10 FZ07NBA075SM P916L58 D1 14

10-FZ07NBA075SM-P916L58
datasheet
flow BOOST 0 symmetric
650 V / 75 A
Features
●
●
●
●
flow 0 12mm housing
High efficiency symmetric boost
Ultra high switching frequency
Clip-In PCB mounting
Low Inductance Layout
Schematic
Target applications
● Solar inverters
● UPS
● Power supplies
Types
● 10-FZ07NBA075SM-P916L58
Maximum Ratings
Tj = 25 °C, unless otherwise specified
Parameter
Symbol
Condition
Value
Unit
650
V
57
A
225
A
97
W
Boost Switch
Collector-emitter voltage
Collector current
V CES
IC
T j = T jmax
T s = 80 °C
Repetitive peak collector current
I CRM
t p limited by T jmax
Total power dissipation
P tot
T j = T jmax
Gate-emitter voltage
V GES
±20
V
Maximum Junction Temperature
T jmax
175
°C
Copyright Vincotech
T s = 80 °C
1
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Maximum Ratings
Tj = 25 °C, unless otherwise specified
Parameter
Symbol
Condition
Value
Unit
650
V
59
A
150
A
78
W
Boost Diode
Peak Repetitive Reverse Voltage
Continuous (direct) forward current
V RRM
IF
T j = T jmax
T s = 80°C
Repetitive peak forward current
I FRM
Total power dissipation
P tot
Maximum Junction Temperature
T jmax
175
°C
V RRM
650
V
36
A
60
A
61
W
T j = T jmax
T s = 80°C
Boost Inverse Diode
Peak Repetitive Reverse Voltage
Continuous (direct) forward current
IF
T j = T jmax
T s = 80°C
Repetitive peak forward current
I FRM
Total power dissipation
P tot
Maximum Junction Temperature
T jmax
175
°C
Storage temperature
T stg
-40…+125
°C
Operation temperature under switching
condition
T jop
-40…+(T jmax - 25)
°C
4000
V
min. 12,7
mm
9,53
mm
T j = T jmax
T s = 80°C
Module Properties
Thermal Properties
Isolation Properties
Isolation voltage
V isol
DC Voltage
Creepage distance
Clearance
Comparative Tracking Index
Copyright Vincotech
tp = 2 s
> 200
CTI
2
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Characteristic Values
Parameter
Conditions
Symbol
VCE [V]
VGE [V]
VGS [V]
VGS [V]
Vr [V]
Value
IC [A]
ID [A]
IF [A]
Tj [°C]
Unit
Min
Typ
Max
3,3
4
4,7
25
1,67
2,22
125
1,84
150
1,89
Boost Switch
Static
Gate-emitter threshold voltage
V GE(th)
Collec tor-emitter saturation voltage
V CEsat
V GE = V CE
0,00075 25
15
75
V
V
Collec tor-emitter c ut-off current
I CES
0
650
25
40
µA
Gate-emitter leakage c urrent
I GES
20
0
25
120
nA
Internal gate resistance
rg
none
Input capacitance
C ies
4300
Output capacitance
C oes
Reverse transfer capac itance
C res
Gate c harge
Qg
f = 1 MHz
0
25
25
75
Ω
pF
16
15
520
75
25
166
nC
0,98
K/W
Thermal
Thermal resistance junc tion to sink
R th(j-s)
phase-change
material
ʎ = 3,4 W /mK
IGBT Switching
Turn-on delay time
t d(on)
R goff = 4 Ω
Rise time
Turn-off delay time
tr
R gon = 4 Ω
t d(off)
15/0
Fall time
tf
Turn-on energy (per pulse)
E on
Turn-off energy (per pulse)
E off
Copyright Vincotech
Q rFWD = 2,4 µC
Q rFWD = 4,6 µC
Q rFWD = 5,3 µC
3
350
75
25
125
150
25
125
150
25
125
