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AIC1555
Low-Noise Synchronous PWM Step-Down DC/DC Converter
FEATURES
95% Efficiency or up 700mA Guaranteed Output Current. Adjustable Output Voltage from 0.75V to VIN of a range from +2.5V to 6.5V. Very Low Quiescent Current: 35A (Typ.). Fixed- 500KHz or Adjustable Frequency Synchronous PWM Operation. Synchronizable external Switching Frequency up to 1MHz. Constant Over-current-protection mode. Accurate Reference: 0.75V (2.5%). 100% Duty Cycle in Dropout. Low Profile 8-Pin MSOP Package.
DESCRIPTION
The AIC1555 is a low-noise pulse-widthmodulated (PWM) DC-DC step-down converter. It powers logic circuits in PDAs and small wireless systems such as cellular phones, handy-terminals. The device features an internal synchronous rectifier for high conversion efficiency. Excellent noise characteristics provide and fixed-frequency The operation easy post-filtering.
AIC1555 is ideally suited for Li-ion battery applications. It is also suitable for +3V or +5V fixed input applications. The device can operate in either one of the following four modes. (1) Forced PWM mode operates at a fixed frequency regardless of the load. (2) Synchronizable PWM mode allows the synchronization switching harmonics. (3) PWM/PFM Mode extends battery life by switching to a PFM pulse-skipping mode under light loads. (4) Shutdown mode sets device to standby, reducing supply current to 0.1A or under. The AIC1555 can deliver over 700mA output current. The output voltage can be adjusted from 0.75V to VIN ranging from +2.5V to +6.5V. Other features of the AIC1555 include low quiescent current, low dropout voltage, and a 0.75V reference of 2.5% accuracy. It is available package. in a space-saving 8-pin MSOP by using with an a external minimum frequency
APPLICATIONS
PDAs. Digital Still Cameras. Handy-Terminals. Cellular Phones. CPU I/O Supplies. Cordless Phones. Notebook Chipset Supplies. Battery-Operated Devices (4 NiMH/ NiCd or 1 Li-ion Cells).
Analog Integrations Corporation
Si-Soft Research Center 3A1, No.1, Li-Hsin Rd. I , Science Park , Hsinchu 300, Taiwan , R.O.C. TEL: 886-3-5772500 FAX: 886-3-5772510 www.analog.com.tw
DS-1555G-01 121608
1
AIC1555
TYPICAL APPLICATION CIRCUIT
VIN= 2.5V to 6.5V 1 8 * L1 6.8H D1 SS12 Optional VOUT = 1.8V
VIN
LX
BP CIN 22F
CBP 0.1F
2 BP 3 SHDN 4 FB
GND 7 SYNC/ 6
MODE
CF R1 820K 12pF
RT
5
AIC1555
CO R2 560K 22F
CIN: TAIYO YUDEN LMK316F226ZL-T Ceramic capacitor CO: TAIYO YUDEN LMK316F226ZL-T Ceramic capacitor L1: TDK SLF6025-6R8M1R3 D1: GS SS12 * Note: Efficiency can boost 2% to 4% if D1 is connected.
ORDERING INFORMATION
AIC1555XXXXX PACKING TYPE TR: TAPE & REEL TB: TUBE PACKAGING TYPE O8:MSOP8 P: Lead Free G: Green Package Example: AIC1555PO8TR In MSOP Lead Free Package & Taping & Reel Packing Type PIN CONFIGURATION
TOP VIEW VIN 1 BP 2 SHDN 3 FB 4 8 LX 7 GND 6 SYNC/MODE 5 RT
2
AIC1555
ABSOLUTE MAXIMUM RATINGS
VIN, BP, SHDN, SYNC/MODE, RT to GND BP to VIN LX to GND FB to GND Operating Temperature Range Thermal Resistance Junction to Case Thermal Resistance Junction to Ambient (Assume no ambient airflow, no heatsink) Junction Temperatrue Storage Temperature Range Lead Temperature (Soldering. 10 sec) 125C -65C ~ 150C 260C MSOP8 MSOP8 -0.3 to +7V .-0.3 to 0.3V -0.3 ~ (VIN+0.3V) -0.3 ~ (VBP+0.3V) -40C ~ 85C 75C/W 180C/W
Absolute Maximum Ratings are those values beyond which the life of a device may be Impaired.
