AOSMD AOZ1606

AOZ1606
500 mA / 3 MHz EZBuck Regulator
General Description
Features
The AOZ1606 is a high-performance, easy-to-use Buck
regulator. The 3 MHz switching frequency, low quiescent
current and small package size make it an ideal choice
for portable applications. The AOZ1606 is optimized for
operation with a tiny 1.0 H inductor and a small 10 F
output capacitor to achieve a small solution size with high
performance.
 2.5 V to 5.5 V input voltage range
The AOZ1606 operates from a 2.5 V to 5.5 V input
voltage range and provides up to 500 mA of output
current with an output voltage adjustable down to 0.6 V.
In shutdown mode, the current consumption is reduced
to less than 0.1 A.
 3 MHz constant frequency operation
The AOZ1606 is available in a tiny 2 mm x 2 mm 8-pin
DFN package and is rated over a -40 °C to +85 °C
ambient temperature range.
 Internal soft-start
 0.05 A shutdown current
 Output voltage adjustable to 0.6 V
 Fixed output voltages available
 ± 1.5% initial accuracy
 Up to 500 mA continuous output current
 Low drop-out operation: 100% duty cycle
 Cycle-by-cycle current-limit
 Thermal overload protection
 Excellent load transient response
 Tiny 2 mm x 2 mm DFN-8 package
Applications
 Smart phones
 Personal media players
 MP3 players
 Digital still cameras
 Wireless modems and LANs
 Portable USB devices
Typical Application
AOZ1606DI
VIN = 2.5V to 5.5V
IN
L1
1.0µH
VOUT = 500mA
LX
C1
10µF
R1
PGND
C2
10µF
FB
R2
Off On
Rev. 1.1 June 2012
EN
AGND
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Page 1 of 14
AOZ1606
Ordering Information
Part Number
Output
Voltage
Temperature Range
Package
Environmental
AOZ1606DI
Adjustable
-40 °C to +85 °C
2 x 2 DFN-8
Green Product
AOS Green Products use reduced levels of Halogens, and are also RoHS compliant.
Please visit www.aosmd.com/media/AOSGreenPolicy.pdf for additional information.
Pin Configuration
PGND
1
8
LX
VIN
2
7
NC
AGND
NC
3
6
EN
AGND
4
5
FB
2mm x 2mm DFN-8 Package
(Top View)
Pin Description
Pin Number
Pin Name
1
PGND
2
VIN
Input Supply Pin
3, 7
NC
No Connect Pin
4
AGND
Analog Ground
5
FB
Feedback Input. Connect an external resistive voltage divider to FB to set the output voltage.
6
EN
Enable Input. The device is enabled when EN is high and disabled when EN is low.
8
LX
Switching Node
Pad
AGND
Analog Ground
Rev. 1.1 June 2012
Pin Function
Power Ground
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Page 2 of 14
AOZ1606
Absolute Maximum Ratings
Recommended Operating Conditions
Exceeding the Absolute Maximum Ratings may damage the
device.
The device is not guaranteed to operate beyond the
Maximum Recommended Operating Conditions.
Parameter
Rating
IN, EN, FB to AGND
Parameter
-0.3 V to +6 V
LX to AGND
Supply Voltage (VIN)
2.5 V to 5.5 V
-0.3 V to VIN + 0.3 V
Ambient Temperature (TA)
-40 °C to +85 °C
-0.3 V to +0.3 V
Junction Temperature (TJ)
Internally Limited
PGND to AGND
Junction Temperature (TJ)
+150 °C
Storage Temperature (TS)
-65 °C to +150 °C
Maximum Soldering Temperature (10s)
ESD Rating
Rating
(1)
Package Thermal Resistance
2 x 2 DFN-6 (JA)
55 °C/W
+300 °C
2 kV
Note:
1. Devices are inherently ESD sensitive, handling precautions are
required. Human body model rating: 1.5k in series with 100pF.
Electrical Characteristics
TA = 25 °C, VIN = 3.6 V, EN = IN, unless otherwise specified. Specifications in BOLD indicate a temperature range of
-40 °C to +85 °C.
