PROFET® BTS 6163 D
Data Sheet 1 of 18 Rev. 1.0, 2007-07-23
Smart Highside Power Switch
Reversave
Reverse battery protection by self turn on of
power MOSFET
Features
Short circuit protection with latch
Current limitation
Overload protection
Thermal shutdown with restart
Overvoltage protection (including load dump)
Loss of ground protection
Loss of Vbb protection (with external diode for
charged inductive loads)
Very low standby current
Fast demagnetization of inductive loads
Electrostatic discharge (ESD) protection
Optimized static electromagnetic compatibility
(EMC)
Green Product (RoHS compliant)
AEC qualified
Diagnostic Function
Proportional load current sense (with defined fault signal in case of overload operation, overtemperature
shutdown and/or short circuit shutdown)
Application
Power switch with current sense diagnostic feedback for 42V and 24 V DC grounded loads
All types of resistive, inductive and capacitive loads
Replaces electromechanical relays, fuses and discrete circuits
General Description
N channel vertical power FET with charge pump, current controlled input and diagnostic feedback with load
current sense, integrated in Smart SIPMOS chip on chip technology. Providing embedded protective functions.
IN
Charge pump
Level shifter
Rectifier
Limit for
unclamped
ind. loads
Gate
protection
Current
limit
2
Overvoltage
protection
+ Vbb
PROFET
OUT
3 & Tab
1, 5
Load GND
Load
Output
Voltage
detection
RIS
IS
4
IIS
IL
VIS
IIN
Lo
g
ic GND
Voltage
sensor
Voltage
source
Current
Sense
Logic
ESD
Temperature
sensor
Rbb
VIN
Product Summary
Operating voltage Vbb(on) 5.5 ... 62 V
On-state resistance RON 20 m
Nominal current IL(nom) 5.5 A
Load current (ISO) IL(ISO) 17 A
Current limitation IL12(SC) 70 A
Package
PG-TO252-5-11
(DPAK 5 pin; less than half the size as TO 220 SMD)
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PROFET® BTS 6163 D
Data Sheet 2 of 18 Rev. 1.0, 2007-07-23
Pin Symbol Function
1 OUT O Output; output to the load; pin 1 and 5 must be externally shorted* .
2 IN I Input; activates the power switch if shorted to ground.
Tab/(3) Vbb + Supply Voltage; positive power supply voltage; tab and pin3 are internally
shorted.
4 IS S Sense Output; Diagnostic feedback; provides at normal operation a sense
current proportional to the load current; in case of overload,
overtemperature and/or short circuit a defined current is provided (see
Truth Table on page 8)
5 OUT O Output; output to the load; pin 1 and 5 must be externally shorted* .
*) Not shorting all outputs will considerably increase the on-state resistance, reduce the peak current capability
and decrease the current sense accuracy
Maximum Ratings at Tj = 25 °C unless otherwise specified
Parameter Symbol Values Unit
Supply voltage (overvoltage protection see page 4) Vbb 62 V
Supply voltage for full short circuit protection 1) Vbb 48 V
Load dump protection VLoadDump = UA + Vs, UA = 24 V
RI= 2 , RL= 4.4 , td= 400 ms, IN= low or high VLoad dum p 2)70 V
Load current (Short-circuit current, see page 5) IL self-limited A
Operating temperature range
Storage temperature range Tj
Tstg -40 ...+150
-55 ...+150 °C
Power dissipation (DC) Ptot 59 W
Inductive load switch-off energy dissipation, 3)
single pulse IL = 20 A, Vbb= 24V Tj=150 °C:
EAS 0.25 J
Electrostatic discharge capability (ESD)
(Human Body Model)
acc. ESD assn. std. S5.1-1993; R=1.5k; C=100pF
VESD 3.0
kV
Current through input pin (DC)
Current through current sense pin (DC)
see internal circuit diagrams page 9
IIN
IIS +15, -120
+15, -120 mA
Input voltage slew rate Vbb 16V :
Vbb > 16V 4):
dVbIN / dt self-limited
20 V/µs
1) Short circuit is defined as a combination of remaining resistances and inductances. See schematic on
page11.
2) VLoad dump is setup without the DUT connected to the generator per ISO 7637-1 and DIN 40839
3) See also diagram on page 11.