TEST CIRCUIT
Refer to Typical Application Circuit.
3
AIC1555
ELECTRICAL CHARACTERISTICS
(VIN=+3.6V, TA=+25C, SYNC/MODE =GND, SHDN =IN, unless otherwise specified.) (Note1)
PARAMETER Input Voltage Range Output Adjustment Range Feedback Voltage Feedback Accuracy Line Regulation Load Regulation Duty Cycle = 100% to 23% IOUT = 0 to 700mA IFB VFB = 1.4V, VIN = 3.6V VIN = 2.5V VIN = 3.6V VIN = 2.5V 1 -50 SYMBOL CONDITIONS VIN VOUT VFB MIN 2.5 VREF 0.731 -2.5 +1 -1.3 0.75 TYP MAX 6.5 VIN 0.769 +2.5 UNITS V V V % % %
FB Input Current
0.01 0.32 0.38 0.32 0.38 1.5 35 0.1
50 0.65 0.65
nA
P-Channel On-Resistance PRDS(ON) ILX = 100mA N-Channel On-Resistance NRDS(ON) ILX = 100mA P-Channel Current-Limit Threshold Quiescent Current Shutdown Supply Current LX Leakage Current Oscillator Frequency SYNC Capture Range Maximum Duty Cycle Undervoltage Lockout Threshold Logic Input High Logic Input Low Logic Input Current SYNC/MODE Minimum Pulse Width dutyMAX UVLO VIH VIL fOSC (Note 2)
A A A A KHz KHz %
2.1 70 1 20 600 1000
SYNC/MODE = GND, VFB = 1.4V, LX unconnected
SHDN = LX = GND, includes LX
leakage current VIN = 5.5V, VLX = 0 or 5.5V -20 400 500 100 VIN rising, typical hysteresis is 85mV 1.9 2
0.1 500
2.0
2.1
V V
SHDN , SYNC/MODE, LIM SHDN , SYNC/MODE, LIM SHDN , SYNC/MODE, LIM
High or low
0.4 -1 500 0.1 1
V A nS
Note 1: Specifications are production tested at TA=25C. Specifications over the -40C to 85C operating temperature range are assured by design, characterization and correlation with Statistical Quality Controls (SQC). Note 2: Maximum specification is guaranteed by design, not production tested.
4
AIC1555
TYPICAL PERFORMANCE CHARACTERISTICS
(TA=25oC, VIN=3.6V, SYNC/MODE=GND, with Schottky diode D1, unless otherwise noted.)
100
100 90
VIN=2.1V
90
VIN=2.1V
Efficiency (%)
Efficiency (%)
80
80
70
70
VIN=5.0V
60
VIN=6.5V
VIN=5.0V
60
VIN=6.5V
VIN=2.3V
50
VIN=3.3V VOUT=1.5V
1000
40 0.1 1 10 100 1000
50
VOUT=1.2V
0.1 1 10 100
40
Load Current (mA)
Load Current (mA) Fig. 1 Load Current vs. Efficiency (VOUT=1.2V) (Refer to typical application circuit)
100
100
Fig. 2 Load Current vs. Efficiency (VOUT=1.5V) (Refer to typical application circuit) (Refer to typical application circuit)
VIN=3.3V
VIN=2.1V
90
90
Efficiency (%)
80
Efficiency (%)
VIN=3.3V
80
70
70
VIN=6.5V VIN=5.0V
VIN=6.5V VIN=5.0V
60
60
50
50
VOUT=1.8V
40 0.1 1 10
VOUT=2.5V
100 1000
40 0.1 1 10 100 1000
Load Current (mA) Fig. 3 Load Current vs. Efficiency (VOUT=1.8V) (Refer to typical application circuit)
100
Fig. 4
Load Current (mA) Load Current vs. Efficiency (VOUT=2.5V) (Refer to typical application circuit)
100
VIN=3.6V
90 90
VIN=3.6V
Efficiency (%)
Efficiency (%)
80
80
VIN=6.5V
70
70
VIN=4.2V
VIN=5.0V
60
60
50
VOUT=3.0V
1 10 100 1000
50
VIN=4.2V
VOUT=3.3V
40 0.1
40
0.1
1
10
100
1000
Fig. 5