Symbol
Parameter
Conditions
Min.
VIN
Input Voltage Range
2.5
VUV
Under-Voltage Lockout
2.11
Under-Voltage Lockout Hysteresis
IIN
Input Supply Current
IFB
2.3
Units
5.5
V
2.49
V
mV
30
55
0.05
0.1
Feedback Reference Voltage
TA = +25 °C, no load
0.588
0.600
0.612
TA = -40 C to +85 °C, no load
0.585
0.600
0.615
Feedback Line Regulation
VIN = 2.5 V to 5.5 V
Feedback Load Regulation
0 to 500 mA load
Feedback Bias Current
-0.001
% / mA
0.1
1.2
VEN = 5.5 V
V
%/V
A
V
Enable Input Low Voltage
Enable Bias current
A
0.3
0.01
Enable Input High Voltage
IEN
Max
100
EN = IN, VFB = 1 V, no load
EN = AGND
VFB
Typ.
0.4
V
0.01
0.1
A
3
3.75
MHz
OSCILLATOR
fSW
Switching Frequency
2.25
DMAX
Maximum Duty Cycle
100
T(ON)MIN
Minimum On-Time
%
60
ns
1.2
A
PROTECTION
ILIM+
Positive Current Limit
0.7
Thermal Shutdown Threshold
+145
°C
Thermal Shutdown Hysteresis
40
°C
OUTPUT STAGE
RDS(ON)P
PFET On Resistance
ILX = 50 mA sourcing
400
m
RDS(ON)N
NFET On Resistance
ILX = 50 mA sinking
250
m
LX Leakage Current
VEN = 0 V, VLX = 0 V or VIN, VIN = 5 V
Efficiency
VIN = 3.6 V, VOUT = 1.8 V, 200 mA load
Rev. 1.1 June 2012
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1
90
A
%
Page 3 of 14
AOZ1606
Output Voltage Selection for AOZ1606
The output voltage of the AOZ1606 ca be programmed
through the resistor network connected from Vout to
Feedback to Analog Ground. The resistor from FB to
Analog Ground should be 100 k to keep the current
drawn through this network below the 6 A quiencent
current level in PFM mode. The output voltage of the
adjustable AOZ1606 parts ranges from 0.6 V to 3.3 V.
The output voltage formula is:
Table 1. Output Voltage Resistor Selection Table for
Various Vout Voltages
Vout
(V)
R1
(k)
R2
(k)
L
(H)
Cin
(F)
Cout
(F)
C5
(pF)
0.6
0
100
1.0
10
10
100
1.1
83
100
1.0
10
10
100
R1
V OUT = V FB  -------- + 1
 R2

1.2
100
100
1.0
10
10
100
1.3
117
100
1.0
10
10
100
where;
1.5
150
100
1.0
10
10
100
1.6
167
100
1.0
10
10
100
1.7
183
100
1.0
10
10
100
1.8
200
100
1.0
10
10
100
1.875
213
100
1.0
10
10
100
2.5
317
100
1.0
10
10
100
2.8
367
100
1.0
10
10
100
3.3
450
100
1.0
10
10
100
VOUT = Output Voltage (V)
VFB = Feedback Voltage (0.6 V typical)
R1 = Feedback Resistor from Vout to FB ()
R2 = Feedback Resistor from FB to AGND ()
A 100 pF bypass capacitor C5 on the evaluation board,
in parallel with the feedback resistor from Vout to FB is
chosen for increased stability throughout the voltage
range.
