LM7171
Very High Speed, High Output Current, Voltage
Feedback Amplifier
LM7171 Very High Speed, High Output Current, Voltage Feedback Amplifier
May 2006
General Description
The LM7171 is a high speed voltage feedback amplifier that
has the slewing characteristic of a current feedback amplifier; yet it can be used in all traditional voltage feedback
amplifier configurations. The LM7171 is stable for gains as
low as +2 or −1. It provides a very high slew rate at 4100V/µs
and a wide unity-gain bandwidth of 200 MHz while consuming only 6.5 mA of supply current. It is ideal for video and
high speed signal processing applications such as HDSL
and pulse amplifiers. With 100 mA output current, the
LM7171 can be used for video distribution, as a transformer
driver or as a laser diode driver.
±
Operation on
swings and provides greater dynamic range and signal-tonoise ratio. The LM7171 offers low SFDR and THD, ideal for
ADC/DAC systems. In addition, the LM7171 is specified for
±
5V operation for portable applications.
The LM7171 is built on National’s advanced VIP
cally integrated PNP) complementary bipolar process.
15V power supplies allows for large signal
™
III (Verti-
Typical Performance
Large Signal Pulse Response
= +2, VS=±15V
A
V
Features
(Typical Unless Otherwise Noted)
n Easy-to-use voltage feedback topology
n Very high slew rate: 4100 V/µs
n Wide unity-gain bandwidth: 200 MHz
n −3 dB frequency
n Low supply current: 6.5 mA
n High open loop gain: 85 dB
n High output current: 100 mA
n Differential gain and phase: 0.01%, 0.02˚
n Specified for
@
AV= +2: 220 MHz
±
15V and±5V operation
Applications
n HDSL and ADSL drivers
n Multimedia broadcast systems
n Professional video cameras
n Video amplifiers
n Copiers/scanners/fax
n HDTV amplifiers
n Pulse amplifiers and peak detectors
n CATV/fiber optics signal processing
01238501
VIP™is a trademark of National Semiconductor Corporation.
© 2006 National Semiconductor Corporation DS012385 www.national.com
Absolute Maximum Ratings (Note 1)
If Military/Aerospace specified devices are required,
LM7171
please contact the National Semiconductor Sales Office/
Distributors for availability and specifications.
Maximum Junction Temperature
(Note 4) 150˚C
Operating Ratings (Note 1)
ESD Tolerance (Note 2) 2.5 kV
+–V−
Supply Voltage (V
Differential Input Voltage (Note 11)
) 36V
±
10V
Output Short Circuit to Ground
(Note 3) Continuous
Storage Temperature Range −65˚C to +150˚C
Supply Voltage 5.5V ≤ V
Junction Temperature Range
LM7171AI, LM7171BI −40˚C ≤ T
Thermal Resistance (θ
)
JA
8-Pin MDIP 108˚C/W
8-Pin SOIC 172˚C/W
±
15V DC Electrical Characteristics
Unless otherwise specified, all limits guaranteed for TJ= 25˚C, V+= +15V, V−= −15V, VCM= 0V, and RL=1kΩ. Boldface
limits apply at the temperature extremes
Symbol Parameter Conditions Typ
(Note 5)
LM7171AI LM7171BI Units
Limit Limit
(Note 6) (Note 6)
V
OS
Input Offset Voltage 0.2 1 3 mV
47max
TC V
OS
Input Offset Voltage 35 µV/˚C
Average Drift
I
B
Input Bias Current 2.7 10 10 µA
12 12 max
I
OS
Input Offset Current 0.1 4 4 µA
66max
R
IN
Input Resistance Common Mode 40 MΩ
Differential Mode 3.3
R
O
Open Loop Output 15 Ω
Resistance
CMRR Common Mode V
=±10V 105 85 75 dB
CM
Rejection Ratio 80 70 min
PSRR Power Supply V
=±15V to±5V 90 85 75 dB
S
Rejection Ratio 80 70 min
V
CM
Input Common-Mode CMRR>60 dB
±
13.35 V
Voltage Range
A
V
Large Signal Voltage RL=1kΩ 85 80 75 dB