Load Current (mA) Load Current vs. Efficiency (VOUT=3.0V) (Refer to typical application circuit)
Load Current (mA) Fig. 6 Load Current vs. Efficiency (VOUT=3.3V) (Refer to typical application circuit)
5
AIC1555
TYPICAL PERFORMANCE CHARACTERISTICS (continued)
100 W/ Schottky Diode 90 80 Efficiency (%) W/o Schottky Diode 70 60 50 40 30 0.1 VOUT=3.0V 1 10 Load Current (mA) 100 1000 SYNC= VIN SYNC= GND
0.765 0.760
VIN=3.6V
Reference Voltage (V)
0.755 0.750 0.745 0.740 0.735 0.730 0.725 -50
-25
0
25
50
75
100
125
Fig. 7
Load Current vs. Efficiency (W/ or W/O Schottky Diode)
Temperature (C) Fig. 8 Reference Voltage vs. Temperature
550 540 530
550
VIN=3.6V
540 530
Frequency (KHz)
520 510 500 490 480 470 460 450 -40 -20 0 20 40 60 80 100 120
Frequency (KHz)
520 510 500 490 480 470 460 450 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0
Temperature (C) Fig. 9 Oscillator Frequency vs. Temperature
Supply Voltage (V) Fig. 10 Frequency vs. Input Voltage
0.44 0.42
1.82
RDSON (m)
0.38 0.36 0.34 0.32 0.30 0.28 0.26 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0
Output Voltage (V)
0.40
Main Switch
1.80
VIN=3.6V
1.78
1.76
Synchronous Switch
1.74
1.72 1 10 100 1000
Supply Voltage (V) Fig. 11 RDSON vs. Supply Voltage
Load Current (mA) Fig. 12 Output Voltage vs. Load Current
6
AIC1555
TYPICAL PERFORMANCE CHARACTERISTICS (continued)
300
100
VOUT=1.8V
250
90 80
PWM/PFM
DC Supply Current ( A)
SYNC/PWM=IN
150
Efficiency (%)
200
70 60 50 40
PWM
100
SYNC/PWM=GND
50
30 20
VIN=3.6V VOUT=1.8V
0
2.5
3.0
3.5
4.0
4.5
5.0
5.5
6.0
6.5
7.0
10 0.1 1 10 100 1000
Supply Voltage (V) Fig. 13 DC Supply Current vs. Supply Voltage Fig. 14
Load current (mA) Efficiency vs. Load current
1000
Operation Frequency (KHz)
900
800
700
600
500 2250 2000 1750 1500 1250 1000 750 Tuning Resistor RT (k)
500
250
Fig. 15
Operation Frequency vs. Tuning Resistor
Fig. 16
Over Current Protection
VOUT=1.8V; ILOAD=50mA to 500mA; SYNC/MODE=IN
VOUT=1.8V; ILOAD=50mA to 500mA; SYNC/MODE=GND
Fig. 17 Load Transient Response
Fig. 18
Load Transient Response
7
AIC1555
TYPICAL PERFORMANCE CHARACTERISTICS (continued)
VIN=3.3V to 5V, SYNC/MODE=IN
IOUT=1.8V;
ILOAD=200mA to 500mA;
Fig. 19 Line Transient Response
Fig. 20
Start-up from Shutdown, RLOAD=3
VIN=3.6V, VOUT=1.8V, ILOAD=800mA VOUT
VIN=3.6V; VOUT=1.8V; ILOAD=500mA SYNC/MODE=IN
VLX
Fig. 21 Switching Waveform
Fig. 22 Output Ripple voltage
8
AIC1555
BLOCK DIAGRAM
BP Chip S upply 0.75V RE F S HDN C urrent A M P . V IN + X5 5 Q1 x1 + PW M Com parator + Therm al P rotection Control Lo gic A ntiS hootThrough Q3 PW M/P FM Control REF + PFM C om pa rator Zero C ross Com parator LX RE F Q2 X20 V IN 10
S lope RT 500K H z O scillator Frequenc y S YNC S election Current Lim it Com parator
Com pen sation
P hase Com pensation FB FB REF + E rro r A MP .