150
25
125
150
25
125
150
25
125
150
23
23
23
14
15
16
116
131
135
4
8
10
1,058
1,486
1,591
0,277
0,481
0,527
ns
mWs
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Characteristic Values
Parameter
Conditions
Symbol
VCE [V]
VGE [V]
VGS [V]
VGS [V]
Vr [V]
Value
IC [A]
ID [A]
IF [A]
Tj [°C]
Min
Unit
Typ
Max
25
1,53
1,77
125
1,49
150
1,47
Boost Diode
Static
Forward voltage
Reverse leakage c urrent
75
VF
650
Ir
25
V
3,8
µA
Thermal
Thermal resistance junc tion to sink
R th(j-s)
phase-change
material
ʎ = 3,4 W /mK
1,23
K/W
FWD Switching
Peak recovery current
I RRM
Reverse recovery time
t rr
Recovered charge
Qr
Reverse recovered energy
Peak rate of fall of recovery current
di /dt = 5120 A/µs
di /dt = 4804 A/µs 15/0
di /dt = 5399 A/µs
350
75
E rec
(di rf/dt )max
25
125
150
25
125
150
25
125
150
25
125
150
25
125
150
51
69
74
84
109
123
2,383
4,616
5,343
0,511
1,036
1,222
750
682
570
A
ns
µC
mWs
A/µs
Boost Inverse Diode
Static
Forward voltage
VF
Reverse leakage c urrent
Ir
30
650
25
1,64
150
1,56
25
1,87
0,36
V
µA
Thermal
Thermal resistance junc tion to sink
Copyright Vincotech
R th(j-s)
phase-change
material
ʎ = 3,4 W /mK
1,56
4
K/W
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Characteristic Values
Parameter
Conditions
Symbol
VCE [V]
VGE [V]
VGS [V]
VGS [V]
Vr [V]
Value
IC [A]
ID [A]
IF [A]
Tj [°C]
Min
Typ
Unit
Max
Thermistor
Rated resistance
25
R
Deviation of R100
ΔR/R
Power dissipation
P
100
R 100 = 1484 Ω
Power dissipation constant
22
-5
kΩ
5
%
25
5
mW
25
1,5
mW/K
B-value
B(25/50)
Tol. ±1%
25
3962
K
B-value
B(25/100) Tol. ±1%
25
4000
K
Vincotech NTC Reference
Copyright Vincotech
I
5
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switch Characteristics
Typical output characteristics
IGBT
Typical output characteristics
I C = f(V CE)
IGBT
I C = f(V CE)
200
I C (A)
I C (A)
200
150
150
100
100
50
50
0
0
0
1
2
3
4
0
5
1
2
3
4
5
V C E (V)
V C E (V)
tp =
250
µs
V GE =
15
V
25
T j:
°C
tp =
250
125 °C
Tj =
150
150 °C
V GE from
8 V to 17 V in steps of 1 V
Typical transfer characteristics
IGBT
µs
°C
Transient Thermal Impedance as function of Pulse duration
I C = f(V GE)
IGBT
Z th(j-s) = f(t p)
75
Z t h(j
h(j--s)(K/W)
I C (A)
101
60
100
45
10-1
30
0,5
0,2
0,1
10-2
0,05
15
0,02
0,01
0,005
0
10-3
10-5
0
0
1
2
3
4
5
6
7
10-4
10-3
10-2
V G E (V)
tp =
100
µs
V CE =
10
V
25
T j:
°C
D =
125 °C
Copyright Vincotech
10
101
t p (s)
102
tp / T
R th(j-s) =
150 °C
10-1
0,98
K/W
IGBT thermal model values
6
R (K/W)
7,21E-02
τ (s)
2,25E+00
1,46E-01
3,32E-01
4,74E-01
6,42E-02
1,76E-01
1,63E-02
6,17E-02
3,99E-03
4,63E-02
3,57E-04
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switch Characteristics
Gate voltage vs Gate charge
IGBT
Safe operating area
V GE = f(Q G)
IGBT
I C = f(V CE)
I C (A)
1000
V G E (V)
15
130V
12,5
100
520V
10
10
7,5
1
5
0,1
2,5
0
0,01
0
20
40
60
80
100
120
140
160
1
180
10
Q G (nC)
1000
V C E (V)
At
I C=