4) See also on page 8. Slew rate limitation can be achieved by means of using a series resistor RIN in the input
path. This resistor is also required for reverse operation. See also page 10.
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PROFET® BTS 6163 D
Data Sheet 3 of 18 Rev. 1.0, 2007-07-23
Thermal Characteristics
Parameter and Conditions Symbol Values Unit
min typ max
Thermal re sistance chip - case: RthJC -- -- 1.1 K/W
junction - ambient (free air): RthJA -- 80 --
SMD version, device on PCB 6): -- 45 55
Electrical Characteristics
Parameter and Conditions Symbol Values Unit
at Tj= 25, Vbb = 24 V unless otherwise specified min typ max
Load Switching Capabilities and Characteristics
On-state resistance (pin 3 to pin 1,5)
VIN= 0, Vbb= 5.5V, IL = 7.5 A Tj=25 °C:
Tj=150 °C:
VIN= 0, Vbb= 12..24V, IL = 7.5 A Tj=25 °C:
Tj=150 °C:
RON
--
--
--
--
19
38
16
32
25
50
20
40
m
Output voltage drop limitation at small load
currents (Tab to pin 1,5) 5) Tj=-40...150 °C: VON(NL) -- 40 65 mV
Nominal load current (Tab to pin 1,5)
ISO Proposal: VON 0.5 V, TC = 85°C, Tj 150°C
SMD 6), VON 0.5 V, TA = 85°C, Tj 150°C
IL(ISO)
IL(nom)
17
5.5
21.5
6.5 --
-- A
Turn-on time to 90% VOUT:
Turn-off time to 10% VOUT:
RL = 3.9 Ω, Tj=-40...150 °C
ton
toff --
-- 150
200 300
550 µs
Slew rate on
25 to 50% VOUT, RL = 3.9 Ω, Tj=-40...150 °C dV /dton -- 0.65 1.0 V/µs
Slew rate off
50 to 25% VOUT, RL = 3.9 Ω, Tj=-40...150 °C -dV/dtoff -- 0.65 1.2 V/µs
5) See figure 7a on page 15.
6) Device on 50mm*50mm*1.5mm epoxy PCB FR4 with 6cm2 (one layer, 70µm thick) copper area for Vbb
connection. PCB is vertical without blown air.
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PROFET® BTS 6163 D
Data Sheet 4 of 18 Rev. 1.0, 2007-07-23
Values Parameter and Conditions
at Tj= 25, Vbb = 24 V unless otherwise specified Symbol min. typ. max.
Unit
Operating Parameters
Operating voltage (VIN=0) Tj=-40...150 °C: Vbb(on) 5.5 -- 62 V
Undervoltage shutdown 7) 8) VbIN(u) -- 2.5 3.5 V
Undervoltage restart of charge pump
Vbb(ucp) -- 4 5.5 V
Overvoltage protection 9)
Ibb=15 mA VZ,IN 68
73
-- V
Standby current Tj=-40...+120°C:
IIN=0 T
j=150°C: Ibb(off) --
-- 3
6 6
14 µA
Reverse Battery
Reverse battery voltage 10) -Vbb -- -- 16 V
On-state resistance (pin 1,5 to pin 3)
Vbb= - 8V, VIN= 0, IL = -7.5 A, RIS = 1 k, 8)
Tj=25 °C:
Tj=150 °C:
Vbb= -12..-24V, VIN= 0, IL = -7.5 A, RIS = 1 k ,
Tj=25 °C:
Tj=150 °C:
RON(rev)
--
--
--
--
19
35
18
33
25
44
23
40
m
Integrated resistor in Vbb line Rbb -- 100 150
Inverse Operation 11)
Output voltage drop (pin 1,5 to pin 3) 8)
IL = -7.5 A, RIS = 1 k, Tj=25 °C:
IL = -7.5 A, RIS = 1 k, Tj=150 °C:
-VON(inv)
--
--
700
300 --
-- mV
Turn-on delay after inverse operation; IL > 0A 8)
VIN(inv) = VIN(fwd) = 0 V
td(inv)
--
1 -- ms
7) VbIN=Vbb-VIN see diagram page 14.
8) Not subject to production test, specified by design.
9) See also VON(CL) in circuit diagram page 9.
10) For operation at voltages higher then |16V| please see required schematic on page 10.
11) Permanent Inverse operation results eventually in a current flow via the intrinsic diode of the power DMOS.