+ G ND
PIN DESCRIPTIONS
PIN 1: VINSupply Voltage Input ranging from +2.5V to +6.5V. Bypass with a 22F capacitor. Supply Bypass Pin internally connecting to VIN. Bypass with a 0.1F capacitor. PIN 6: SYNC/MODEOscillator Sync and Low-Noise, Mode-Control Input. SYNC/MODE = VIN (Forced PWM Mode) SYNC/MODE = GND (PWM/PFM Mode) An external clock signal connecting to this pin allows LX switching synchronization. PIN 7: GNDGround. PIN 8: LXInductor connecting to the Drains of the Internal Power MOSFETs
PIN 2: BP-
PIN 3: SHDN - Active-Low, Shutdown-Control Input reducing supply current to 0.1A in shutdown mode. PIN 4: FBFeedback Input. PIN 5: RTFrequency Adjustable Pin connecting to GND through a resistor to increase frequency. (Refer to Fig. 15)
9
AIC1555
APPLICATION INFORMATIONS
block. Similarly, when Q3 is on, Q2 will turn off.
Introduction
AIC1555 is a low-noise, pulse-width-modulated (PWM), DC-DC step-down converter. It features an internal synchronous rectifier, which eliminates external Schottky diode. AIC1555 is suitable for Lilon battery applications, or can be used at 3V or 5V fixed input voltage. It operates in one of following four modes. (1) Forced PWM mode operates at a fixed frequency regardless of the load. (2) Synchronizable PWM mode allows the synchronization switching harmonics. (3) PWM/PFM Mode extends battery life by switching to a PFM pulse-skipping mode under light loads. (4) Shutdown mode sets device to standby, reducing supply current to 0.1A or under. Continuous output current of AIC1555 can be upward to 700mA and output voltage can be adjusted from 0.75V to VIN with an input range from 2.5V to 6.5V by a voltage divider. AIC1555 also features high efficiency, low dropout voltage, and a 0.75V reference with 2.5% accuracy. It is available in a space-saving 8-pin MSOP package. by using with an a external minimum AIC1555 provides current limit function by using a 5 resistor. When Q1 turns on, current follows through the 5 resistor. And current amplifier senses the voltage, which crosses the resistor, and amplifies it. When the sensed voltage gets bigger than reference voltage, output current will be clamped a maximum level. AIC1555 provides the thermal protection. When the action is happened then the control logic shuts the device off.
PWM/PFM Function
When connecting SYNC/MODE pin to VIN, the device is forced mode of into with PWM (Pulse-Widthfrequency. is easily Modulated) Advantage constant frequency
frequency
constant
reducing noise without complex post-filter. But its disadvantage is low efficiency at light loading. Therefore, AIC1555 provides a function to solve this problem. When connecting SYNC/MODE pin to GND, device is able to get into PWM/PFM (Pulse-Frequency-Modulated) modes. Under a light loading condition, the device turns to PFM mode, which results in a higher efficiency. PWM mode is on when heavy loading applies and the noise is reduced.
Operation
When power on, control logic block detects SYNC/MODE pin connecting to VIN or GND to determine operation function and gives a signal to PWM/PFM control block to determine the proper comparator (ref. Block Diagram). AIC1555 works increase efficiency. When control logic block turns Q2 on, Q3 will turn off through anti-short-through
Frequency Synchronization
Connecting an external clock signal to SNYC/MODE pin can control switching frequency. The acceptable range is from 500kHz to 1MHz. This mode exhibits low output ripple as well as low audio noise and reduces RF interference while providing reasonable low current efficiency.
with an internal synchronous rectifier
Q3, to
10
AIC1555
100% Duty Cycle Operation When the input voltage approaches the output voltage, the converter continuously turns Q2 on. In this mode, the output voltage is equal to the input voltage minus the voltage, which is the drop across Q2. If input voltage is very close to output voltage, the switching mode goes from pure PWM mode to 100% duty cycle operation. During this transient state mentioned above, large output ripple voltage will appear on output terminal. Output Capacitor The selection of output capacitor depends on the suitable ripple voltage. Lower ripple voltage corresponds to lower ESR (Equivalent Series Resistor) of output capacitor. Typically, once the ESR is satisfied with the ripple voltage, the value of capacitor is adequate for filtering. The formula of ripple voltage is as below: 1 VOUT = IL ESR + 8 fC OUT
V V OUT = OUT (2) 2 x Ma 2 x 0.27 Note that output voltage can be defined according L1 >
to user's requirement to get a suitable inductor value.