100
At
75
Copyright Vincotech
A
7
D =
single pulse
Th =
80
ºC
V GE =
Tj =
±15
T jmax
V
ºC
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Diode Characteristics
FWD
Typical forward characteristics
FWD
Transient thermal impedance as a function of pulse width
I F = f(V F)
Z th(j-s) = f(t p)
250
Z t h(j
h(j--s) (K/W)
IF (A)
101
200
100
150
100
D = 0,5
0,2
0,1
0,05
0,02
0,01
0,005
0,000
10-1
50
10-2
0
0
1
2
3
4
10-4
5
10-3
10-2
VF (V)
tp =
250
µs
25
T j:
10-1
100
101
102
t p (s)
°C
125 °C
D=
tp / T
R th(j-s) =
1,23
K/W
150 °C
FWD thermal model values
R (K/W)
Copyright Vincotech
8
8,04E-02
τ (s)
2,68E+00
1,74E-01
2,85E-01
6,28E-01
6,23E-02
2,05E-01
1,65E-02
8,90E-02
4,15E-03
4,76E-02
4,96E-04
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Inverse Diode Characteristics
FWD
Typical forward characteristics
I F = f(V F)
Z th(j-s) = f(t p)
90
101
Z t h(j
h(j--s) (K/W)
IF (A)
FWD
Transient thermal impedance as a function of pulse width
75
100
60
45
D = 0,5
0,2
0,1
0,05
0,02
0,01
0,005
0,000
10-1
30
15
10-2
0
0
1
2
3
4
10-4
5
10-3
10-2
VF (V)
tp =
250
µs
T j:
25
10-1
100
101
102
t p (s)
°C
150 °C
D=
tp / T
R th(j-s) =
1,56
K/W
FWD thermal model values
R (K/W)
9,10E-02
τ (s)
2,00E+00
3,45E-01
1,68E-01
7,17E-01
4,13E-02
2,97E-01
7,43E-03
1,15E-01
1,80E-03
Thermistor Characteristics
Typical Thermistor resistance values
Thermistor typical temperature characteristic
Typical NTC characteristic
as a function of temperature
R T = f(T )
NTC-typical temperature characteristic
R (Ω)
25000
20000
15000
10000
5000
0
25
50
75
100
125
T (°C)
Copyright Vincotech
9
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switching Characteristics
Figure 1.
IGBT
Figure 2.
IGBT
Typical swit ching energy losses as a f unct ion of gate resistor
E = f(I C)
E = f(rg)
3
E (mWs)
E (mWs)
Typical swit ching energy losses as a f unction of collector current
Eon
Eon
2,5
3
Eon
2,5
Eon
Eo n
2
2
Eo n
1,5
1,5
Eoff
1
1
Eoff
E o ff
0,5
Eoff
Eoff
0,5
Eo ff
0
0
0
25
50
75
100
125
150
0
I C (A)
25
With an induc tive load at
350
V
V CE =
15/0
V
V GE =
R gon =
4
Ω
R goff =
4
Ω
°C
4
6
8
150 °C
75
IC =
Figure 3.
FWD
10
T j:
14
16
R g ( Ω)
125 °C
150 °C
Figure 4.
FWD
E rec = f(I c)
E rec = f(r g )
2
1,6
E (mWs)
Typical reverse recovered energy loss as a f unct ion of gat e resist or
Erec
18
°C
A
Typical reverse recovered energy loss as a f unction of collector current
E (mWs)
12
25
With an inductive load at
350
V
V CE =
15/0
V
V GE =
125 °C
T j:
2
Erec
1,2
1,5
Erec
Erec
0,8
1
Erec
Erec
0,4
0,5
0
0
0
25
50
With an induc tive load at
350
V
V CE =
15/0
V
V GE =
R gon =
4
Copyright Vincotech
75
100
25
T j:
125
I C (A)
0
150
°C
2
4
6
With an inductive load at
350
V
V CE =
15/0
V
V GE =
125 °C
150 °C
Ω
IC=
10
75
8
10
12
25
T j:
14
16
r g (Ω)
18
°C
125 °C
150 °C
A
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switching Characteristics
Figure 5.
IGBT
Figure 6.
