ETC LM258

LM158/LM258/LM358/LM2904
Low Power Dual Operational Amplifiers
General Description
Advantages
The LM158 series consists of two independent, high gain,
internally frequency compensated operational amplifiers
which were designed specifically to operate from a single
power supply over a wide range of voltages. Operation from
split power supplies is also possible and the low power
supply current drain is independent of the magnitude of the
power supply voltage.
Application areas include transducer amplifiers, dc gain
blocks and all the conventional op amp circuits which now
can be more easily implemented in single power supply
systems. For example, the LM158 series can be directly
operated off of the standard +5V power supply voltage which
is used in digital systems and will easily provide the required
interface electronics without requiring the additional ± 15V
power supplies.
The LM358 and LM2904 are available in a chip sized package (8-Bump micro SMD) using National’s micro SMD package technology.
n Two internally compensated op amps
n Eliminates need for dual supplies
n Allows direct sensing near GND and VOUT also goes to
GND
n Compatible with all forms of logic
n Power drain suitable for battery operation
n Pin-out same as LM1558/LM1458 dual op amp
Unique Characteristics
n In the linear mode the input common-mode voltage
range includes ground and the output voltage can also
swing to ground, even though operated from only a
single power supply voltage.
n The unity gain cross frequency is temperature
compensated.
n The input bias current is also temperature compensated.
Features
n Available in 8-Bump micro SMD chip sized package,
(See AN-1112)
n Internally frequency compensated for unity gain
n Large dc voltage gain: 100 dB
n Wide bandwidth (unity gain): 1 MHz
(temperature compensated)
n Wide power supply range:
— Single supply: 3V to 32V
— or dual supplies: ± 1.5V to ± 16V
n Very low supply current drain (500 µA) — essentially
independent of supply voltage
n Low input offset voltage: 2 mV
n Input common-mode voltage range includes ground
n Differential input voltage range equal to the power
supply voltage
n Large output voltage swing: 0V to V+− 1.5V
Voltage Controlled Oscillator (VCO)
00778723
© 2002 National Semiconductor Corporation
DS007787
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LM158/LM258/LM358/LM2904 Low Power Dual Operational Amplifiers
March 2002
LM158/LM258/LM358/LM2904
Absolute Maximum Ratings
Distributors for availability and specifications.
(Note 9)
If Military/Aerospace specified devices are required,
please contact the National Semiconductor Sales Office/
LM158/LM258/LM358
LM2904
LM158A/LM258A/LM358A
Supply Voltage, V+
32V
Differential Input Voltage
32V
26V
−0.3V to +32V
−0.3V to +26V
Molded DIP
830 mW
830 mW
Metal Can
550 mW
Small Outline Package (M)
530 mW
micro SMD
435mW
Input Voltage
26V
Power Dissipation (Note 1)
530 mW
Output Short-Circuit to GND
(One Amplifier) (Note 2)
V+ ≤ 15V and TA = 25˚C
Continuous
Continuous
50 mA
50 mA
0˚C to +70˚C
−40˚C to +85˚C
Input Current (VIN < −0.3V) (Note 3)
Operating Temperature Range
LM358
LM258
−25˚C to +85˚C
LM158
−55˚C to +125˚C
Storage Temperature Range
−65˚C to +150˚C
−65˚C to +150˚C
260˚C
260˚C
300˚C
300˚C
260˚C
260˚C
Lead Temperature, DIP
(Soldering, 10 seconds)
Lead Temperature, Metal Can
(Soldering, 10 seconds)
Soldering Information
Dual-In-Line Package
Soldering (10 seconds)
Small Outline Package
Vapor Phase (60 seconds)
215˚C
215˚C
Infrared (15 seconds)
220˚C
220˚C
See AN-450 “Surface Mounting Methods and Their Effect on Product Reliability” for other methods of soldering
surface mount devices.