In this case the device switches on with a time delay td(inv)) after the transition from inverse to forward mode.
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PROFET® BTS 6163 D
Data Sheet 5 of 18 Rev. 1.0, 2007-07-23
Values Parameter and Conditions
at Tj= 25, Vbb = 24 V unless otherwise specified Symbol min. typ. max.
Unit
Protection Functions 12)
Short circuit current limit (Tab to pin 1,5) 13)
Short circuit current limit at VON = 6V14) Tj =-40°C:
Tj =25°C:
Tj =+150°C:
IL6(SC) --
--
50
90
80
65
110
--
--
A
Short circuit current limit at VON = 12V 14) Tj =-40°C:
Tj =25°C:
Tj =+150°C:
IL12(SC) --
--
40
80
70
55
100
--
--
A
Short circuit current limit at VON = 18V 14) Tj =-40°C:
Tj =25°C:
Tj =+150°C:
IL18(SC) --
--
30
55
50
48
80
--
--
A
Short circuit current limit at VON = 24V Tj =-40°C:
tm=170µs Tj =25°C:
Tj =+150°C:
IL24(SC) --
--
25
45
40
35
60
--
--
A
Short circuit current limit at VON = 30V Tj =-40°C:
tm=170µs Tj =25°C:
Tj =+150°C:
IL30(SC) --
--
20
30
30
30
50
--
--
A
Short circuit current limit at VON = 45V 14) Tj =-40°C:
Tj =25°C:
Tj =+150°C:
IL45(SC) --
--
15
22
22
22
35
--
--
A
Short circuit shutdown detection voltage
(pin 3 to pins 1,5)
VON(SC)
2.5
3.5 4.5 V
Short circuit shutdown delay after input current
positive slope, VON > VON(SC), Tj = -40...+150°C
min. value valid only if input "off-signal" time exceeds 30 µs
td(SC1)
350
650 1200 µs
Short circuit shutdown delay during on condition13)
VON > VON(SC)
td(SC2)
--
2 -- µs
Output clamp (inductive load switch off) 15)
at VOUT = Vbb - VON(CL) (e.g. overvoltage)
IL= 40 mA
VON(CL)
63
67 -- V
Thermal overload trip temperature Tjt 150 175 -- °C
Thermal hysteresis
Tjt -- 10 -- K
12) Integrated protection functions are designed to prevent IC destruction under fault conditions described in the
data sheet. Fault conditions are considered as "outside" normal operating range. Protection functions are
not designed for continuous repetitive operation.
13) Short circuit current limit for max. duration of td(SC1) , prior to shutdown, see also figures 3.x on page 13.
14) Not subject to production test, specified by design.
15) See also figure 2b on page 12.
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PROFET® BTS 6163 D
Data Sheet 6 of 18 Rev. 1.0, 2007-07-23
Values Parameter and Conditions
at Tj= 25, Vbb = 24 V unless otherwise specified Symbol min. typ. max.
Unit
Diagnostic Characteristics
Current sense ratio, static on-condition
kILIS = IL : IIS, IIS < IIS,lim 16),
VIS <VOUT - 5 V, VbIN > 4.5 V
kILIS --
9000 --
IL = 30A, Tj = -40°C:
Tj = +25°C:
Tj = +150°C:
IL = 7.5A, Tj = -40°C:
Tj = +25°C:
Tj = +150°C:
IL = 2.5A, Tj = -40°C:
Tj = +25°C:
Tj = +150°C:
IL = 0.5A, Tj = -40°C:
Tj = +25°C:
Tj = +150°C:
8300
8200
8100
8200
8100
8000
7200
7500
7700
5000
6000
7500
9000
9000
8800
8900
8900
8700
8900
8900
8700
9500
10000
10500
10000
9800
9500
10000
9800
9500
11000
10600
10000
16000
15000
13000
IIN = 0 (e.g. during deenergizing of inductive loads): -- 0 --
Sense current under fault conditions 17)
VON>1V, typ Tj = -40...+150°C:
IIS,fault
4.0
5.2 7.5 mA
Sense current saturation
VON<1V, typ Tj = -40...+150°C:
IIS,lim
4.0
6.0 7.5 mA
Fault-Sense signal delay after input current positive
slope, VON >1V, Tj = -40...+150°C tdelay(fault) 350 650 1200 µs
Current sense leakage current, IIN = 0 IIS(LL) -- 0.1 0.5 µA
Current sense offset current, VIN = 0, IL 0 IIS(LH) -- 1.0 2.0 µA
Current sense settling time to IIS static after input
current positive slope, 18)
IL = 0 20 A, Tj= -40...+150°C
tson(IS)
--
250 500 µs
Current sense settling time during on condition, 18)
IL = 10 20 A, Tj= -40...+150°C
tslc(IS)
--
50 100 µs
Overvoltage protection
Ibb = 15 mA Tj = -40...+150°C:
VZ,IS
68
73 -- V
16) See also figures 4.x and 6.x on page 13 and 14.