Components Selection
Inductor The inductor selection depends on the operating frequency of AIC1555. The internal switching frequency is 500KHz, and the external synchronized frequency ranges from 500KHz to 1MHz. A higher frequency allows the uses of smaller inductor and capacitor values. But, higher frequency results lower efficiency due to the internal switching loss. The ripple current IL interrelates with the inductor value. A lower inductor value gets a higher ripple current. Besides, a higher VIN or VOUT can also get the same result. The inductor value can be calculated as the following formula. V 1 1 - OUT L= V (f )(IL ) OUT VIN suitable inductor value. Since AIC1555 can be used in ceramic capacitor application, the component selection will be different from the one for the application above. AIC1555 has a built-in slope compensation, which acitvates when duty cycle is larger than 0.45. The slope Ma, 0.27V/s, has to be larger than half of M2. M2 is equal to output voltage divided by L1. The formula of inductor is shown as below:
(3)
Besides, in buck converter architecture frequency stands at 1/(LC) when a double pole formed by the inductor and output capcitor occurs. This will reduce phase margin of circuit so that the stability gets weakened. Therefore, a feedforward capacitor that is parallel with R1 can be added to reduce output ripple voltage and increase circuit stability. The output capacitor can be calculated as the following formula.
1 L1 x C O
1 R1 x CF
(4)
(1) For more reduction in the ripple voltage, a 12pF ceramic capacitor, which is parallel with output capacitor, is used. External Schottky Diode AIC1555 has an internal synchronous rectifier, instead of Schottky diode in buck converter. However, a blank time, which is an interval when both of main switch, Q2, and synchronous rectifier, Q3, are off; occurs at each switching cycle. At the moment, AIC1555 has a decreasing efficiency. Therefore, an external Schottky diode is needed to reinforce the efficiency.
Users can define the acceptable IL to gain a
11
AIC1555
Since the diode conducts during the off time, the peak current and voltage of converter is not allowed to exceed the diode ratings. The ratings of diode can be calculated by the following formulas:
close as possible to each other to reduce the input ripple voltage. 2. The output loop, which is consisted of inductor, Schottky diode and output capacitor, should be kept as small as possible. 3. The routes with large current should be kept short and wide. 4. Logically the large current on the converter,
VD,MAX( OFF ) = VIN
(5)
ID,MAX(ON) = IOUT,MAX +
IL 2
(6)
ID,AVG( ON)
= IOUT - IIN = IOUT - D x IOUT = (1 - D) x IOUT
(7)
when AIC1555 is on or off, should flow at the same direction. 5. The FB pin should connect to feedback resistors directly. And the route should be away from the noise source, such as inductor of LX line. 6. Grounding all components at the same point (8) may effectively reduce the occurrence of loop. A stability ground plane is very important for gaining higher efficiency. When a ground plane is cut apart, it may cause disturbed signal and noise. If possible, two or three through-holes can ensure the stability of grounding.
Adjustable Output Voltage
AIC1555 appears a 0.75V reference voltage at FB pin. Output voltage, ranging from 0.75V to VIN, can be set by connecting two external resistors, R1 and R2. VOUT can be calculated as: R1 VOUT = 0.75 V x (1 + ) R2
Applying a 12pF capacitor parallel with R1 can prevent stray pickup. They should sit as close to AIC1555 as possible. But load transient response is degraded by this capacitor.
Over Current Protection
The current limiter circuit monitors the current flowing through the P-channel MOS connected to the Lx pin, and features a constant-current type current limit mode. If the inductor current does not exceed the current limit, the high-side MOSFET turns on normally. When the driver current is greater than a specific level, the constant-current type current limit function operates to turn off the pulses from the Lx pin at any switching cycle. This features a constant-current type over current protection
Example
Here are two examples to prove the components selector guide above.
1. Tantalum capacitors application:
Assume AIC1555 is used for mobile phone application, which uses 1-cell Li-ion battery with 2.7V to 4.2V input voltage for power source. The required load current is 700mA, and the output voltage is 1.8V. Substituting VOUT=1.8V, VIN=4.2V,
I=250mA, and f=500KHz to equation (1)
L=
1.8 V 1.8 V 1 - = 8.23H 500KHz x 250mA 4.2V
Layout Consideration
To ensure a proper operation of AIC1555, the following points should be given attention to: 1. Input capacitor and Vin should be placed as
Therefore, 10H is proper for the inductor. And the inductor of series number SLF6025-100M1R0 from TDK with 57.3m series resistor is recommended for the best efficiency.