Gain (Note 7) 75 70 min
R
= 100Ω 81 75 70 dB
L
70 66 min
V
O
Output Swing RL=1kΩ 13.3 13 13 V
12.7 12.7 min
−13.2 −13 −13 V
−12.7 −12.7 max
R
= 100Ω 11.8 10.5 10.5 V
L
9.5 9.5 min
−10.5 −9.5 −9.5 V
−9 −9 max
Output Current Sourcing, R
= 100Ω 118 105 105 mA
L
(Open Loop) 95 95 min
(Note 8) Sinking, R
= 100Ω 105 95 95 mA
L
90 90 max
≤ 36V
S
≤ +85˚C
J
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±
15V DC Electrical Characteristics (Continued)
Unless otherwise specified, all limits guaranteed for TJ= 25˚C, V+= +15V, V−= −15V, VCM= 0V, and RL=1kΩ. Boldface
limits apply at the temperature extremes
Symbol Parameter Conditions Typ
(Note 5)
LM7171AI LM7171BI Units
Limit Limit
(Note 6) (Note 6)
Output Current Sourcing, R
(in Linear Region) Sinking, R
I
SC
Output Short Circuit Sourcing 140 mA
= 100Ω 100 mA
L
= 100Ω 100
L
Current Sinking 135
I
S
Supply Current 6.5 8.5 8.5 mA
9.5 9.5 max
±
15V AC Electrical Characteristics
Unless otherwise specified, TJ= 25˚C, V+= +15V, V−= −15V, VCM= 0V, and RL=1kΩ.
Typ LM7171AI LM7171BI
Symbol Parameter Conditions (Note 5) Limit Limit Units
(Note 6) (Note 6)
SR Slew Rate (Note 9) A
= +2, VIN=13V
V
A
= +2, VIN=10V
V
PP
PP
4100 V/µs
3100
Unity-Gain Bandwidth 200 MHz
−3 dB Frequency A
φ
m
t
s
t
p
A
D
φ
D
Phase Margin 50 Deg
Settling Time (0.1%) AV= −1, VO=±5V 42 ns
Propagation Delay AV= −2, VIN=±5V, 5 ns
Differential Gain (Note 10) 0.01 %
Differential Phase (Note 10) 0.02 Deg
Second Harmonic (Note 12) f
Third Harmonic (Note 12) f
e
n
Input-Referred f = 10 kHz
= +2 220 MHz
V
R
= 500Ω
L
R
= 500Ω
L
= 10 kHz −110 dBc
IN
f
= 5 MHz −75 dBc
IN
= 10 kHz −115 dBc
IN
f
= 5 MHz −55 dBc
IN
14
Voltage Noise
i
n
Input-Referred f = 10 kHz
1.5
Current Noise
LM7171
±
5V DC Electrical Characteristics
Unless otherwise specified, all limits guaranteed for TJ= 25˚C, V+= +5V, V−= −5V, VCM= 0V, and RL=1kΩ. Boldface limits
apply at the temperature extremes
Typ LM7171AI LM7171BI
Symbol Parameter Conditions (Note 5) Limit Limit Units
(Note 6) (Note 6)
V
OS
Input Offset Voltage 0.3 1.5 3.5 mV
47max
TC V
OS
Input Offset Voltage 35 µV/˚C
Average Drift
I
B
Input Bias Current 3.3 10 10 µA
12 12 max
I
OS
Input Offset Current 0.1 4 4 µA
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±
5V DC Electrical Characteristics (Continued)
Unless otherwise specified, all limits guaranteed for TJ= 25˚C, V+= +5V, V−= −5V, VCM= 0V, and RL=1kΩ. Boldface limits
LM7171
apply at the temperature extremes
Typ LM7171AI LM7171BI
Symbol Parameter Conditions (Note 5) Limit Limit Units
(Note 6) (Note 6)
66max
R
IN
Input Resistance Common Mode 40 MΩ
Differential Mode 3.3
R
O
CMRR Common Mode V
Output Resistance 15 Ω
=±2.5V 104 80 70 dB
CM
Rejection Ratio 75 65 min
PSRR Power Supply V
=±15V to±5V 90 85 75 dB
S
Rejection Ratio 80 70 min
V
CM
Input Common-Mode CMRR>60 dB
±
3.2 V
Voltage Range
A
V
Large Signal Voltage RL=1kΩ 78 75 70 dB
Gain (Note 7) 70 65 min
R
= 100Ω 76 72 68 dB
L
67 63 min
V
O
Output Swing RL=1kΩ 3.4 3.2 3.2 V
33min
−3.4 −3.2 −3.2 V
−3 −3 max
R
= 100Ω 3.1 2.9 2.9 V
L
2.8 2.8 min
−3.0 −2.9 −2.9 V
−2.8 −2.8 max
Output Current Sourcing, R
= 100Ω 31 29 29 mA
L
(Open Loop) (Note 8) 28 28 min
Sinking, R
= 100Ω 30 29 29 mA
L
28 28 max
I
SC
Output Short Circuit Sourcing 135 mA
Current Sinking 100
I
S
Supply Current 6.2 8 8 mA
99max
±
5V AC Electrical Characteristics
Unless otherwise specified, TJ= 25˚C, V+= +5V, V−= −5V, VCM= 0V, and RL=1kΩ.