17) Fault conditions are overload during on (i.e. VON>1V typ.), overtemperature and short circuit; see also truth
table on page 8.
18) Not subject to production test, specified by design.
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PROFET® BTS 6163 D
Data Sheet 7 of 18 Rev. 1.0, 2007-07-23
Values Parameter and Conditions
at Tj= 25, Vbb = 24 V unless otherwise specified Symbol min. typ. max.
Unit
Input
Required current capability of input switch
Tj =-40..+150°C: IIN(on) -- 1.6 2.4 mA
Input current for turn-off Tj =-40..+150°C: IIN(off) -- -- 30 µA
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PROFET® BTS 6163 D
Data Sheet 8 of 18 Rev. 1.0, 2007-07-23
Truth Table
Input
Current
level
Output
level
Current
Sense
IIS
Normal
operation L
H L
H 0 (IIS(LL))
nominal
Overload 19) L
H L
H 0 (IIS(LL))
IIS,fault
Short circuit to GND 20) L
H L
L 0 (IIS(LL))
IIS,fault
Overtemperature L
H L
L 0 (IIS(LL))
IIS,fault
Short circuit to Vbb L
H H
H 0 (IIS(LL))
<nominal 21)
Open load L
H Z
H 0 (IIS(LL))
0 (IIS(LH))
L = "Low" Level, Z = high impedance, potential depends on external circuit
H = "High" Level
Terms
PROFET
V
IN
IS
OUT
bb
VIN IIS
IIN
Vbb
Ibb
IL
VOUT
VON
2
4
3
1,5
RIS
VIS
VbIN
RIN
DS
VbIS
Two or more devices can easily be connected in
parallel to increase load current capability.
19) Overload is detected at the following condition: 1V (typ.) < VON < 3.5V (typ.). See also page 11.
20) Short Circuit is detected at the following condition: VON > 3.5V (typ.). See also page 11.
21) Low ohmic short to Vbb may reduce the output current IL and therefore also the sense current IIS.
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PROFET® BTS 6163 D
Data Sheet 9 of 18 Rev. 1.0, 2007-07-23
Input circuit (ESD protection)
IN
ZD
IN
I
Vbb
Rbb
VZ,IN
VbIN
VIN
ESD-Zener diode: 73 V typ.., max 15 mA;
Current sense output
Normal operation
IS
IS
R
ZD
IS
V
Vbb
Z,IS
V
Rbb
IIS
IIS,fault
VZ,IS = 73 V (typ.), RIS = 1 k nominal (or 1 k /n, if n
devices are connected in parallel). IS = IL/kilis can be
only driven by the internal circuit as long as
Vout - VIS > 5V. Therefore RIS should be less than
mA
VVbb
5.7
5.
Note: For large values of RIS the voltage VIS can reach
almost Vbb. See also overvoltage protection.
If you don't use the current sense output in your
application, you can leave it open.
Inductive and overvoltage output clamp
+ Vbb
OUT
PROFET
VZ1
VON
VON is clamped to VON(Cl) = 67 V typ
Overvoltage protection of logic part
+ Vbb
VOUT
IN
bb
R
Signal GND
Logic
PROFET
VZ,IS
RIS
IN
R
IS
VZ,IN
RVVZ,VIS
Rbb = 100 typ., VZ,IN = VZ,IS = 73 V typ., RIS = 1 k
nominal. Note that when overvoltage exceeds 73 V typ.
a voltage above 5V can occur between IS and GND, if
RV, VZ,VIS are not used.