ESD Tolerance (Note 10)
250V
250V
Electrical Characteristics
V+ = +5.0V, unless otherwise stated
Parameter
Conditions
LM158A
Min Typ
LM358A
Max
Min Typ
LM158/LM258
Max
Min Typ
Units
Max
Input Offset Voltage
(Note 5), TA = 25˚C
1
2
2
3
2
5
mV
Input Bias Current
IIN(+) or IIN(−), TA = 25˚C,
20
50
45
100
45
150
nA
VCM = 0V, (Note 6)
Input Offset Current
IIN(+) − IIN(−), VCM = 0V, TA = 25˚C
Input Common-Mode
V+ = 30V, (Note 7)
Voltage Range
(LM2904, V+ = 26V), TA = 25˚C
Supply Current
Over Full Temperature Range
2
10
V+−1.5
0
5
30
V+−1.5
0
3
0
30
nA
V+−1.5
V
RL = ∞ on All Op Amps
V+ = 30V (LM2904 V+ = 26V)
V+ = 5V
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2
1
2
1
2
1
2
mA
0.5
1.2
0.5
1.2
0.5
1.2
mA
V+ = +5.0V, unless otherwise stated
Parameter
Conditions
LM358
Min
Typ
LM2904
Max
Min
Units
Typ
Max
Input Offset Voltage
(Note 5) , TA = 25˚C
2
7
2
7
mV
Input Bias Current
IIN(+) or IIN(−), TA = 25˚C,
45
250
45
250
nA
50
5
50
nA
VCM = 0V, (Note 6)
Input Offset Current
IIN(+) − IIN(−), VCM = 0V, TA = 25˚C
5
+
Input Common-Mode
V = 30V, (Note 7)
Voltage Range
(LM2904, V+ = 26V), TA = 25˚C
Supply Current
Over Full Temperature Range
+
0
V −1.5
+
0
V −1.5
V
RL = ∞ on All Op Amps
V+ = 30V (LM2904 V+ = 26V)
V+ = 5V
1
2
1
2
mA
0.5
1.2
0.5
1.2
mA
Electrical Characteristics
V+ = +5.0V, (Note 4), unless otherwise stated
Parameter
Conditions
Large Signal Voltage
V+ = 15V, TA = 25˚C,
Gain
RL ≥ 2 kΩ, (For VO = 1V
LM158A
Min Typ
LM358A
Max
Min Typ
LM158/LM258
Max
Min Typ
Units
Max
50
100
25
100
50
100
V/mV
70
85
65
85
70
85
dB
65
100
65
100
65
100
dB
−120
dB
to 11V)
Common-Mode
TA = 25˚C,
Rejection Ratio
VCM = 0V to V+−1.5V
Power Supply
V+ = 5V to 30V
Rejection Ratio
(LM2904, V+ = 5V
to 26V), TA = 25˚C
Amplifier-to-Amplifier
f = 1 kHz to 20 kHz, TA = 25˚C
Coupling
(Input Referred), (Note 8)
Output Current
−120
−120
Source VIN+ = 1V,
VIN− = 0V,
V+ = 15V,
20
40
20
40
20
40
mA
10
20
10
20
10
20
mA
12
50
12
50
12
50
µA
VO = 2V, TA = 25˚C
Sink VIN− = 1V, VIN+ = 0V
V+ = 15V, TA = 25˚C,
VO = 2V
VIN− = 1V,
VIN+ = 0V
TA = 25˚C, VO = 200 mV,
V+ = 15V
Short Circuit to Ground
TA = 25˚C, (Note 2),
40
V+ = 15V
Input Offset Voltage
(Note 5)
Input Offset Voltage
RS = 0Ω
IIN(+) − IIN(−)
Input Offset Current
RS = 0Ω
7
IIN(+) or IIN(−)
60
40
5
15
7
30
Drift
Input Bias Current
40
4
Drift
Input Offset Current
60
20
60
mA
7
mV
7
75
µV/˚C
100
10
200
10
300
10
40
100
40
200
40
nA
pA/˚C
300
nA
V+−2
V
+
Input Common-Mode
V = 30 V, (Note 7)
Voltage Range
(LM2904, V+ = 26V)
0
3
V+−2
0
V+−2
0
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LM158/LM258/LM358/LM2904
Electrical Characteristics
LM158/LM258/LM358/LM2904
Electrical Characteristics
