AOSMD AOZ1915

AOZ1915
1.5A General Purpose Boost Regulator
General Description
Features
The AOZ1915 is a high-performance, current-mode,
constant frequency boost regulator with internal
MOSFET and internal Schottky diode. The 600kHz /
1.2MHz switching frequency allows the use of low-profile
inductor and capacitors. The current-mode control
ensures easy loop compensation and fast transient
response. The AOZ1915 works from a 2.7V to 5.5V input
voltage range and generates an output voltage as high
as 22V. Other features include input under-voltage
lockout, cycle-by-cycle current limit, thermal shutdown
and soft-start.
●
2.7V to 5.5V input voltage range
●
Adjustable output up to 22V
●
Internal Schottky diode
●
600kHz/1.2MHz constant switching frequency
●
Cycle-by-cycle current limit
●
Thermal overload protection
●
Programmable Soft-start
●
Small 4mm x 3mm DFN 12L package
The AOZ1915 is available in a tiny 4mm x 3mm 12-pin
DFN package and is rated over a -40°C to +85°C
Applications
●
LCD TV
●
LCD Monitors
●
Notebook Displays
●
PCMCIA Cards
●
Hand-Held Devices
●
GPS power
●
TV tuner
Typical Application Circuit
L1
4.7µH
VIN
VOUT
LX OUT
C1
10µF
R2
IN
FSEL
FB
AOZ1915
C2
10µF
R1
SS
C4
OFF
ON
GND
COMP
EN
R3
C3
Figure 1. Typical Application Circuit
Rev. 1.1 July 2009
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Page 1 of 14
AOZ1915
Ordering Information
Part Number
Operating Temperature Range
Package
Environmental
AOZ1915DI
-40°C to +85°C
4x3 DFN-12
Green Product
AOS Green Products use reduced levels of Halogens, and are also RoHS compliant.
Please visit www.aosmd.com/web/quality/rohs_compliant.jsp for additional information.
Pin Configuration
LX
1
12
OUT
LX
2
11
GND
LX
3
10
GND
IN
4
9
EN
FSEL
5
8
FB
SS
6
7
COMP
OUT
GND
DFN-12
(Top View)
Pin Description
Pin Number
Pin Name
Pin Description
1, 2, 3
LX
Boost Regulator Switching Node.
4
IN
Input Supply Pin.
5
FSEL
Frequency Select Pin. The switching frequency is 1.2MHz when FSEL is connected to IN,
and 600kHz when FSEL is connected to ground.
6
SS
7
COMP
8
FB
Feedback Input. Connect a resistive divider between the boost regulator output and
ground with the center tap connected to FB to set output voltage.
9
EN
Enable Input. Pull EN high to enable the boost regulator and pull EN low to disable the regulator.
10, 11
GND
Ground.
12
OUT
Boost Regulator Output
Rev. 1.1 July 2009
Soft-Start Pin. Connect a capacitor from SS to GND to set the soft-start period.
Compensation Pin. Connect a RC network between COMP and ground to compensate the
control loop.
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AOZ1915
Absolute Maximum Ratings
Recommend Operating Ratings
Exceeding the Absolute Maximum ratings may damage the device.
The device is not guaranteed to operate beyond the Maximum
Operating Ratings.
Parameter
Rating
IN to GND
Parameter
-0.3V to +6V
LX, OUT to GND
-0.3V to +26V
COMP, EN, FB, FSEL, SS to GND
Storage Temperature (TS)
Supply Voltage (VIN)
-0.3V to +6V
2.7V to 5.5V
Output Voltage (VOUT)
-65°C to +150°C
ESD Rating(1)
Rating
VIN to 22V
Ambient Temperature (TA)
2kV
-40°C to +85°C
Package Thermal Resistance
4 x 3 DFN-10 (ΘJA)
Note:
48°C/W
1. Devices are inherently ESD sensitive, handling precautions are
required. Human body model rating: 1.5kΩ in series with 100pF.
Functional Block Diagram
4.7µH
VOUT
VIN
LX
10F
10µF
R
Bias
Generator
IN
OUT
Q
S
EN
ILIM
UVLO
Comp
OSC
UVLO
Threshold
Thermal
Shutdown
PWM
Comp
Error
Amp
VFB
Gm
REF
FSEL
OFF
ON
EN
SS
Soft-Start
COMP
GND
Rev. 1.1 July 2009
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Page 3 of 14
AOZ1915
Electrical Characteristics
TA = 25°C, VIN = 3.3V, unless otherwise specified. Specifications in BOLD indicate an ambient temperature range of -40°C to +85°C.