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PROFET® BTS 6163 D
Data Sheet 10 of 18 Rev. 1.0, 2007-07-23
Reversave (Reverse battery protection)
Logic
IN
IS
R
OUT
L
R
Power GND
Signal GND
Vbb
-
Power
Transistor
IN
R
bb
R
D
RIS typ. 1 k. Add RIN for reverse battery protection in
applications with Vbb above 16V;
recommended value: =+
ISIN RR
11 VV
A
bb 12||
08.0
To minimise power dissipation at reverse battery
operation, the overall current into the IN and IS pin
should be about 80mA. The current can be provided by
using a small signal diode D in parallel to the input
switch, by using a MOSFET input switch or by proper
adjusting the current through RIS.
Since the current via Rbb generates additional heat in
the device, this has to be taken into account in the
overall thermal consideration.
Inverse load current operation
PROFET
V
IN OUT
IS
bb
Vbb
VOUT
- IL
RIS
VIS
VIN
+
-+
-
IIS
The device can be operated in inverse load current
mode (VOUT > Vbb > 0V). The current sense feature is
not available during this kind of operation (IIS = 0). In
case of inverse operation the intrinsic drain source
diode is eventually conducting resulting in considerably
increased power dissipation.
The transition from inverse to forward mode can result
in a delayed switch on.
Note: Temperature protection during inverse load
current operation is not possible!
Vbb disconnect with energised inductive
load
Provide a current path with load current capability by
using a diode, a Z-diode, or a varistor. (VZL+VD<63 V if
RIN = 0). For higher clamp voltages currents at IN and
IS have to be limited to 120 mA.
Version a:
PROFET
V
IN OUT
IS
bb
Vbb
VZL
VD
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PROFET® BTS 6163 D
Data Sheet 11 of 18 Rev. 1.0, 2007-07-23
Short circuit detection
Fault Condition: VON > VON(SC) (3.5 V typ.) and t> td(SC)
(typ.650 µs).
Overload detection
Fault Condition: VON > 1 V typ.
detection
circuit
Logic
unit
+ Vbb
OUT
VON
Short circuit
Short circuit is a combination of primary and
secondary impedance’s and a resistance’s.
PROFET
V
IN
OUT
IS
bb
RSC
IIN
Vbb ZL
SC
LSC
10mOhm
5uH
Allowable combinations of minimum, secondary
resistance for full protection at given secondary
inductance and supply voltage for single short circuit
event:
0
5
32V
10
0 100 200
RSC
[mOhm]
15
LSC
300
[uH] V :
bb 36V 40V
48V
Inductive load switch-off energy
dissipation
PROFET
V
IN OUT
IS
bb
E
E
E
EAS
bb
L
R
ELoad
L
R
L
{
Z
L
R
IS
I
IN
V
bb
i (t)
L
Energy stored in load inductance:
EL = 1/2·L·I2
L
While demagnetizing load inductance, the energy
dissipated in PROFET is
EAS= Ebb + EL - ER= VON(CL)·iL(t) dt,
with an approximate solution for RL > 0 :
EAS= IL· L
2·RL(Vbb + |VOUT(CL)|) ln (1+ IL·RL
|VOUT(CL)| )
Maximum allowable load inductance for
a single switch off
L = f (IL ); Tj,start = 150°C, Vbb = 24 V, RL = 0
0,01
0,1
1
10
100
1000
1 10 100
I_L [A]
L [mH]
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PROFET® BTS 6163 D
Data Sheet 12 of 18 Rev. 1.0, 2007-07-23
Timing diagrams
Figure 1a: Switching a resistive load,
change of load current in on-condition:
IIN
t
VOUT
IL
IIS tson(IS)
tt
slc(IS)
Load 1 Load 2
soff(IS)
t
t
t
on
off
slc(IS)
90%
dV/dton
dV/dtoff
10%
The sense signal is not valid during a settling time
after turn-on/off and after change of load current.
Figure 2a: Switching motors and lamps:
IIN
t
VOUT
IIL
IIS IIS
,
faut / I IS
,
lim
As long as VbIS < VZ,IS the sense current will never
exceed IIS,fault and/or IIS,lim.
Figure 2b: Switching an inductive load:
IIN
t
VOUT
IL
IIS
VON
(
CL
)
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PROFET® BTS 6163 D
Data Sheet 13 of 18 Rev. 1.0, 2007-07-23
Figure 3a: Typ. current limitation characteristic
0
20
40
60
80
VON
[A] IL(SC)
01020 [V]30
VON(SC) 50
In case of VON > VON(SC) (typ. 3.5 V) the device will
be switched off by internal short circuit detection.