Typ LM7171AI LM7171BI
Symbol Parameter Conditions (Note 5) Limit Limit Units
(Note 6) (Note 6)
SR Slew Rate (Note 9) A
= +2, VIN= 3.5 V
V
PP
950 V/µs
Unity-Gain Bandwidth 125 MHz
−3 dB Frequency A
φ
m
t
s
t
p
A
D
φ
D
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Phase Margin 57 Deg
Settling Time (0.1%) AV= −1, VO=±1V, 56 ns
Propagation Delay AV= −2, VIN=±1V, 6 ns
Differential Gain (Note 1) 0.02 %
Differential Phase (Note 10) 0.03 Deg
= +2 140 MHz
V
R
= 500Ω
L
R
= 500Ω
L
±
5V AC Electrical Characteristics (Continued)
Unless otherwise specified, TJ= 25˚C, V+= +5V, V−= −5V, VCM= 0V, and RL=1kΩ.
Typ LM7171AI LM7171BI
Symbol Parameter Conditions (Note 5) Limit Limit Units
(Note 6) (Note 6)
Second Harmonic (Note 12) f
Third Harmonic (Note 12) f
e
n
Input-Referred f = 10 kHz 14
= 10 kHz −102 dBc
IN
f
= 5 MHz −70 dBc
IN
= 10 kHz −110 dBc
IN
f
= 5 MHz −51 dBc
IN
Voltage Noise
i
n
Input-Referred f = 10 kHz
1.8
Current Noise
Note 1: Absolute Maximum Ratings indicate limits beyond which damage to the device may occur. Operating Ratings indicate conditions for which the device is
intended to be functional, but specific performance is not guaranteed. For guaranteed specifications and the test conditions, see the Electrical Characteristics.
Note 2: Human body model, 1.5 kΩ in series with 100 pF.
Note 3: Applies to both single-supply and split-supply operation. Continuous short circuit operation at elevated ambient temperature can result in exceeding the
maximum allowed junction temperature of 150˚C.
Note 4: The maximum power dissipation is a function of T
(T
Note 5: Typical values represent the most likely parametric norm.
Note 6: All limits are guaranteed by testing or statistical analysis.
Note 7: Large signal voltage gain is the total output swing divided by the input signal required to produce that swing. For V
V
OUT
Note 8: The open loop output current is guaranteed, by the measurement of the open loop output voltage swing, using 100Ω output load.
Note 9: Slew Rate is the average of the raising and falling slew rates.
Note 10: Differential gain and phase are measured with A
Note 11: Input differential voltage is applied at V
Note 12: Harmonics are measured with V
Note 13: The THD measurement at low frequency is limited by the test instrument.
)/θJA. All numbers apply for packages soldered directly into a PC board.
J(MAX)–TA
=±1V.
=±15V.
S
=1VPP,AV= +2 and RL= 100Ω.
IN
, θJA, and TA. The maximum allowable power dissipation at any ambient temperature is PD=
J(MAX)
=±15V, V
S
= +2, VIN=1VPPat 3.58 MHz and both input and output 75Ω terminated.