Rev. 1.1 June 2012
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Page 4 of 14
AOZ1606
Typical Performance Characteristics
Output Voltage vs. Supply Voltage
Output Voltage vs. Temperature
1.812
1.90
Vin = 5.0 V
Vout = 1.8 V
Vout = 1.8 V
1.85
Output Voltage (V)
Output Voltage (V)
1.810
1.808
1.806
1.804
1.802
Iout = 100 mA
1.80
300 mA
500 mA
1.75
Iout = 100 mA, 300 mA, 500 mA
1.800
1.798
3.5
4.0
4.5
5.0
Supply Voltage (V)
5.5
1.70
-25
6.0
-5
75
95
Switching Frequency vs. Temperature
Output Voltage vs. Output Current
3.20
1.812
1.810
15
35
55
Temperature (°C)
Vout = 1.8 V
Vin = 5.0 V
3.15
Vin = 5.0 V
1.808
Frequency (MHz)
Output Voltage (V)
3.10
1.806
1.804
1.802
1.800
Vin = 3.6 V
3.05
Vin = 3.6 V
3.00
2.95
Vin = 4.5 V
2.90
2.85
2.80
1.798
100
200
300
Output Current (mA)
400
500
2.75
-25
Efficiency vs. Output Current
-5
15
35
55
Temperature (°C)
100
95
95
90
90
Efficiency (%)
Efficiency (%)
(Vout = 1.8 V, L = 1.0 µH)
100
85
75
Vin = 3 V
70
Vin = 2.7 V
Vin = 3.6 V
Vin = 4.5 V
Vin = 2.7 V
85
80
Vin = 3.6 V
75
70
65
60
50
95
Efficiency vs. Output Current
(Vout = 1.5 V, L = 1.0 µH)
80
75
Vin = 4.5 V
65
150
250
350
450
550
60
50
Output Current (mA)
Rev. 1.1 June 2012
150
250
350
450
550
Output Current (mA)
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Page 5 of 14
AOZ1606
Typical Performance Characteristics (Continued)
Efficiency vs. Output Current
Efficiency vs. Output Current
(Vout = 2.5 V, L = 1.0 µH)
(Vout = 3.3 V, L = 1.0 µH)
100
100
95
90
90
85
Efficiency (%)
Efficiency (%)
Vin = 3 V
95
Vin = 3.6 V
80
75
Vin = 4.5 V
80
75
70
65
65
150
250
350
450
550
Vin = 4.5 V
85
70
60
50
Vin = 5 V
60
50
Output Current (mA)
150
250
350
450
550
Output Current (mA)
Startup into PWM Mode
Steady State PWM Mode
VOUT = 1.8V (Output Current = 500mA)
VOUT = 1.8V (Output Current = 500mA)
VSW
2V/div
VSW
2V/div
VOUT
1V/div
IL
500mA/div
EN
2V/div
VOUT
20mV/div
100µs/div
Rev. 1.1 June 2012
200ns/div
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Page 6 of 14
AOZ1606
Block Diagram
VIN
C1
3 MHz
Oscillator
ENABLE
UVLO
Thermal
Shutdown
Output
Logic
Control
+
Isense
Amp
–
L1
LX
VOUT
COUT
PGND
+
Ilimit
Comp
–
+
–
FB
+
Error
Amp
–
Master
Logic
PWM
VREF
600mV
R1
R2
+
–
Operation
The AOZ1606 is a high efficiency step down DC-DC buck
converter that operates typically at 3 MHz fixed Pulse
Width Modulation (PWM) at medium to heavy load
currents. The AOZ1606 can deliver a constant voltage
from a single Li-Ion battery with an input voltage rail from
2.5 Volts to 5.5 Volts. Using a voltage mode architecture
with synchronous rectification, the AOZ1606 has the
ability to deliver up 500 mA of continuous current
depending on the input voltage, output voltage, ambient
temperature and inductor chosen.
Additional feature include under voltage lockout,
over current protection, thermal shutdown and soft-start.
Rev. 1.1 June 2012
Inductor Selection
There are two main considerations when choosing an
inductor; the inductor should not saturate, and the
inductor current ripple should be small enough to achieve
the desire output voltage ripple. A 1 H inductor with a
saturation current of at least 1 A is recommended for the
AOZ1606 full load application. For maximum efficiency,
the inductor’s resistance (DCR) should be as low as
possible. For given input and output voltage, inductance
and switching frequency together decide the inductor
ripple current, which is,
VO 
VO 
I L = -----------   1 – ---------
V IN
fL 
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Page 7 of 14
AOZ1606
The relationship between the input capacitor RMS
current and voltage conversion ratio is calculated and
shown in Figure 1 below. It can be seen that when VO is
half of VIN, CIN is under the worst current stress. The
worst current stress on CIN is 0.5 x IO.