Symbol
VIN
VIN_UVLO
Parameter
Conditions
IN Supply Voltage Range
IN UVLO Threshold
Min.
2.7
IN rising
IN UVLO Hysteresis
IIN_ON
IN Quiescent Current
EN = IN, FB = 1.4V
IN Shutdowns Current
EN = GND
ISS
Max.
Units
5.5
V
2.6
V
200
IIN_OFF
VFB
Typ.
FB Voltage
1.143
1.17
mV
1.2
mA
1
μA
1.197
V
1
μA
FB Input Bias Current
VIN = 2.7V
FB Line Regulation
2.7V < VIN < 5.5V
0.15
%/V
FB Load Regulation
Varies load so the input DC current
changes from 0.2A to 1.8A,
VOUT =16V
1.5
%
Soft-Start Charge Current
7
10
μA
13
ERROR AMPLIFIER
gm
Error Amplifier Transconductance
200
μA / V
AV
Error Amplifier Voltage Gain
340
V/V
OSCILLATOR
fSW
(1)
DMAX
Switching Frequency
Maximum Duty Cycle
FSEL = IN
960
1200
1440
FSEL = GND
480
600
720
FSEL = IN, FB = 0V
87
FSEL = GND, FB = 0V
90
kHz
%
POWER SWITCH
RON_LX
LX On Resistance
0.20
0.25
Ω
LX Leakage Current
LX = 22V, EN = GND
2
μA
Diode Leakage
OUT = 22V, LX = 0V
10
μA
Diode forward voltage
Id = 100mA
DIODE
Ileak
0.3
V
PROTECTIONS
ILIM
Current Limit
1.5
2.2
2.9
A
Thermal Shutdown Threshold
145
°C
Thermal Shutdown Hysteresis
35
°C
TSD
LOGIC INPUTS
EN Logic High Threshold
1.5
V
EN Logic Low Threshold
FSEL High
0.9Vin
FSEL Low
0.1Vin
EN, FSEL Input Current
0.4
V
0.1
μA
Notes:
1. Guaranteed by design.
Rev. 1.1 July 2009
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Page 4 of 14
AOZ1915
Typical Performance Characteristics
Circuit of Figure 1. TA = 25°C, VIN = 3.3V, VEN = 2V, VOUT = 8V unless otherwise specified.
Switching Waveform
Switching Waveform
(IOUT = 400mA, fLX = 1.2MHz, L = 4.7µH)
(IOUT = 400mA, fLX = 600kHz, L = 10µH)
LVX
5V/div
LVX
5V/div
IL
0.5A/div
IL
0.5A/div
400ns/div
1µs/div
Load Transient Response
(IOUT = 40mA to 400mA, fLX = 1.2MHz, L = 4.7µH)
Load Transient Response
(IOUT = 40mA to 400mA, fLX = 600kHz, L = 10µH)
Vo Ripple
200mV/div
Vo Ripple
200mV/div
Io
0.2A/div
Io
0.2A/div
200µs/div
200µs/div
Startup Waveform
Startup Waveform
(ROUT = 200Ω, fLX = 1.2MHz, L = 4.7µH)
(ROUT = 200Ω, fLX = 600kHz, L = 10µH)
VEN
2V/div
VEN
2V/div
Vo
5V/div
Vo
5V/div
IL
0.5A/div
IL
0.5A/div
200µs/div
Rev. 1.1 July 2009
200µs/div
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Page 5 of 14
AOZ1915
Efficiency
AOZ1915 Efficiency
(VIN = 5V, VOUT = 12V)
100
95
Efficiency (%)
90
85
80
fSW = 600kHz, L = 10µH
75
fSW = 1MHz, L = 4.7µH
70
65
60
55
50
1
10
100
1,000
Load Current (mA)
AOZ1915 Efficiency
(VIN = 3.3V, VOUT = 12V)
100
95
Efficiency (%)
90
85
80
fSW = 600kHz, L = 10µH
75
fSW = 1MHz, L = 4.7µH
70
65
60
55
50
1
10
100
1,000
Load Current (mA)
Rev. 1.1 July 2009
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Page 6 of 14
AOZ1915
Detailed Description
The AOZ1915 is a current-mode step up regulator
(Boost Converter) with integrated NMOS switch. It
operates from a 2.7V to 5.5V input voltage range and
supplies up to 22V output voltage. The duty cycle can be
adjusted to obtain a wide range of output voltage up to
22V. Features include enable control, cycle by cycle
current limit, input under voltage lockout, adjustable
soft-start and thermal shut down.