IGBT
Typical swit ching t imes as a f unct ion of collector current
Typical swit ching t imes as a f unct ion of gate resistor
t = f(I C)
t = f(r g)
1
t ( μs)
t ( μ s)
1
td(off )
td(off )
0,1
0,1
td(on)
tr
td(on)
tf
0,01
tf
0,01
tr
0,001
0,001
0
25
50
75
100
125
150
0
I C (A)
(A)
With an induc tive load at
150
°C
Tj=
350
V
V CE =
2
4
6
8
10
12
14
16
18
With an inductive load at
150
°C
Tj=
350
V
V CE =
V GE =
15/0
V
V GE =
R gon =
4
Ω
IC =
R goff =
4
Ω
Figure 7.
FWD
15/0
V
75
A
Figure 8.
Typical reverse recovery t ime as a f unction of collector current
FWD
Typical reverse recovery t ime as a f unct ion of IGBT t urn on gat e resist or
t rr = f(I C)
t rr = f(R gon)
0,16
t rr (μs)
t r r (μs)
0,16
trr
trr
trr
trr
0,12
0,12
trr
trr
0,08
0,08
0,04
0,04
0
0
0
25
50
75
100
125
150
0
I C (A)
At
r g (Ω)
350
V
V GE =
15/0
V
R gon =
4
Ω
V CE=
Copyright Vincotech
25
T j:
2
4
6
8
10
12
14
16
18
R g on (Ω)
°C
At
V CE =
125 °C
V GE =
150 °C
IC=
11
350
V
15/0
V
75
A
25
T j:
°C
125 °C
150 °C
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switching Characteristics
Figure 9.
FWD
Figure 10.
FWD
Typical recovered charge as a f unction of collector current
Typical recoved charge as a f unct ion of IGBT t urn on gate resistor
Q r = f(I C)
Q r = f(R gon)
Q r (µC)
Q r (μ C)
8
Qr
Qr
6
Qr
5
Qr
6
4
4
3
Qr
Qr
2
2
1
0
At
0
0
25
50
75
100
125
150
0
2
4
6
8
10
12
14
16
I C (A)
350
V
V GE =
15/0
V
R gon =
4
Ω
V CE =
At
25
T j:
°C
At
VCE=
125 °C
V GE =
150 °C
I C=
Figure 11.
FWD
350
V
15/0
V
75
A
25
T j:
125 °C
150 °C
Figure 12.
FWD
Typical peak reverse recovery current current as a f unct ion of collect or current
Typical peak reverse recovery current as a f unct ion of IGBT t urn on gate resist or
I RM = f(I C)
I RM = f(R gon)
100
18
R g o n (Ω)
°C
I R M (A)
I R M (A)
120
IRM
80
90
I RM
60
I RM
60
IRM
I RM
40
IRM
30
20
0
0
0
At
25
50
350
V
V GE =
15/0
V
R gon =
4
Ω
V CE =
Copyright Vincotech
75
100
25
T j:
125
I C (A)
0
150
2
4
6
8
10
12
14
16
18
R g o n (Ω)
°C
At
V CE =
125 °C
V GE =
150 °C
IC=
12
350
V
15/0
V
75
A
25
T j:
°C
125 °C
150 °C
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switching Characteristics
Figure 13.
FWD
Figure 14.
FWD
Typical rat e of f all of f orward and reverse recovery current as a f unction of IGBT t urn on gat e resist or
di F/dt ,di rr/dt = f(I c)
di F/dt ,di rr/dt = f(R g)
6000
d i /dt (A/
(A/µ
µs)
d i /dt (A/
(A/µs)
s)
Typical rat e of f all of f orward and reverse recovery current as a f unct ion of collect or current
diF / dt
dir r/dt
5000
7500
di F / dt
di r r/ dt
6000
4000
4500
3000
3000
2000
1500
1000
0
0
0
25
50
75
100
125
0
150
2
4
6
8
10
12
14
I C (A)
350
V
V GE =
15/0
V
R gon =
4
Ω
V CE =
At
25
T j:
°C
At
V CE =
125 °C
V GE =
150 °C
I C=
Figure 15.