The peak inductor current is:
I L
I Lpeak = I O + -------2
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 and
switches, which results in less conduction loss.
Usually, peak to peak ripple current on inductor is
designed to be 20% to 30% of output current.
0.5
0.4
ICIN_RMS(m) 0.3
IO
0.2
When selecting the inductor, make sure it is able to
handle the peak current without saturation even at the
highest operating temperature.
0.1
0
The inductor takes the highest current in a buck circuit.
The conduction loss on inductor need 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.
Input Capacitor
The input capacitor must be connected to the VIN pin and
PGND pin of AOZ1606 to maintain steady input voltage
and filter out the pulsing input current. The voltage rating
of input capacitor must be greater than maximum input
voltage plus ripple voltage. For greater capacitor
performance, the working capacitance voltage should be
twice Vin.
The input ripple voltage can be approximated by
equation below:
Since the input current is discontinuous in a buck
converter, the current stress on the input capacitor is
another concern when selecting the capacitor. For a buck
circuit, the RMS value of input capacitor current can be
calculated by:
if we let m equal the conversion ratio:
VO
-------- = m
V IN
Rev. 1.1 June 2012
0.5
m
1
Figure 3. ICIN vs. Voltage Conversion Ratio
For reliable operation and best performance, the input
capacitors must have current rating higher than ICIN_RMS
at worst operating conditions. Ceramic capacitors are
preferred for input capacitors because of their low ESR
and high current rating. When selecting ceramic
capacitors, X5R or X7R type dielectric ceramic
capacitors should be used for their better temperature
and voltage characteristics. Note that the ripple current
rating from capacitor manufactures are based on certain
amount of life time. Further de-rating may be necessary
in practical design.
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.
VO  VO
IO

V IN = -----------------   1 – ---------  --------V IN V IN
f  C IN 
VO 
VO 
I CIN_RMS = I O  ---------  1 – ---------
V IN 
V IN
0
Output ripple voltage specification is another important
factor for selecting the output capacitor. In a buck
converter circuit, output ripple voltage is determined by
inductor value, switching frequency, output capacitor
value and ESR. It can be calculated by the equation
below:
1
V O = I L   ESR CO + -------------------------

8fC 
O
where,
CO is output capacitor value and
ESRCO is the Equivalent Series Resistor of output
capacitor.
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Page 8 of 14
AOZ1606
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 inductor ripple current. The output
ripple voltage calculation can be simplified to:
1
V O = I L  ------------------------8fC
Soft Start
O
If the impedance of ESR at switching frequency
dominates, the output ripple voltage is mainly decided by
capacitor ESR and inductor ripple current. The output
ripple voltage calculation can be further simplified to:
V O = I L  ESR CO
For lower output ripple voltage across the entire
operating temperature range, X5R or X7R dielectric type
of ceramic, or other low ESR tantalum are recommended
to be used as output capacitors.
In a buck converter, output capacitor current is
continuous. The RMS current of output capacitor is
decided by the peak to peak inductor ripple current. It can
be calculated by:
I L
I CO_RMS = ---------12
Usually, the ripple current rating of the output capacitor
is a smaller issue because of the low current stress.
When the buck inductor is selected to be very small
and inductor ripple current is high, output capacitor could
be overstressed.
Thermal Shutdown
In most applications the AOZ1606 does not dissipate
much heat due to its high efficiency. But in an application
where the AOZ1606 is running at high ambient
temperature with low supply voltage and high duty cycle,
the heat dissipated may exceed the maximum junction
temperature. If the junction temperature reaches
approximately 140 °C (typical), the internal High Side
and Low Side MOSFET switching is disabled until the
temperature on the die has sufficiently fallen below
105°C. The device remains in thermal shutdown until the
junction temperature falls below the thermal shutdown
hysteresis.