Figure 3b: Short circuit type one:
shut down by short circuit detection, reset by IIN = 0.
IIN
IL
IL(SC)
IIS
t
td(SC1)
IIS,fault
tdelay(fault)
tm
VON > VON(SC)
Shut down remains latched until next reset via input.
Figure 3c: Short circuit type two:
shut down by short circuit detection, reset by IIN = 0.
IIN
IL
Internal Switch off
IIS
t
td(SC2)
IIS,fault
V
ON
IL
kilis
1V typ.
depending on the
external impedance
Shut down remains latched until next reset via input.
Figure 4a: Overtemperature
Reset if Tj<Tjt
IIN
t
IIS
VOUT
T
j
IIS,fault
A
uto Restart
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PROFET® BTS 6163 D
Data Sheet 14 of 18 Rev. 1.0, 2007-07-23
Figure 4b: Overload
Tj<Tjt
IIN
t
IL
Vbb
IS
-V OUT
V =1V typ.
ON
R *I
ON L,lim
IL
kilis
IIS,lim IIS,fault
Figure 5a: Undervoltage restart of charge pump,
overvoltage clamp
0
01012
VOUT
VbIN(ucp)
VIN = 0
IIN = 0
VON(CL)
VON(CL)
VbIN(u)
VbIN(u)
dynamic, short
Undervoltage
not below
Vbb
Figure 6a: Current sense versus load current:
0
1
2
01020
IL
[A]
[mA] IIS
30 40
3
IIS,lim
4
IIS(LH)
IL,lim
Figure 6b: Current sense ratio22:
10000
010 20
IL
[A]
kILIS
530
5000
15000
20000
22 This range for the current sense ratio refers to all
devices. The accuracy of the kILIS can be raised by
means of calibration the value of kILIS for every
single device.
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PROFET® BTS 6163 D
Data Sheet 15 of 18 Rev. 1.0, 2007-07-23
Figure 7a: Output voltage drop versus load current:
0.0
0.05
0.1
0 1 2 3 4 5 6 7
IL
[A]
[V] V
ON
ON(NL)
V
ON
R
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PROFET® BTS 6163 D
Data Sheet 16 of 18 Rev. 1.0, 2007-07-23
Package Outlines
All dimensions in mm
D-Pak-5 Pin: PG-TO252-5-11
Sales Code BTS6163D
Green Product (RoHS compliant)
To meet the world-wide customer requirements for environmentally friendly products and to be compliant with
government regulations the device is available as a green product. Green products are RoHS-Compliant (i.e Pb-
free finish on leads and suitable for Pb-free soldering according to IPC/JEDEC J-STD-020).
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PROFET® BTS 6163 D
Data Sheet 17 of 18 Rev. 1.0, 2007-07-23
Revision History
Version Date Changes
Rev. 1.0 2007-02-21 RoHS-compliant version of BTS6163D
Page 1, page 16: RoHS compliance statement and Green product feature added
Page 1, page 16: Change to RoHS compliant package PG-TO252-5-11
Legal disclaimer updated
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Edition 2007-07-23
Published by
Infineon Technologies AG
81726 Munich, Germany
© 2007 Infineon Technologies AG.
All Rights Reserved.
Legal Disclaimer
The information given in this document shall in no event be regarded as a guarantee of conditions or
characteristics. With respect to any examples or hints given herein, any typical values stated herein and/or any
information regarding the application of the device, Infineon Technologies hereby disclaims any and all
warranties and liabilities of any kind, including without limitation, warranties of non-infringement of intellectual
property rights of any third party.
Information
For further information on technology, delivery terms and conditions and prices please contact your nearest
Infineon Technologies Office (www.infineon.com).
Warnings
Due to technical requirements components may contain dangerous substances. For information on the types in
question please contact your nearest Infineon Technologies Office.
Infineon Technologies components may only be used in life-support devices or systems with the express written
approval of Infineon Technologies, if a failure of such components can reasonably be expected to cause the
failure of that life-support device or system, or to affect the safety or effectiveness of that device or system. Life
support devices or systems are intended to be implanted in the human body or to support and/or maintain and
sustain and/or protect human life. If they fail, it is reasonable to assume that the health of the user or other
persons may be endangered.
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