(Continued)
V+ = +5.0V, (Note 4), unless otherwise stated
Parameter
Conditions
Large Signal Voltage
V+ = +15V
Gain
(VO = 1V to 11V)
LM158A
Min Typ
LM358A
Max
Min Typ
25
LM158/LM258
Max
15
Min Typ
Units
Max
25
V/mV
RL ≥ 2 kΩ
VOH V+ = +30V
Output
(LM2904, V+ = 26V)
Voltage
RL = 2 kΩ
26
RL = 10 kΩ
27
VOL V+ = 5V, RL = 10 kΩ
Swing
Output Current
Source VIN+ = +1V, VIN− = 0V,
V+ = 15V, VO = 2V
Sink VIN− = +1V, VIN+ = 0V,
V+ = 15V, VO = 2V
26
28
5
27
26
28
20
5
V
27
28
20
5
V
20
mV
10
20
10
20
10
20
mA
10
15
5
8
5
8
mA
Electrical Characteristics
V+ = +5.0V, (Note 4), unless otherwise stated
Parameter
LM358
Conditions
Large Signal Voltage
V+ = 15V, TA = 25˚C,
Gain
RL ≥ 2 kΩ, (For VO = 1V
Min
Typ
25
LM2904
Max
Units
Min
Typ
Max
100
25
100
V/mV
65
85
50
70
dB
65
100
50
100
dB
−120
dB
to 11V)
Common-Mode
TA = 25˚C,
Rejection Ratio
VCM = 0V to V+−1.5V
Power Supply
V+ = 5V to 30V
Rejection Ratio
(LM2904, V+ = 5V
to 26V), TA = 25˚C
Amplifier-to-Amplifier
f = 1 kHz to 20 kHz, TA = 25˚C
Coupling
(Input Referred), (Note 8)
Output Current
−120
Source VIN+ = 1V,
VIN− = 0V,
V+ = 15V,
20
40
20
40
mA
10
20
10
20
mA
12
50
12
50
µA
VO = 2V, TA = 25˚C
Sink VIN− = 1V, VIN+ = 0V
V+ = 15V, TA = 25˚C,
VO = 2V
VIN− = 1V,
VIN+ = 0V
TA = 25˚C, VO = 200 mV,
V+ = 15V
Short Circuit to Ground
TA = 25˚C, (Note 2),
40
V+ = 15V
Input Offset Voltage
(Note 5)
Input Offset Voltage
RS = 0Ω
IIN(+) − IIN(−)
Input Offset Current
RS = 0Ω
7
IIN(+) or IIN(−)
Input Common-Mode
V+ = 30 V, (Note 7)
Voltage Range
(LM2904, V+ = 26V)
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45
10
40
0
4
60
mA
10
mV
7
150
Drift
Input Bias Current
40
9
Drift
Input Offset Current
60
µV/˚C
200
10
500
V+−2
40
0
nA
pA/˚C
500
nA
V+ −2
V
(Continued)
V+ = +5.0V, (Note 4), unless otherwise stated
Parameter
LM358
Conditions
Large Signal Voltage
V+ = +15V
Gain
(VO = 1V to 11V)
Min
Typ
LM2904
Max
15
Min
Typ
Units
Max
15
V/mV
RL ≥ 2 kΩ
Output
Voltage
Swing
Output Current
VOH V+ = +30V
(LM2904, V+ = 26V)
RL = 2 kΩ
26
RL = 10 kΩ
27
VOL V+ = 5V, RL = 10 kΩ
22
28
5
Source VIN+ = +1V, VIN− = 0V,
V+ = 15V, VO = 2V
Sink VIN− = +1V, VIN+ = 0V,
V+ = 15V, VO = 2V
23
20
V
24
5
V
100
mV
10
20
10
20
mA
5
8
5
8
mA
Note 1: For operating at high temperatures, the LM358/LM358A, LM2904 must be derated based on a +125˚C maximum junction temperature and a thermal
resistance of 120˚C/W for MDIP, 182˚C/W for Metal Can, 189˚C/W for Small Outline package, and 230˚C/W for micro SMD, which applies for the device soldered
in a printed circuit board, operating in a still air ambient. The LM258/LM258A and LM158/LM158A can be derated based on a +150˚C maximum junction temperature.