V
=±5V. For VS=±5V,
OUT
LM7171
Connection Diagram
8-Pin DIP/SO
Top View
01238502
Ordering Information
Package Temperature Range Transport
Industrial Military
−40˚C to +85˚C −55˚C to +125˚C
LM7171AIM Rails
8-Pin SOIC
8-Pin MDIP
LM7171AIMX Tape and Reel
LM7171BIM Rails
LM7171BIMX Tape and Reel
LM7171AIN Rails
LM7171BIN Rails
Media
NSC
Drawing
M08A
N08E
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Typical Performance Characteristics unless otherwise noted, T
LM7171
Supply Current vs. Supply Voltage Supply Current vs. Temperature
01238563 01238564
Input Offset Voltage vs. Temperature Input Bias Current vs. Temperature
= 25˚C
A
01238565
01238566
Short Circuit Current vs. Temperature (Sourcing) Short Circuit Current vs. Temperature (Sinking)
01238567
01238568
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LM7171
Typical Performance Characteristics unless otherwise noted, T
Output Voltage vs. Output Current Output Voltage vs. Output Current
01238569 01238570
CMRR vs. Frequency PSRR vs. Frequency
= 25˚C (Continued)
A
01238571 01238572
PSRR vs. Frequency Open Loop Frequency Response
01238573
01238551
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Typical Performance Characteristics unless otherwise noted, T
LM7171
Open Loop Frequency Response Gain-Bandwidth Product vs. Supply Voltage
= 25˚C (Continued)
A
01238552
Gain-Bandwidth Product vs. Load Capacitance Large Signal Voltage Gain vs. Load
01238554
Large Signal Voltage Gain vs. Load Input Voltage Noise vs. Frequency
01238553
01238555
01238556
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01238557
Typical Performance Characteristics unless otherwise noted, T
LM7171
Open Loop Output Impedance vs. Frequency Open Loop Output Impedance vs Frequency
01238525 01238526
Large Signal Pulse Response
= −1, VS=±15V
A
V
= 25˚C (Continued)
A
Large Signal Pulse Response
AV= −1, VS=±5V
Large Signal Pulse Response
= +2, VS=±15V
A
V
01238527 01238528
Large Signal Pulse Response
AV= +2, VS=±5V
01238529 01238530
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LM7171
Typical Performance Characteristics unless otherwise noted, T
Small Signal Pulse Response
A
= −1, VS=±15V
V
Small Signal Pulse Response
= +2, VS=±15V
A
V
01238531 01238532
Small Signal Pulse Response
Small Signal Pulse Response
= 25˚C (Continued)
A
AV= −1, VS=±5V
AV= +2, VS=±5V
01238533 01238534
Closed Loop Frequency Response vs. Supply Voltage
= +2)
(A
V
01238535 01238536
Closed Loop Frequency Response vs. Capacitive Load
(AV= +2)
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Typical Performance Characteristics unless otherwise noted, T
LM7171
Closed Loop Frequency Response vs. Capacitive Load
(A
= +2)
V
01238537 01238538
Closed Loop Frequency Response vs. Input Signal Level
= +2)
(A
V
Closed Loop Frequency Response vs. Input Signal Level
Closed Loop Frequency Response vs. Input Signal Level
= 25˚C (Continued)
A
(AV= +2)
(AV= +2)
01238543 01238539
Closed Loop Frequency Response vs. Input Signal Level
= +2)
(A
V
01238540 01238544
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Closed Loop Frequency Response vs. Input Signal Level
(AV= +4)
LM7171
Typical Performance Characteristics unless otherwise noted, T
Closed Loop Frequency Response vs. Input Signal Level
(A
= +4)
V
01238545 01238541
Closed Loop Frequency Response vs. Input Signal Level
= +4) Total Harmonic Distortion vs. Frequency (Note 13)
(A
V
Closed Loop Frequency Response vs. Input Signal Level
= 25˚C (Continued)
A
(AV= +4)
01238542
01238546
Total Harmonic Distortion vs. Frequency (Note 13) Undistorted Output Swing vs. Frequency
01238547
01238549
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Typical Performance Characteristics unless otherwise noted, T
LM7171
Undistorted Output Swing vs. Frequency Undistorted Output Swing vs. Frequency
= 25˚C (Continued)
A
01238548
Harmonic Distortion vs. Frequency (Note 13) Harmonic Distortion vs. Frequency (Note 13)
01238574 01238575
Maximum Power Dissipation vs. Ambient Temperature
01238550
01238520
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Simplified Schematic Diagram
LM7171
Note: M1 and M2 are current mirrors.
01238509
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Application Notes
LM7171
PERFORMANCE DISCUSSION
The LM7171 is a very high speed, voltage feedback amplifier. It consumes only 6.5 mA supply current while providing
a unity-gain bandwidth of 200 MHz and a slew rate of
4100V/µs. It also has other great features such as low
differential gain and phase and high output current.
