the K package. The remaining qS-A of approximately 4C/W is a large enough thermal resistance to be easily provided by a number of heatsinks currently available. Table 1 is a brief selection guide to heatsink manufacturers.
= 11.75C/W
Table 1. Commercial Heatsink Selection Guide
No attempt has been made to provide a complete list of all heatsink manufacturers. This list is only representative. qS-A1(C/W) 0.31 - 1.0 1.0 - 3.0 3.0 - 5.0 Manufacturer/Series or Part Number TO-66 Package Thermalloy -- 6441, 6443, 6450, 6470, 6560, 6590, 6660, 6690 Wakefield -- 641 Thermalloy -- 6123, 6135, 6169, 6306, 6401, 6403, 6421, 6423, 6427, 6442, 6463, 6500 Wakefield -- 621, 623 Thermalloy -- 6606, 6129, 6141, 6303 IERC -- HP Staver -- V3-3-2 5.0 - 7.0 Wakefield -- 690 Thermalloy -- 6002, 6003, 6004, 6005, 6052, 6053, 6054, 6176, 6301 IERC -- LB Staver-- V3-5-2 7.0 - 10.0 Wakefield -- 672 Thermalloy -- 6001, 6016, 6051, 6105, 6601 IERC -- LA, uP Staver -- V1-3, V1-5, V3-3, V3-5, V3-7 10.0 - 25.0 20 30 32 34 45 60 Thermalloy -- 6-13, 6014, 6015, 6103, 6104, 6105, 6117 Dual In-line Package Thermalloy -- 6007 Thermalloy -- 6010 Thermalloy -- 6011 Thermalloy -- 6012 IERC -- LI Wakefield -- 650, 651
Staver Co., Inc.: 41-51 N Saxon Ave., Bay Shore, NY 11706 IERC: 135 W Magnolia Blvd., Burbank, CA 91502 Thermalloy: P.O. Box 34829, 2021 W Valley View Ln., Dallas, TX Wakefield Engin Ind: Wakefield, MA 01880 * All values are typical as given by manufacturer or as determined from characteristic curves supplied by manufacturer.
10
RC4194
Comp+ (7) +Vs (5) Q28 Q38 Q40 Q32 Q35 R19 3000 Q36 Q33 Q36 R20 200 Q42 R21 1.1 -VOUT (6) R23 20K Q34 Q37 R24 20K Q44 R8 5000 Q16 Q20 R9 15K Q45 (1) Q25 C1 10 pF Q12 R6 30K Q8 Q23 Q22 R3 5000 R7 5000 R11 3900 R10 1650 Q19 Q24 Q46 Q18 Q43 R14 3000 W R15 1.1 W 200W 8 kW Q26 Q27 -VOUT Q7 Q10 Q9 Q13 Q11 Q17 Q21 Q31 Bal RF2 R18 10K Q47 (4) Gnd RF1 Q41 Q30
Q29
Simplified Schematic Diagram
(8)
Q1
R4 500
R5 25K
Q3
Q4
Q2
R1 12K
Q6
Q5
R2 680
PRODUCT SPECIFICATION
Note: Pin numbers are for K package.