The dissipation is the total of both amplifiers — use external resistors, where possible, to allow the amplifier to saturate or to reduce the power which is dissipated
in the integrated circuit.
Note 2: Short circuits from the output to V+ can cause excessive heating and eventual destruction. When considering short cirucits to ground, the maximum output
current is approximately 40 mA independent of the magnitude of V+. At values of supply voltage in excess of +15V, continuous short-circuits can exceed the power
dissipation ratings and cause eventual destruction. Destructive dissipation can result from simultaneous shorts on all amplifiers.
Note 3: This input current will only exist when the voltage at any of the input leads is driven negative. It is due to the collector-base junction of the input PNP
transistors becoming forward biased and thereby acting as input diode clamps. In addition to this diode action, there is also lateral NPN parasitic transistor action
on the IC chip. This transistor action can cause the output voltages of the op amps to go to the V+voltage level (or to ground for a large overdrive) for the time duration
that an input is driven negative. This is not destructive and normal output states will re-establish when the input voltage, which was negative, again returns to a value
greater than −0.3V (at 25˚C).
Note 4: These specifications are limited to −55˚C ≤ TA ≤ +125˚C for the LM158/LM158A. With the LM258/LM258A, all temperature specifications are limited to
−25˚C ≤ TA ≤ +85˚C, the LM358/LM358A temperature specifications are limited to 0˚C ≤ TA ≤ +70˚C, and the LM2904 specifications are limited to −40˚C ≤ TA ≤
+85˚C.
Note 5: VO . 1.4V, RS = 0Ω with V+ from 5V to 30V; and over the full input common-mode range (0V to V+ −1.5V) at 25˚C. For LM2904, V+ from 5V to 26V.
Note 6: The direction of the input current is out of the IC due to the PNP input stage. This current is essentially constant, independent of the state of the output so
no loading change exists on the input lines.
Note 7: The input common-mode voltage of either input signal voltage should not be allowed to go negative by more than 0.3V (at 25˚C). The upper end of the
common-mode voltage range is V+ −1.5V (at 25˚C), but either or both inputs can go to +32V without damage (+26V for LM2904), independent of the magnitude of
V+.
Note 8: Due to proximity of external components, insure that coupling is not originating via stray capacitance between these external parts. This typically can be
detected as this type of capacitance increases at higher frequencies.
Note 9: Refer to RETS158AX for LM158A military specifications and to RETS158X for LM158 military specifications.
Note 10: Human body model, 1.5 kΩ in series with 100 pF.
5
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LM158/LM258/LM358/LM2904
Electrical Characteristics
LM158/LM258/LM358/LM2904
Typical Performance Characteristics
Input Voltage Range
Input Current
00778734
00778735
Supply Current
Voltage Gain
00778736
00778737
Open Loop Frequency Response
Common-Mode Rejection Ratio
00778738
00778739
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6
(Continued)
Voltage Follower Pulse Response
Voltage Follower Pulse Response (Small Signal)
00778741
00778740
Large Signal Frequency Response
Output Characteristics Current Sourcing
00778742
00778743
Output Characteristics Current Sinking
Current Limiting
00778744
00778745
7
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LM158/LM258/LM358/LM2904
Typical Performance Characteristics
LM158/LM258/LM358/LM2904
Typical Performance Characteristics
(Continued)
Input Current (LM2902 only)
Voltage Gain (LM2902 only)
00778746
00778747
Application Hints
Capacitive loads which are applied directly to the output of
the amplifier reduce the loop stability margin. Values of 50
pF can be accomodated using the worst-case non-inverting
unity gain connection. Large closed loop gains or resistive
isolation should be used if larger load capacitance must be
driven by the amplifier.
The bias network of the LM158 establishes a drain current
which is independent of the magnitude of the power supply
voltage over the range of 3 VDC to 30 VDC.