The AOZ1915 is available in DFN 4x3 package
Enable and Soft Start
The AOZ1915 has the adjustable soft start feature to limit
in-rush current and ensure the output voltage ramps up
smoothly to regulation voltage. A soft start process
begins when the input voltage rises to 2.7V and voltage
on EN pin is HIGH. In soft start process, a 10µA internal
current source charges the external capacitor at SS.
As the SS capacitor is charged, the voltage at SS rises.
The SS voltage clamps the reference voltage of the error
amplifier, therefore output voltage rising time follows the
SS pin voltage. With the slow ramping up output voltage,
the inrush current can be prevented.
The EN pin of the AOZ1915 is active high. Connect the
EN pin to VIN if enable function is not used. Pull it to
ground will disable the AOZ1915. Do not leave it open.
The voltage on EN pin must be above 1.5 V to enable the
AOZ1915. When voltage on EN pin falls below 0.4V, the
AOZ1915 is disabled. If an application circuit requires the
AOZ1915 to be disabled, an open drain or open collector
circuit should be used to interface to EN pin.
Steady-State Operation
Under steady-state conditions, the converter operates in
fixed frequency.
The AOZ1915 integrates an internal N-MOSFET as the
control switch. Inductor current is sensed by amplifying
the voltage drop across the drain to source of the control
power MOSFET. Output voltage is divided down by the
external voltage divider at the FB pin. The difference of
the FB pin voltage and reference is amplified by the
internal transconductance error amplifier. The error
voltage, which shows on the COMP pin, is compared
against the current signal, which is sum of inductor
current signal and ramp compensation signal, at PWM
comparator input. If the current signal is less than the
error voltage, the internal NMOS switch is on. The
inductor current ramps up. When the current signal
exceeds the error voltage, the switch is off. The inductor
current is freewheeling through the internal Schottky
diode to output.
Rev. 1.1 July 2009
Switching Frequency
The AOZ1915 switching frequency is fixed and set by an
internal oscillator and FSEL. When the voltage of FSEL
is high (connected to Vin) The switching frequency is
1.2MHz; when the voltage of FSEL is low (connected to
GND), the switching frequency is 600 KHz.
Output Voltage Programming
Output voltage can be set by feeding back the output to
the FB pin with a resistor divider network. In the
application circuit shown in Figure 1. The resistor divider
network includes R1 and R2. Usually, a design is started
by picking a fixed R1 value and calculating the required
R2 with equation below:
R 2⎞
⎛
V O = 1.2 × ⎜ 1 + -------⎟
R 1⎠
⎝
Some standard value of R1, R2 for most commonly used
output voltage values are listed in Table 1.
Table 1.
VO (V)
R2 (kΩ)
R1 (kΩ)
8
170
30
12
270
30
16
370
30
18
420
30
25
595
30
The combination of R1 and R2 should be large enough to
avoid drawing excessive current from the output, which
will cause power loss.
Protection Features
The AOZ1915 has multiple protection features to prevent
system circuit damage under abnormal conditions.
Over Current Protection (OCP)
The sensed inductor current signal is also used for over
current protection. Since the AOZ1915 employs peak
current mode control, the COMP pin voltage is
proportional to the peak inductor current. The peak
inductor current is automatically limited cycle by cycle.
When the current of control NMOS reaches the current
limit threshold, the cycle by cycle current limit circuit turns
off the NMOS immediately to terminate the current duty
cycle. The inductor current stop rising. The cycle by cycle
current limit protection directly limits inductor peak
current. The average inductor current is also limited due
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AOZ1915
to the limitation on peak inductor current. When cycle by
cycle current limit circuit is triggered, the output voltage
drops as the duty cycle decreasing.