350
V
15/0
V
75
A
25
T j:
16
18
R g o n (Ω)
°C
125 °C
150 °C
IGBT
Reverse bias saf e operating area
I C = f(V CE)
I C (A)
175
I C MAX
I c CHIP
150
125
M ODULE
100
Ic
75
V CE MAX
50
25
0
0
100
200
300
400
500
600
700
V C E (V)
At
175
°C
R gon =
4
Ω
R goff =
4
Ω
Tj =
Copyright Vincotech
13
22 Feb. 2016 / Revision 1
10-FZ07NBA075SM-P916L58
datasheet
Boost Switching Definitions
General conditions
=
125 °C
=
4Ω
Tj
R gon
=
R goff
Figure 1.
IGBT
4Ω
Figure 2.
Turn-of f Swit ching Wavef orms & def init ion of t dof f , t Eof f (t Eof f = int egrat ing t ime f or Eof f )
IGBT
Turn-on Swit ching Wavef orms & def init ion of tdon, t Eon (t Eon = int egrating t ime f or Eon)
150
200
%
%
IC
tdoff
150
100
VCE 90%
VGE 90%
VCE
100
IC
VGE
50
tEoff
VGE
tdon
50
IC 1%
VCE
VGE 10%
0
-50
-0,1
-0,05
0
0,05
0,1
0,15
-50
2,96
0,2
VCE 3%
IC 10%
0
tEon
3
3,04
3,08
3,12
3,16
t (µs)
0
V
V GE (100%) =
15
V
V C (100%) =
350
V
I C (100%) =
75
A
t doff =
t Eoff =
0,131
0,179
µs
µs
V GE (0%) =
Figure 3.
3,2
3,24
t (µs)
0
V
V GE (100%) =
15
V
V C (100%) =
350
V
I C (100%) =
75
A
t don =
t Eon =
0,023
0,124
µs
µs
V GE (0%) =
IGBT
Figure 4.
Turn-of f Swit ching Wavef orms & def init ion of t f
IGBT
Turn-on Swit ching Wavef orms & def init ion of tr
200
150
%
%
125
fitted
IC
175
IC
150
100
IC 90%
125
75
100
IC 90%
IC 60%
50
75
IC 40%
tr
50
25
IC10%
VCE
0
-25
0,05
0,07
0,09
0,11
0,13
-25
3,01
0,15
t ( µs)
V C (100%) =
350
VCE
25
tf
0
IC 10%
3,03
3,05
3,07
3,09
V C (100%) =
350
3,13
3,15
V
I C (100%) =
75
A
I C (100%) =
75
A
tf=
0,008
µs
tr =
0,015
µs
Copyright Vincotech
3,11
t (µs)
V
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22 Feb. 2016 / Revision 1
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datasheet
Boost Switching Definitions
Figure 5.
IGBT
Figure 6.
Turn-of f Swit ching Wavef orms & def init ion of t Eof f
IGBT
Turn-on Swit ching Wavef orms & def init ion of tEon
125
150
Eoff
%
%
Poff
Pon
125
100
Eon
100
75
IC 1%
75
50
50
25
25
VGE 90%
0
tEoff
-25
-0,06
VCE 3%
VGE 10%
0
-0,01
0,04
0,09
0,14
-25
2,97
0,19
tEon
3,01
3,05
3,09
P off (100%) =
26,34
kW
P on (100%) =
26,34
kW
E off (100%) =
0,48
mJ
E on (100%) =
1,49
mJ
t Eoff =
0,18
µs
t Eon =
0,12
µs
Figure 7.
3,13
3,17
t ( µs)
t (µs)
FWD
Turn-of f Swit ching Wavef orms & def init ion of t rr
150
%
Id
100
trr
50
fitted
Vd
0
IRRM 10%
-50
IRRM 90%
IRRM 100%
-100
-150
3
3,02
3,04
3,06
3,08
3,1
3,12
3,14
3,16
3,18
t (µs)
V d (100%) =
350
V
I d (100%) =
75
A
I RRM (100%) =
-69
A
t rr =
0,109
µs
Copyright Vincotech
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22 Feb. 2016 / Revision 1
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datasheet
Boost Switching Definitions
Figure 8.