12
AIC1555
For output capacitor, the ESR is more important than its capacity. Assuming ripple voltage Of the same AIC1555 application above, except for ceramic capacitor used, Co, R1, and R2 can be calculated as following formulas. And the same values of load current and output voltage at 700mA and 1.8V respectively are used. VOUT is substituted by 1.8V in equation (2) as
V=100mV, then the ESR can be calculated as: V 100mV ESR= = = 0.4 I 250mA
Therefore, a 33F/10V capacitor, MCM series from NIPPON, is recommend. Schottky selection is calculated as following. VD,MAX( OFF ) = VIN = 4.2V
L1 >
V OUT = 1.8 = 3.33 H 0.54 0.54
ID,MAX(ON) = IOUT,MAX +
IL 2 250mA = 800mA + 2
Let L1 = 6.8H, and choose CF = 12pF, R1 = 820k. Co calculated by the following formula can improve circuit stability.
= 925mA
1
ID,avg(ON) = (1 - D ) x IOUT
1 .8 = (1 - ) x 800mA 4 .2 = 457.14mA
According the datas above, the Schottky diode, SS12, from GS is recommend. For feedback resistors, choose R2=390k and R1 can be calculated as follow:
O
1 R1 x CF
L1 x C
Therefore,
C
O
=
(R1 x CF )2 = (820k x 12pF)2
L1 6.8.
= 12 F
Say, CO is 22F. Then, R2 can be decided by equation (8) as
1.8V R1 = - 1 x 390k = 546k ; use 560k 0.75
Fig. 22 and Fig.23 shows the application circuit of AIC1555.
R1 R2
=
VOUT 1.8 -1= - 1 = 1.4 V 0.75 ref
So, R2 = 560k. Note: Schottky diode, SS12 from GS, is still required in this application.
2. Ceramic capacitors application:
13
AIC1555
VIN= 2.5V to 6.5V
1
VIN
LX
8 **
L1 10H D1 SS12
VOUT = 1.8V
BP + CIN 10F
CBP 0.1F
2 BP 3 SHDN 4 FB
GND 7
SYNC/ 6 MODE
CF R1 560K 10P + *CO1 R2 390K 33F *CO2 4.7F
RT
5
Optional
AIC1555
* Note: CO1 can be omitted if CO2 is 10F Ceramic CIN: NIPPON 10F/10V Tantalum capacitor CO1: NIPPON 33F/6V Tantalum capacitor L: TDK SLF6025-100M1R0 D1: GS SS12 ** Note: Efficiency can boost 2% to 4% if D1 is connected.
Fig. 23 AIC1555 Application Circuit (Tantalum capacitor application)
VIN= 2.5V to 6.5V
1
VIN
LX
8 *
L1 6.8H D1 SS12 Optional
VOUT = 1.8V
BP CIN 22F
CBP 0.1F
2 BP 3 SHDN 4 FB
GND 7 SYNC/ 6
MODE
CF R1 820K 12pF
RT
5
AIC1555
CO R2 560K 22F
CIN: TAIYO YUDEN LMK316F226ZL-T Ceramic capacitor CO: TAIYO YUDEN LMK316F226ZL-T Ceramic capacitor L1: TDK SLF6025-6R8M1R3 D1: GS SS12 * Note: Efficiency can boost 2% to 4% if D1 is connected.
Fig. 24 AIC1555 Application Circuit (Ceramic capacitor application)
14
AIC1555
PHYSICAL DIMENSIONS
MSOP 8 (unit: mm)
D
Note:
Information provided by AIC is believed to be accurate and reliable. However, we cannot assume responsibility for use of any circuitry other than circuitry entirely embodied in an AIC product; nor for any infringement of patents or other rights of third parties that may result from its use. We reserve the right to change the circuitry and specifications without notice. Life Support Policy: AIC does not authorize any AIC product for use in life support devices and/or systems. Life support devices or systems are devices or systems which, (I) are intended for surgical implant into the body or (ii) 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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