Power-On Reset (POR)
A power-on reset circuit monitors the input voltage. When
the input voltage exceeds 2.7V, the converter starts
operation. When input voltage falls below 2.2V, the
converter will stop switching.
Thermal Protection
An internal temperature sensor monitors the junction
temperature. It shuts down the internal control circuit and
NMOS switch if the junction temperature exceeds 145°C.
Application Information
The basic AOZ1915 application circuit is shown in
Figure 1. Component selection is explained below.
Input Capacitor
The input capacitor (C1 in Figure 1) must be connected to
the VIN pin and GND pin of the AOZ1915 to maintain
steady input voltage. The voltage rating of input capacitor
must be greater than maximum input voltage + ripple
voltage. The RMS current rating should be greater than
the the inductor ripple current:
V IN⎞
V IN ⎛
ΔI L = ----------- × ⎜ 1 – ---------⎟
f×L ⎝
VO ⎠
The input capacitor value should be greater than 4.7µF
for normal operation. The capacitor can be electrolytic,
tantalum or ceramic. The input capacitor should be place
as close as possible to the IC; if not possible, please put
0.1µF decoupling ceramics capacitor between IN pin and
GND nearby.
Inductor
The inductor is used to supply higher output voltage
when the NMOS switch is off. For given input and output
voltage, inductance and switching frequency together
decide the inductor ripple current, which is:
V IN⎞
V IN ⎛
ΔI L = ----------- × ⎜ 1 – ---------⎟
f×L ⎝
VO ⎠
The peak inductor current is:
ΔI L
I Lpeak = I IN + -------2
Rev. 1.1 July 2009
High inductance gives low inductor ripple current but
requires larger size inductor to avoid saturation. Low
ripple current reduces inductor core losses. It also
reduces RMS current through inductor, switch and
freewheeling diode, which results in less conduction loss.
Usually, peak to peak ripple current on inductor is
designed to be 30% to 50% of input current.
When selecting the inductor, make sure it is able to
handle the peak current without saturation even at the
highest operating temperature.
The inductor takes the highest current in a boost circuit.
The conduction loss on inductor needs to be checked for
thermal and efficiency requirements.
Surface mount inductors in different shape and styles are
available from Coilcraft, Elytone and Murata. Shielded
inductors are small and radiate less EMI noise. But they
cost more than unshielded inductors. The choice
depends on EMI requirement, price and size.
Output Capacitor
The output capacitor is selected based on the DC output
voltage rating, output ripple voltage specification and
ripple current rating.
The selected output capacitor must have a higher rated
voltage specification than the maximum desired output
voltage including ripple. De-rating needs to be
considered for long term reliability.
Output ripple voltage specification is another important
factor for selecting the output capacitor. In a boost converter circuit, output ripple voltage is determined by load
current, input voltage, output voltage, switching frequency, output capacitor value and ESR. It can be calculated by the equation below::
V IN ⎞ ⎞
⎛
⎛
⎜
⎜ 1 – ---------------⎟ ⎟
V OUT⎠ ⎟
⎜ VO
⎝
-⎟
ΔV O = I LOAD × ⎜ --------- × ESR CO + ----------------------------f × CO ⎟
⎜ V IN
⎜
⎟
⎝
⎠
where;
ILOAD is the load current,
CO is the output capacitor value, and
ESRCO is the Equivalent Series Resistor of output capacitor.
When low ESR ceramic capacitor is used as output
capacitor, the impedance of the capacitor at the
switching frequency dominates. Output ripple is mainly
caused by capacitor value and load current with the fixed
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Page 8 of 14
AOZ1915
frequency, input and output voltage. The output ripple
voltage calculation can be simplified to:
V IN ⎞
⎛
⎜ 1 – ---------------⎟
V OUT⎠
⎝
ΔV O = I L × ----------------------------f × CO
and phase. Several different types of compensation
network can be used for AOZ1915. For most cases, a
series capacitor and resistor network connected to the
COMP pin sets the pole-zero and is adequate for a stable
high-bandwidth control loop.
In the AOZ1915, FB pin and COMP pin are the inverting
input and the output of internal transconductance error
amplifier. A series R and C compensation network
connected to COMP provides one pole and one zero.
The pole is:
Output capacitor with the range of 4.7µF to 22µF ceramic
capacitor usually can meet most applications.