Undervoltage Lockout
The undervoltage lockout circuit prevents the device from
malfunctioning at low input voltages and from excessive
Rev. 1.1 June 2012
discharge of the battery by disabling the output stage of
the converter. The AOZ1606 will resume normal
operation when the input supply voltage rises high
enough to properly function. The undervoltage lockout
threshold is typically 2.3 Volts.
The AOZ1606 has a soft-start circuit that limits the
inrush current during startup. Soft start is activated when
EN goes from logic low to logic high after Vin reaches 2.3
Volts.
Over Current Protection (OCP)
The sensed inductor current signal is also used for over
current protection. Since the AOZ1606 employs peak
current mode control, the COMP pin voltage is
proportional to the peak inductor current. The COMP pin
voltage is limited to be between 0.4 V and 2.5 V
internally. The peak inductor current is automatically
limited cycle by cycle.
When the output is shorted to ground under fault
conditions, the inductor current decays very slow during
a switching cycle because of VO = 0 V. To prevent
catastrophic failure, a secondary current limit is designed
inside the AOZ1606. The measured inductor current is
compared against a preset voltage which represents the
current limit, approximately 1 A. When the output current
is more than current limit, the high side switch will be
turned off. The converter will initiate a soft start once the
over-current condition disappears.
Enable
The EN pin of the AOZ1606 is active high. Connect the
EN pin to VIN if enable function is not used. Pull it to
ground will disable the AOZ1606. Do not leave it open.
The voltage on EN pin must be above 2 V to enable
the AOZ1606. When voltage on EN pin falls below 0.6 V,
the AOZ1606 is disabled. If an application circuit requires
the AOZ1606 to be disabled, an open drain or open
collector circuit should be used to interface to EN pin.
100% Duty Cycle Low Drop Out Operation
The AOZ1606 can operate at 100% duty cycle. As the
input voltage comes close to the nominal output voltage
the high side MOSFET is turned on 100% for one or
more cycle. With further decreasing voltage input the
high-side MOSFET switch is turned on completely. The
convertor now offers a low input-to-output voltage
difference. This is useful in battery operated devices to
achieve the longest operation time by taking advantage
of the entire battery voltage range.
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Page 9 of 14
AOZ1606
Thermal Management and Layout Considerations
In the AOZ1606 buck regulator circuit, high pulsing
current flows through two circuit loops. The first loop
starts from the input capacitors, to the VIN pin, to the
LX pin, to the filter inductor, to the output capacitor and
load, and then return to the input capacitor through
ground. Current flows in the first loop when the high side
switch is on. The second loop starts from inductor, to the
output capacitors and load, to the low side NMOSFET.
Current flows in the second loop when the low side
NMOSFET is on.
In PCB layout, minimizing the two loops area reduces the
noise of this circuit and improves efficiency. A ground
plane is strongly recommended to connect input
capacitor, output capacitor, and PGND pin of the
AOZ1606.
In the AOZ1606 buck regulator circuit, the major power
dissipating components are the AOZ1606 and the output
inductor. The total power dissipation of converter circuit
can be measured by input power minus output power.
P total_loss = V IN  I IN – V O  I O
The power dissipation of inductor can be approximately
calculated by output current and DCR of inductor.
P inductor_loss = IO2  R inductor  1.1
The actual junction temperature can be calculated with
power dissipation in the AOZ1606 and thermal
impedance from junction to ambient.
T junction =  P total_loss – P inductor_loss    JA
The maximum junction temperature of AOZ1606 is
140 ºC, which limits the maximum load current capability.
Please see the thermal de-rating curves for maximum
load current of the AOZ1606 under different ambient
temperature.
The thermal performance of the AOZ1606 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.
The AOZ1606 is an exposed pad DFN-8 package.
Several layout tips are listed below for the best electric
and thermal performance.
1. The exposed pad is connected to PGND. Connect a
large copper plane to this pad to help thermal
dissipation.
2. Do not use thermal relief connection from the VIN pin
and the PGND pin. Pour a maximized copper area to
the PGND pin and the VIN pin to help thermal
dissipation.