Output short circuits either to ground or to the positive power
supply should be of short time duration. Units can be destroyed, not as a result of the short circuit current causing
metal fusing, but rather due to the large increase in IC chip
dissipation which will cause eventual failure due to excessive function temperatures. Putting direct short-circuits on
more than one amplifier at a time will increase the total IC
power dissipation to destructive levels, if not properly protected with external dissipation limiting resistors in series
with the output leads of the amplifiers. The larger value of
output source current which is available at 25˚C provides a
larger output current capability at elevated temperatures
(see typical performance characteristics) than a standard IC
op amp.
The circuits presented in the section on typical applications
emphasize operation on only a single power supply voltage.
If complementary power supplies are available, all of the
standard op amp circuits can be used. In general, introducing a pseudo-ground (a bias voltage reference of V+/2) will
allow operation above and below this value in single power
supply systems. Many application circuits are shown which
take advantage of the wide input common-mode voltage
range which includes ground. In most cases, input biasing is
not required and input voltages which range to ground can
easily be accommodated.
The LM158 series are op amps which operate with only a
single power supply voltage, have true-differential inputs,
and remain in the linear mode with an input common-mode
voltage of 0 VDC. These amplifiers operate over a wide range
of power supply voltage with little change in performance
characteristics. At 25˚C amplifier operation is possible down
to a minimum supply voltage of 2.3 VDC.
Precautions should be taken to insure that the power supply
for the integrated circuit never becomes reversed in polarity
or that the unit is not inadvertently installed backwards in a
test socket as an unlimited current surge through the resulting forward diode within the IC could cause fusing of the
internal conductors and result in a destroyed unit.
Large differential input voltages can be easily accomodated
and, as input differential voltage protection diodes are not
needed, no large input currents result from large differential
input voltages. The differential input voltage may be larger
than V+ without damaging the device. Protection should be
provided to prevent the input voltages from going negative
more than −0.3 VDC (at 25˚C). An input clamp diode with a
resistor to the IC input terminal can be used.
To reduce the power supply current drain, the amplifiers
have a class A output stage for small signal levels which
converts to class B in a large signal mode. This allows the
amplifiers to both source and sink large output currents.
Therefore both NPN and PNP external current boost transistors can be used to extend the power capability of the basic
amplifiers. The output voltage needs to raise approximately
1 diode drop above ground to bias the on-chip vertical PNP
transistor for output current sinking applications.
For ac applications, where the load is capacitively coupled to
the output of the amplifier, a resistor should be used, from
the output of the amplifier to ground to increase the class A
bias current and prevent crossover distortion. Where the
load is directly coupled, as in dc applications, there is no
crossover distortion.
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8
8-Bump micro SMD
LM358 micro SMD Marking Orientation
00778756
00778755
Top View
(Bump Side Down)
Top View
LM2904 micro SMD Marking Orientation
Metal Can Package
00778701
Top View
00778757
Top View
DIP/SO Package
00778702
Top View
9
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LM158/LM258/LM358/LM2904
Connection Diagrams
LM158/LM258/LM358/LM2904
Ordering Information
Package
Temperature Range
−55˚C to 125˚C
−25˚C to 85˚C
SO-8
8-Pin Molded
DIP
8-Pin Ceramic
DIP
TO-5, 8-Pin
Metal Can
LM358AM
LM358AMX
LM358M
LM358MX
LM2904M
LM2904MX
LM358AN
LM358N
LM2904N
LM158AH/883(Note 11)
LM158H/883(Note 11)
LM158AH
LM158H
LM158AHLQML(Note 12)
LM158AHLQMLV(Note 12)
NSC Drawing
M08A
N08E
J08A
LM258H
LM358H
H08C
LM358BP
LM358BPX
LM158AWG/883
LM2904IBP
LM2904IBPX
BPA08AAB
WG10A
Note 11: LM158 is available per SMD #5962-8771001
LM158A is available per SMD #5962-8771002
Note 12: See STD Mil DWG 5962L87710 for Radiation Tolerant Devices