Loop Compensation
The AOZ1915 employs peak current mode control for
easy use and fast transient response. Peak current mode
control eliminates the double pole effect of the output
L&C filter. It greatly simplifies the compensation loop
design.
With peak current mode control, the boost power stage
can be simplified to be a one-pole, one left plane zero
and one right half plane (RHP) system in frequency
domain. The pole is dominant pole and can be
calculated by:
1
f P1 = ----------------------------------2π × C O × R L
G EA
f P2 = ------------------------------------------2π × C C × G VEA
where;
GEA is the error amplifier transconductance, which is 200 x 10-6
A/V,
GVEA is the error amplifier voltage gain, which is 340 V/V, and
CC is compensation capacitor.
The zero given by the external compensation network,
capacitor CC (C3 in Figure 1) and resistor RC
(R3 in
Figure 1), is located at:
1
f Z2 = ----------------------------------2π × C C × R C
Choosing the suitable CC and RC by trading-off stability
and bandwidth.
The zero is a ESR zero due to output capacitor and its
ESR. It is can be calculated by:
1
f Z1 = -----------------------------------------------2π × C O × ESR CO
Thermal Management and Layout
Consideration
ESRCO is the equivalent series resistance of output capacitor.
In the AOZ1915 boost regulator circuit, high pulsing
current flows through two circuit loops. The first loop
starts from the input capacitors, to the filter inductor, to
the LX pin, to the internal NMOS switch, to the ground
and back to the input capacitor, when the switch turns on.
The second loop starts from input capacitor, to the filter
inductor, to the LX pin to the internal diode, to the ground
and back to the input capacitor, when the switch is off.
The RHP zero has the effect of a zero in the gain causing
an imposed +20dB/decade on the roll off, but has the
effect of a pole in the phase, subtracting 90° in the
phase. The RHP zero can be calculated by
In PCB layout, minimizing the two loops area reduces the
noise of this circuit and improves efficiency. A ground
plane is recommended to connect input capacitor, output
capacitor, and GND pin of the AOZ1915.
The RHP zero obviously can cause the instable issue if
the bandwidth is higher. It is recommended to design
the bandwidth to lower than the one half frequency of
RHP zero.
In the AOZ1915 boost regulator circuit, the three major
power dissipating components are the AOZ1915 and
output inductor. The total power dissipation of converter
circuit can be measured by input power minus output
power.
where;
CO is the output filter capacitor,
RL is load resistor value, and
The compensation design is actually to shape the
converter close loop transfer function to get desired gain
Rev. 1.1 July 2009
P total_loss = V IN × I IN – V O × I O
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Page 9 of 14
AOZ1915
Several layout tips are listed below for the best electric
and thermal performance.
The power dissipation of inductor can be approximately
calculated by input current and DCR of inductor.
P inductor_loss = I
IN
2
× R inductor × 1.1
1. Do not use thermal relief connection to the VIN and
the GND pin. Pour a maximized copper area to the
GND pin and the VIN pin to help thermal dissipation.
The actual AOZ1915 junction temperature can be
calculated with power dissipation in the AOZ1915 and
thermal impedance from junction to ambient.
2. A ground plane is preferred.
3. Make the current trace from LX pins to L to Co to the
T junction = ( P total_loss – P inductor_loss – P diode_loss ) ×
GND as short as possible.
× Θ + T ambient
4. Pour copper plane on all unused board area and
The maximum junction temperature of AOZ1915 is
145°C, which limits the maximum load current capability.
The thermal performance of the AOZ1915 is strongly
affected by the PCB layout. Extra care should be taken
by users during design process to ensure that the IC will
operate under the recommended environmental
conditions.
connect it to stable DC nodes, like VIN, GND or
VOUT.
5. Keep sensitive signal trace such as trace connected
with FB pin and COMP pin far away from the LX pin.
6. The output schottky diode is integrated into
AOZ1915. Proper layout should incorporate thermal
via connection from top to bottom layers.