FWD
Figure 9.
Turn-on Switching Waveforms & definition of tQrr (tQrr = integrating time for Qrr)
FWD
Turn-on Switching Waveforms & definition of tErec (tErec= integrating time for Erec)
125
150
%
%
Id
Qrr
tErec
75
tQrr
50
Erec
100
100
50
0
25
Prec
-50
0
-100
3
3,05
3,1
3,15
3,2
3,25
-25
3,3
3
t (µs)
3,05
3,1
3,15
3,25
3,3
t (µs)
I d (100%) =
75
A
P rec (100%) =
26,34
kW
Q rr (100%) =
4,62
µC
E rec (100%) =
1,04
mJ
t Qrr =
0,22
µs
t Erec =
0,22
µs
Copyright Vincotech
3,2
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datasheet
Ordering Code & Marking
Version
without thermal paste 12mm housing with solder pins
NN-NNNNNNNNNNNNNN
TTTTTTVV WWYY UL
Vinco LLLLL SSSS
Ordering Code
10-FZ07NBA075SM-P916L58
Text
Datamatrix
Name
Date code
UL & Vinco
Lot
Serial
NN-NNNNNNNNNNNNNN-TTTTTTVV
WWYY
UL Vinco
LLLLL
SSSS
Type&Ver
Lot number
Serial
Date code
TTTTTTTVV
LLLLL
SSSS
WWYY
Outline
Pin
Pin table
X
Y
Function
1
33,6
0
2
30,6
0
S1
3
23,65
0
+GND
4
20,65
0
+GND
5
14,9
0
+DC
6
11,9
0
+DC
7
G1
Not assembled
8
Not assembled
9
0
7,8
+Boost
10
3
7,8
+Boost
11
12
0
3
14,8
14,8
-Boost
-Boost
13
Not assembled
14
Not assembled
15
11,9
22,6
16
14,9
22,6
-DC
17
20,65
22,6
-GND
18
23,65
22,6
-GND
19
30,6
22,6
S2
20
33,6
22,6
G2
21
22
33,6
33,6
14,55
8,05
NTC1
NTC2
Copyright Vincotech
-DC
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10-FZ07NBA075SM-P916L58
datasheet
Pinout
Identification
ID
Component
Voltage
Current
Function
T1,T2
IGBT
650 V
75 A
Boost Switch
D1,D2
FWD
650 V
75 A
Boost Diode
D5,D6
FWD
650 V
30 A
Boost Inverse Diode
T
NTC
Copyright Vincotech
Comment
Thermistor
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10-FZ07NBA075SM-P916L58
datasheet
Packaging instruction
Standard packaging quantity (SPQ)
135
>SPQ
Standard
<SPQ
Sample
Handling instruction
Handling instructions for flow 0 packages see vincotech.com website.
Package data
Package data for flow 0 packages see vincotech.com website.
Document No.:
Date:
10-FZ07NBA075SM-P916L58-D1-14
22 Feb. 2016
Modification:
Pages
DISCLAIMER
The information, specifications, procedures, methods and recommendations herein (together “information”) are presented by Vincotech to
reader in good faith, are believed to be accurate and reliable, but may well be incomplete and/or not applicable to all conditions or situations
that may exist or occur. Vincotech reserves the right to make any changes without further notice to any products to improve reliability,
function or design. No representation, guarantee or warranty is made to reader as to the accuracy, reliability or completeness of said
information or that the application or use of any of the same will avoid hazards, accidents, losses, damages or injury of any kind to persons
or property or that the same will not infringe third parties rights or give desired results. It is reader’s sole responsibility to test and determine
the suitability of the information and the product for reader’s intended use.
LIFE SUPPORT POLICY
Vincotech products are not authorised for use as critical components in life support devices or systems without the express written approval
of Vincotech.
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, or (c) whose failure to perform when properly used in accordance with instructions for use provided in labelling can be
reasonably expected to result in significant injury to the user.
2. A critical component is 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.
Copyright Vincotech
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22 Feb. 2016 / Revision 1
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