3. Input capacitor should be connected as close as
possible to the VIN pin and the PGND pin. For optimal performance of the device, place bulk capacitor
and de-coupling capacitor no further than 50 mils
from the device.
4. A ground plane is preferred. If a ground plane is not
used, separate PGND from AGND and connect them
only at one point to avoid the PGND pin noise
coupling to the AGND pin.
5. Make the current trace from LX pin to L to Co to
PGND as short as possible.
6. Pour copper planes on all unused board area and
connect them to stable DC nodes, like VIN, GND
or VOUT.
7. Keep sensitive signal traces away from the LX pin.
Rev. 1.1 June 2012
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Page 10 of 14
AOZ1606
Figure 2. AOZ1606 (DFN-8) PCB Layout
Rev. 1.1 June 2012
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Page 11 of 14
AOZ1606
Package Dimensions, DFN 2x2, 8L
B
D
C A B
bbb
A
8
b
e
8
R
aaa C
2x
E
Pin#1 Identification
Option 1
E1
L
1
D1
1
a a a C 2x
BOTTOM VIEW
TOP VIEW
8
ccc C
A C
C
A1
ddd C
Pin#1 Identification
Option 2
seating
plan
SIDE VIEW
Chamfer 0.2x45°
1
BOTTOM VIEW
RECOMMENDED LAND PATTERN
0.50
Dimensions in millimeters
0.25
0.25
0.85
0.90
1.70
0.30
1.50
UNIT: mm
Symbols
A
A1
b
c
D
D1
E
E1
e
Min.
0.70
0.00
0.18
L
R
aaa
bbb
ccc
ddd
0.20
1.90
1.35
1.90
0.75
Nom.
0.75
0.02
0.25
0.20 REF
2.00
1.50
2.00
0.90
0.50 BSC
Max.
0.80
0.05
0.30
0.30
0.20
0.15
0.10
0.10
0.08
0.40
2.10
1.60
2.10
1.00
Dimensions in inches
Symbols
A
A1
b
c
D
D1
E
E1
e
Min.
0.028
0.000
0.007
Nom. Max.
0.030 0.031
0.001 0.002
0.010 0.012
0.008 REF
0.075 0.079 0.083
0.053 0.059 0.063
0.075 0.079 0.083
0.030 0.035 0.039
0.020 BSC
L
R
aaa
bbb
ccc
ddd
0.008
0.012
0.008
0.006
0.004
0.004
0.003
0.016
Notes:
1. Dimensioning and tolerancing conform to ASME Y14.5M-1994.
2. Controlling dimension is in millimeter, converted inch dimensions are not necessarily exact.
3. Dimension b applies to matellized terminal and is measured between 0.10mm and 0.30mm from the terminal tip.
If the terminal has the optional radius on the other end of the terminal, the 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 June 2012
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Page 12 of 14
AOZ1606
Tape and Reel Dimensions, DFN 2x2, 8L
Carrier Tape
SECTION A--A
FEEDING DIRECTION
UNIT: MM
Package
A0
B0
DFN 2x2
2.25
±0.05
2.25
±0.05
K0
D0
D1
E
E1
E2
P0
P1
P2
1.00 1.50 1.00
8.00 1.75
±0.05 ±0.10 ±0.25 ±0.30 ±0.10
-0.10
3.50 4.00
±0.05 ±0.10
4.00 2.00
±0.10 ±0.05
M
N
W1
W2
H
S
K
Ø177.8
MAX.
53.6
MIN.
8.4
+2.5
-0.0
14.4
MAX.
13.0
+0.5
-0.3
1.5
MIN.
10.1
MIN.
T
0.254
±0.02
Reel
UNIT: MM
Tape Size
8mm
Reel Size
Ø177.8
Leader/Trailer and Orientation
Rev. 1.1 June 2012
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Page 13 of 14
AOZ1606
Part Marking
AOZ1606DI
(2x2 DFN-8)
AH O A
Part Number
Y W LT
Year Code
Assembly Location
Option Code
Assembly Lot
Week Code
This datasheet contains preliminary data; supplementary data may be published at a later date.
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 June 2012
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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Page 14 of 14