COUT
LX
LX
CIN
LX
1
12
OUT
AOZ1915
IN
OUT
GND
GND
R2
EN
GND
C4
FSEL
FB
SS
R1
COMP
4X3 DFN-12
R3
C3
Figure 3 . AOZ1915 PCB Layout Example
Rev. 1.1 July 2009
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Page 10 of 14
AOZ1915
Package Dimensions, DFN 4 x 3
A
D/2
Index Area
(D/2 x E/2)
E/2
E
TOP VIEW
A3
A
Seating
Plane
A1
b
SIDE VIEW
Pin #1 IDA
Chamfer 0.15
e
L1
1
L
L3
E1/2
E1
L3
D1
L2
D2
BOTTOM VIEW
Rev. 1.1 July 2009
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Page 11 of 14
AOZ1915
Package Dimensions, DFN 4 x 3 (Continued)
RECOMMENDED LAND PATTERN
0.50
0.25
0.23
0.50
0.30
1.35
1.60
0.80
0.715
2.70
0.30
0.20 x 45°
0.315
2.065
1.035
Dimensions in millimeters
Symbols
A
A1
A3
b
D
D1
D2
E
E1
e
L
L1
L2
Min.
0.80
0.00
Nom.
0.90
0.02
0.20 REF.
0.20
0.23
4.00 BSC
0.83
0.985
1.86
2.015
Max.
1.00
0.05
0.35
1.09
2.12
Dimensions in inches
Symbols
A
A1
A3
b
D
D1
D2
3.00 BSC
1.60
1.70
0.50 BSC
0.30
0.40
0.50
0.61
0.715
0.82
E
E1
e
L
L1
0.21
L2
1.45
0.315
0.42
Unit: mm
Min.
Nom. Max.
0.031 0.035 0.039
0.000 0.001 0.002
0.008 REF.
0.008 0.009 0.014
0.157 BSC
0.033 0.039 0.043
0.073 0.079 0.083
0.118 BSC
0.063 0.067
0.020 BSC
0.012 0.016 0.020
0.024 0.028 0.032
0.057
0.008
0.012
0.017
L3
aaa
bbb
0.30 REF.
0.15
0.10
L3
aaa
bbb
0.012 REF.
0.006
0.004
ccc
ddd
0.10
0.08
ccc
ddd
0.004
0.003
Notes:
1. Controlling dimension is millimeter, converted inch dimensions are not necessarily exact.
2. The location of the terminal #1 identifier and terminal numbering conforms to JEDEC publication 95 SPP-002.
3. Dimension b applied to metallized terminal and is measured between 0.20mm and 0.35mm from the terminal tip. If the terminal
has the optional radius on the other end of the terminal, dimension b should not be measured in that radius area.
4. Coplanarity ddd applies to the terminals and all other bottom surface metallization.
Rev. 1.1 July 2009
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Page 12 of 14
AOZ1915
Tape and Reel Dimensions, DFN 4 x 3
Carrier Tape
P1
P2
D1
T
E1
E2
E
C
L
B0
K0
D0
P0
A0
Feeding Direction
UNIT: mm
Package
DFN 4 x 3
(12 mm)
A0
3.40
±0.10
B0
4.40
±0.10
K0
1.10
±0.10
D0
1.50
Min.
D1
1.50
+0.10/-0.0
E
E1
1.75
±0.10
12.0
±0.3
Reel
E2
5.50
±0.05
P0
8.00
±0.10
P1
4.00
±0.10
P2
2.00
±0.10
T
0.30
±0.05
W1
S
G
N
M
K
V
R
H
W
UNIT: mm
Tape Size Reel Size
12mm
ø330
M
N
ø330.0
±2.0
ø79.0
±1.0
W
W1
12.4
17.0
+2.0/-0 +2.6/-0
H
K
S
G
R
V
ø13.0
±0.5
10.5
±0.2
2.0
±0.5
—
—
—
Leader / Trailer & Orientation
Trailer Tape
300mm Min.
75 Empty Pockets
Rev. 1.1 July 2009
Components Tape
Orientation in Pocket
www.aosmd.com
Leader Tape
500mm Min.
125 Empty Pockets
Page 13 of 14
AOZ1915
Package Marking
AOZ1915DI
(4 x 3 DFN-12)
Z1915DI
Part Number Code
FAYWLT
Assembly Lot Code
Fab & Assembly Location
Year & Week Code
Alpha & Omega Semiconductor reserves the right to make changes at any time without notice.
LIFE SUPPORT POLICY
ALPHA & OMEGA SEMICONDUCTOR PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL
COMPONENTS IN LIFE SUPPORT DEVICES OR SYSTEMS.
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.
Rev. 1.1 July 2009
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.
www.aosmd.com
Page 14 of 14