The LM7171 is a true voltage feedback amplifier. Unlike
current feedback amplifiers (CFAs) with a low inverting input
impedance and a high non-inverting input impedance, both
inputs of voltage feedback amplifiers (VFAs) have high impedance nodes. The low impedance inverting input in CFAs
and a feedback capacitor create an additional pole that will
lead to instability. As a result, CFAs cannot be used in
traditional op amp circuits such as photodiode amplifiers,
I-to-V converters and integrators where a feedback capacitor
is required.
CIRCUIT OPERATION
The class AB input stage in LM7171 is fully symmetrical and
has a similar slewing characteristic to the current feedback
amplifiers. In the LM7171 Simplified Schematic, Q1 through
Q4 form the equivalent of the current feedback input buffer,
the equivalent of the feedback resistor, and stage A
R
E
buffers the inverting input. The triple-buffered output stage
isolates the gain stage from the load to provide low output
impedance.
SLEW RATE CHARACTERISTIC
The slew rate of LM7171 is determined by the current available to charge and discharge an internal high impedance
node capacitor. This current is the differential input voltage
divided by the total degeneration resistor R
slew rate is proportional to the input voltage level, and the
higher slew rates are achievable in the lower gain configurations. A curve of slew rate versus input voltage level is
provided in the “Typical Performance Characteristics”.
When a very fast large signal pulse is applied to the input of
an amplifier, some overshoot or undershoot occurs. By placing an external resistor such as 1 kΩ in series with the input
of LM7171, the bandwidth is reduced to help lower the
overshoot.
SLEW RATE LIMITATION
If the amplifier’s input signal has too large of an amplitude at
too high of a frequency, the amplifier is said to be slew rate
limited; this can cause ringing in time domain and peaking in
frequency domain at the output of the amplifier.
In the “Typical Performance Characteristics” section, there
are several curves of A
signal levels. For the A
= +2 and AV= +4 versus input
V
= +4 curves, no peaking is present
V
and the LM7171 responds identically to the different input
signal levels of 30 mV, 100 mV and 300 mV.
For the A
peaking at high frequency (
= +2 curves, with slight peaking occurs. This
V
>
100 MHz) is caused by a large
input signal at high enough frequency that exceeds the
amplifier’s slew rate. The peaking in frequency response
does not limit the pulse response in time domain, and the
LM7171 is stable with noise gain of ≥+2.
. Therefore, the
E
LAYOUT CONSIDERATION
Printed Circuit Board and High Speed Op Amps
There are many things to consider when designing PC
boards for high speed op amps. Without proper caution, it is
very easy to have excessive ringing, oscillation and other
degraded AC performance in high speed circuits. As a rule,
the signal traces should be short and wide to provide low
inductance and low impedance paths. Any unused board
space needs to be grounded to reduce stray signal pickup.
Critical components should also be grounded at a common
point to eliminate voltage drop. Sockets add capacitance to
the board and can affect high frequency performance. It is
better to solder the amplifier directly into the PC board
without using any socket.
Using Probes
Active (FET) probes are ideal for taking high frequency
measurements because they have wide bandwidth, high
input impedance and low input capacitance. However, the
probe ground leads provide a long ground loop that will
produce errors in measurement. Instead, the probes can be
grounded directly by removing the ground leads and probe
jackets and using scope probe jacks.
Component Selection and Feedback Resistor
It is important in high speed applications to keep all component leads short. For discrete components, choose carbon
composition-type resistors and mica-type capacitors. Surface mount components are preferred over discrete components for minimum inductive effect.
Large values of feedback resistors can couple with parasitic
capacitance and cause undesirable effects such as ringing
or oscillation in high speed amplifiers. For LM7171, a feedback resistor of 510Ω gives optimal performance.
COMPENSATION FOR INPUT CAPACITANCE
The combination of an amplifier’s input capacitance with the
gain setting resistors adds a pole that can cause peaking or
oscillation. To solve this problem, a feedback capacitor with
a value
>
(RGxCIN)/R
C
F
F
can be used to cancel that pole. For LM7171, a feedback
capacitor of 2 pF is recommended. Figure 1 illustrates the
compensation circuit.