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−40˚C to 85˚C
LM158AJ/883(Note 11)
LM158J/883(Note 11)
LM158J
LM158AJLQML(Note 12)
LM158AJQMLV(Note 12)
8-Bump micro
SMD
14-Pin Ceramic
SOIC
0˚C to 70˚C
10
LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC)
Non-Inverting DC Gain (0V Output)
00778706
00778707
*R not needed due to temperature independent IIN
DC Summing Amplifier
(VIN’S ≥ 0 VDC and VO ≥ 0 VDC)
Power Amplifier
00778709
VO = 0 VDC for VIN = 0 VDC
AV = 10
00778708
Where: VO = V1 + V2 + V3 + V4
(V1 + V2) ≥ (V3 + V4) to keep VO
> 0 VDC
11
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LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
“BI-QUAD” RC Active Bandpass Filter
00778710
fo = 1 kHz
Q = 50
Av = 100 (40 dB)
Fixed Current Sources
Lamp Driver
00778712
00778711
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12
LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
LED Driver
Current Monitor
00778713
00778714
*(Increase R1 for IL small)
VL ≤ V+ −2V
Driving TTL
Voltage Follower
00778715
00778717
VO = VIN
Pulse Generator
00778716
13
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LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
Squarewave Oscillator
Pulse Generator
00778718
00778719
Low Drift Peak Detector
00778720
HIGH ZIN
LOW ZOUT
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14
LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
High Compliance Current Sink
Comparator with Hysteresis
00778722
00778721
IO = 1 amp/volt VIN
(Increase RE for IO small)
Voltage Controlled Oscillator (VCO)
00778723
*WIDE CONTROL VOLTAGE RANGE: 0 VDC ≤ VC ≤ 2 (V+ −1.5V DC)
15
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LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
AC Coupled Inverting Amplifier
00778724
Ground Referencing a Differential Input Signal
00778725
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16
LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
AC Coupled Non-Inverting Amplifier
00778726
Av = 11 (As Shown)
DC Coupled Low-Pass RC Active Filter
00778727
fo = 1 kHz
Q=1
AV = 2
17
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LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
Bandpass Active Filter
00778728
fo = 1 kHz
Q = 25
High Input Z, DC Differential Amplifier
00778729
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18
LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
Photo Voltaic-Cell Amplifier
Bridge Current Amplifier
00778730
00778733
High Input Z Adjustable-Gain
DC Instrumentation Amplifier
00778731
19
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LM158/LM258/LM358/LM2904
Typical Single-Supply Applications
(V+ = 5.0 VDC) (Continued)
Using Symmetrical Amplifiers to
Reduce Input Current (General Concept)
00778732
Schematic Diagram
(Each Amplifier)
00778703
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20
LM158/LM258/LM358/LM2904
Physical Dimensions
inches (millimeters) unless otherwise noted
Metal Can Package (H)
NS Package Number H08C
Cerdip Package (J)
NS Package Number J08A
21
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LM158/LM258/LM358/LM2904
Physical Dimensions
inches (millimeters) unless otherwise noted (Continued)
SOIC Package (M)
NS Package Number M08A
Molded Dip Package (N)
NS Package Number N08E
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22
LM158/LM258/LM358/LM2904
Physical Dimensions
inches (millimeters) unless otherwise noted (Continued)
Order Number LM158AWG/883
NS Package Number WG10A
23
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LM158/LM258/LM358/LM2904 Low Power Dual Operational Amplifiers
Physical Dimensions
inches (millimeters) unless otherwise noted (Continued)
8-Bump micro SMD
NS Package Number BPA08AAB
X1 = 1.285 X2 = 1.285 X3 = 0.850
NOTES: UNLESS OTHERWISE SPECIFIED
1. EPOXY COATING
2. 63Sn/37Pb EUTECTIC BUMP
3. RECOMMEND NON-SOLDER MASK DEFINED LANDING PAD.
4. PIN A1 IS ESTABLISHED BY LOWER LEFT CORNER WITH RESPECT TO TEXT ORIENTATION REMAINING PINS ARE NUMBERED
COUNTERCLOCKWISE.
5. XXX IN DRAWING NUMBER REPRESENTS PACKAGE SIZE VARIATION WHERE X1 IS PACKAGE WIDTH, X2 IS PACKAGE LENGTH AND X3 IS
PACKAGE HEIGHT.
6. REFERENCE JEDEC REGISTRATION MO-211, VARIATION BC.
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into the body, or (b) support or sustain life, and
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 to the user.
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