(3) RSET
(2) R0
-VS To Case
(9) Comp-
65-0198
11
PRODUCT SPECIFICATION
RC4194
Mechanical Dimensions
9-Lead Metal Can IC Header Package
oD oD1 A ob oD oD1 e e1 F op q r1 r2 S Notes: 1. All leads--increase maximum limit by .003 (.08mm) when lead finish is applied. e1 op Inches Min. .250 .028 -- .470 .190 .093 .050 .360 .142 .958 -- -- .570 Max. .340 .034 .620 .500 .210 .107 .075 -- .152 .962 .350 .145 .590 Millimeters Min. 6.35 .71 -- 11.94 4.83 2.36 1.27 9.14 3.61 24.33 -- -- 14.48 Max. 8.64 .86 15.75 12.70 5.33 2.72 1.91 -- 3.86 24.43 8.89 3.68 14.99 1
Symbol
Notes
A
F
ob
S
e
r2
r1 q
12
RC4194
PRODUCT SPECIFICATION
Mechanical Dimensions (continued)
14-Lead Ceramic DIP Package
Inches Min. A b1 b2 c1 D E e eA L Q s1 a Max. Millimeters Min. Max. 8 2 8 4 4 5, 9 7 3 6 Notes: Notes 1. Index area: a notch or a pin one identification mark shall be located adjacent to pin one. The manufacturer's identification shall not be used as pin one identification mark. 2. The minimum limit for dimension "b2" may be .023 (.58mm) for leads number 1, 7, 8 and 14 only. 3. Dimension "Q" shall be measured from the seating plane to the base plane. 4. This dimension allows for off-center lid, meniscus and glass overrun. 5. The basic pin spacing is .100 (2.54mm) between centerlines. Each pin centerline shall be located within .010 (.25mm) of its exact longitudinal position relative to pins 1 and 14. 6. Applies to all four corners (leads number 1, 7, 8, and 14). 7. "eA" shall be measured at the center of the lead bends or at the centerline of the leads when "a" is 90. 8. All leads - Increase maximum limit by .003 (.08mm) measured at the center of the flat, when lead finish applied. 9. Twelve spaces. D
7 1
Symbol
-- .200 .014 .023 .045 .065 .008 .015 -- .785 .220 .310 .100 BSC .300 BSC .125 .200 .015 .060 .005 -- 90 105
-- 5.08 .36 .58 1.14 1.65 .20 .38 -- 19.94 5.59 7.87 2.54 BSC 7.62 BSC 3.18 5.08 .38 1.52 .13 -- 90 105
NOTE 1
E
8
14
s1 eA
e
A Q L b2 b1 a c1
13
PRODUCT SPECIFICATION
RC4194
Mechanical Dimensions (continued)
14-Lead Plastic DIP Package
Inches Min. A A1 A2 B B1 C D D1 E E1 e eB L N -- .015 .115 Max. .210 -- .195 Millimeters Min. -- .38 2.93 Max. 5.33 -- 4.95 Notes: Notes 1. Dimensioning and tolerancing per ANSI Y14.5M-1982. 2. "D" and "E1" do not include mold flashing. Mold flash or protrusions shall not exceed .010 inch (0.25mm). 3. Terminal numbers are shown for reference only. 4. "C" dimension does not include solder finish thickness. 5. Symbol "N" is the maximum number of terminals. 4 2
Symbol
.014 .022 .045 .070 .008 .015 .725 .795 .005 -- .300 .325 .240 .280 .100 BSC -- .430 .115 .200 14
.36 .56 1.14 1.78 .20 .38 18.42 20.19 .13 -- 7.62 8.26 6.10 7.11 2.54 BSC -- 10.92 2.92 5.08 14
2
5
D 7 1
E1
D1
8
14
E e A A1 L B1 B eB C
14
PRODUCT SPECIFICATION
RC4194
Ordering Information
Product Number RC4194N RC4194D RC4194K RM4194D RM4194D/883B RM4194K Temperature Range 0 to +70C 0 to +70C 0 to +70C -55C to +125C -55C to +125C -55C to +125C Screening Commercial Commercial Commercial Commercial Military Commercial Package 14 pin Plastic DIP 14 pin Ceramic DIP 9 pin TO-66 14 pin Ceramic DIP 14 pin Ceramic DIP 9 pin TO-66 7705401CA SMD Number
Note: 1. /883B suffix denotes MIL-STD-883, Par. 1.2.1 compliant device.
LIFE SUPPORT POLICY FAIRCHILD'S PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL COMPONENTS IN LIFE SUPPORT DEVICES OR SYSTEMS WITHOUT THE EXPRESS WRITTEN APPROVAL OF THE PRESIDENT OF FAIRCHILD SEMICONDUCTOR CORPORATION. As used herein: 1. Life support devices or systems are devices or systems which, (a) are intended for surgical implant into the body, or (b) support or sustain life, and (c) whose failure to perform when properly used in accordance with instructions for use provided in the labeling, can be reasonably expected to result in a significant injury of the user.
www.fairchildsemi.com 5/20/98 0.0m 001 Stock#DS30004194 O 1998 Fairchild Semiconductor Corporation
2. A critical component in any component of a life support device or system whose failure to perform can be reasonably expected to cause the failure of the life support device or system, or to affect its safety or effectiveness.

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