01238510
FIGURE 1. Compensating for Input Capacitance
POWER SUPPLY BYPASSING
Bypassing the power supply is necessary to maintain low
power supply impedance across frequency. Both positive
and negative power supplies should be bypassed individu-
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Application Notes (Continued)
ally by placing 0.01 µF ceramic capacitors directly to power
supply pins and 2.2 µF tantalum capacitors close to the
power supply pins.
01238511
FIGURE 2. Power Supply Bypassing
TERMINATION
In high frequency applications, reflections occur if signals
are not properly terminated. Figure 3 shows a properly terminated signal while Figure 4 shows an improperly terminated signal.
LM7171
To minimize reflection, coaxial cable with matching characteristic impedance to the signal source should be used. The
other end of the cable should be terminated with the same
value terminator or resistor. For the commonly used cables,
RG59 has 75Ω characteristic impedance, and RG58 has
50Ω characteristic impedance.
DRIVING CAPACITIVE LOADS
Amplifiers driving capacitive loads can oscillate or have ringing at the output. To eliminate oscillation or reduce ringing,
an isolation resistor can be placed as shown below in Figure
5. The combination of the isolation resistor and the load
capacitor forms a pole to increase stability by adding more
phase margin to the overall system. The desired performance depends on the value of the isolation resistor; the
bigger the isolation resistor, the more damped the pulse
response becomes. For LM7171, a 50Ω isolation resistor is
recommended for initial evaluation. Figure 6 shows the
LM7171 driving a 150 pF load with the 50Ω isolation resistor.
01238512
01238517
FIGURE 3. Properly Terminated Signal
01238518
FIGURE 4. Improperly Terminated Signal
FIGURE 5. Isolation Resistor Used
to Drive Capacitive Load
01238513
FIGURE 6. The LM7171 Driving a 150 pF Load
with a 50Ω Isolation Resistor
POWER DISSIPATION
The maximum power allowed to dissipate in a device is
defined as:
=(T
P
D
J(MAX)
−TA)/θ
JA
Where
PD is the power dissipation in a device
T
is the maximum junction temperature
J(max)
is the ambient temperature
T
A
is the thermal resistance of a particular package
θ
JA
For example, for the LM7171 in a SO-8 package, the maximum power dissipation at 25˚C ambient temperature is
730 mW.
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Application Notes (Continued)
Thermal resistance, θ
LM7171
die size, package size and package material. The smaller
the die size and package, the higher θ
DIP package has a lower thermal resistance (108˚C/W) than
that of 8-pin SO (172˚C/W). Therefore, for higher dissipation
capability, use an 8-pin DIP package.
The total power dissipated in a device can be calculated as:
PQis the quiescent power dissipated in a device with no load
connected at the output. P
device with a load connected at the output; it is not the power
dissipated by the load.
Furthermore,
: = supply current x total supply voltage with no load
P
Q
P
: = output current x (voltage difference between sup-
L
ply voltage and output voltage of the same side of
supply voltage)
For example, the total power dissipated by the LM7171 with
=±15V and output voltage of 10V into 1 kΩ is
V
S
P
=PQ+P
D
= (6.5 mA) x (30V) + (10 mA) x (15V − 10V)
=195mW+50mW
= 245 mW
, depends on parameters such as
JA
becomes. The 8-pin
JA
P
D=PQ+PL
is the power dissipated in the
L
L
Multivibrator
01238515
01238581
Pulse Width Modulator
Application Circuit
Fast Instrumentation Amplifier
01238516
Video Line Driver
01238514
01238521
01238580
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Physical Dimensions inches (millimeters) unless otherwise noted
LM7171
8-Pin SOIC
NS Package Number M08A
8-Pin MDIP
NS Package Number N08E
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Notes
National does not assume any responsibility for use of any circuitry described, no circuit patent licenses are implied and National reserves
the right at any time without notice to change said circuitry and specifications.
For the most current product information visit us at www.national.com.
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WITHOUT THE EXPRESS WRITTEN APPROVAL OF THE PRESIDENT AND GENERAL COUNSEL OF NATIONAL SEMICONDUCTOR
CORPORATION. As used herein:
1. Life support devices or systems are devices or systems
LM7171 Very High Speed, High Output Current, Voltage Feedback Amplifier
which, (a) are intended for surgical implant into the body, or
(b) support or sustain life, and whose failure to perform when
properly used in accordance with instructions for use
2. A critical component is 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.
provided in the labeling, can be reasonably expected to result
in a significant injury to the user.
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