®
S5
The world-leading perfusion system
Cardiac surgery solutions
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Please refer to regional marketing team for any questions you may have related to current or future product availability.
INDEX
Page
S5
®
CONCEPT
MAST ROLLER PUMPS
ROLLER PUMPS
CP5 CENTRIFUGAL PUMP
TUBING CLAMPS
SYSTEM PANEL
TIMERS
PRESSURE CONTROL
TEMPERATURE MONITOR
LEVEL CONTROL
BUBBLE DETECTOR
CARDIOPLEGIA CONTROL
4 – 6
7
8
9 - 10
11 - 12
13 - 14
14
15
16
17
18
29
B-CAPTA
ELECTRONIC GAS BLENDER
VENOUS LINE CLAMP
EVO - ELECTRICAL VENOUS OCCLUDER
ACCESSORIES
HEATER-COOLER 3T
CONNECT
TECHNICAL SPECIFICATIONS
20 - 21
22
23
24
25 – 27
28
29 – 31
32 - 35
3
®
S5
READY TO MEET ANY CHALLENGE
THE CONCEPT
High quality design.
Functional and easy to use.
Fully configurable modular concept.
S5 can be configured according to
the clinical need by adapting pump
numbers and modules.
Technical claims supported by LivaNova data on file
4
CONSOLE
S5 console
The console housing accommodates
the entire electronics of the E/P pack
including the central power supply and
the uninterruptible emergency power
supply. The four castors of the console
can be locked separately.
S5 pump table
This stainless steel pump table is
screwed to the console. Stainless
steel pins on the pump table are used
for mounting and securing the pump
housing. Pump tables for 3, 4 or 5
pumps can be supplied.
S5
®
S5 standard mast system
The standard mast system is fixed to
the console and includes:
Two fixed telescope masts and an
adjustable vertical mast with an
infusion rack. The masts can be used
for mounting the S5 system panel
and additional accessories and
disposables. The height of all masts
can be adjusted.
Two height-adjustable push bars on
the left and right side of the console
can be used when transporting the S5.
They can also be used for mounting
accessories.
A horizontal mast stabilises the
mast system.
Consoles with E/P pack
and standard mast system
S5 console
Mast systems
Telescope mast with infusion rack
Telescope mast, movable
with infusion rack
Part numberProduct designation
3-position
4-position 5-position
48-30-00Z 48-40-00Z 48-50-00Z
Size 3 Size 4 Size 5
all sizes: 48-30-50
all sizes: 48-30-51
Technical claims supported by LivaNova data on file
Push bar (horizontal) all sizes: 48-30-57
Push bar mast (vertical) all sizes: 48-30-67
“C”-shaped holder
Horizontal mast
Crossbar for movable mast
48-30-77
48-30-81
all sizes: 50-70-57
48-30-78
48-30-82
(horizontal)
5
48-30-79
48-30-83
®
S5
MAST SYSTEM EXTENSION
S5 Mast System Extension
The S5 mast system extension can
accommodate up to 3 mast roller
pumps. The mast system extension can
be mounted on the left or on the right
side of the console and folded prior to
transport. A supporting castor is used
to stabilise the mast system. The mast
system extension can be used to place
the pumps, oxygenator and tubing set
right beside the patient.
consisting of:
Working position 2
Working position 1
Transport position
Part numberProduct designation
50-45-00S5 mast system extension
Swivel telescope mast with infusion rack and castor
50-45-05
2 swivel arms 50-45-10
Vertical mast (including 2 horizontal masts) 50-45-15
Transport locking arm
Technical claims supported by LivaNova data on file
50-45-20
6
MAST ROLLER PUMPS
S5
Roller pumps can rotate in 15° increments; total rotation 180° for RP150 and
240° for DRP85.
Part numberProduct designation
®
Mast roller pump system 85
consisting of:
1x mast roller pump 85
(connection cable supplied)
Control panel for mast roller pump 150/85
(connection cable supplied)
Mast roller pump system 150
consisting of:
Mast roller pump 150
(connection cable supplied)
Control panel for mast roller pump 150/85
(connection cable supplied)
50-80-70Z
10-88-60
28-95-80Z
Part numberProduct designation
50-80-00Z
10-88-00
28-95-80Z
Part numberProduct designation
Mast roller pump system 85
consisting of:
2x mast roller pumps 85
(connection cable supplied)
Control panel for mast roller pump 85
(connection cable supplied)
Mast roller pump system with 2 MRP 85
consisting of:
2x mast roller pumps 85
(connection cable supplied)
Control panel for 2 mast roller pumps 85
(connection cable supplied)
Double holder (fixed)
50-80-60Z
10-88-60
28-95-85Z
Part numberProduct designation
50-80-62Z
10-88-60
28-95-85Z
Technical claims supported by LivaNova data on file
7
®
S5
ROLLER PUMPS
S5 roller pump
Roller pumps can rotate in 15°
increments; total rotation 180° for
RP150 and 240° for DRP85.
S5 double roller pump
The S5 double roller pump
combines two roller pumps with a
diameter of 85 mm in a single housing.
Both roller pumps can be operated
and controlled independently.
Each pump can be operated in
continuous or pulse mode.
Every pump has an independent control system and its own pump control panel
that is operated using a high-contrast colour touch screen.
The pumps can be individually configured, i.e. the monitoring functions can be
individually assigned to each pump and displayed on the touch screen.
A knob (incremental shaft encoder) is used to adjust the set speed electronically.
A maximum of five roller pumps can be placed on the console pump table and
connected to the E/P pack.
Part numberProduct designation
S5 roller pump 150 / S5 RP 150 10-80-00Z
S5 double roller pump 85 / S5 DRP 85 10-85-00Z
Technical claims supported by LivaNova data on file
8
CP5 CENTRIFUGAL PUMP
CP5 centrifugal pump
The easy to use "all in one" centrifugal pump system, including centrifugal driver, panel control module,
flowmeter, emergency driver and optional arterial clamp.
CP5 is designed with a maximum degree of programming flexibility and customization.
CP5 can be flexibly positioned via the rotating arm articulations.
CP5 can be easly mounted on the masts with the fast clamp.
CP5 can be easly configurated via the control panel.
The geometry of the CP5 makes it easy to clean: smooth plain surfaces
without sharp edges.
CP5 sophisticated flow control mode is like an extra set of hands during the case.
As pressure fluctuations occur with the patient and the circuit, it automatically
maintains set flow for the perfusionist.
CP5 can be linked to level, bubble and pressure alarms that can completely
occlude the arterial line via the ERC.
S5
®
Electrical Remote-Controlled Tubing Clamp (ERC)
The Electrical Remote-Controlled Tubing Clamp (ERC) is designed for operation with the CP5 system to improve for the
safety of centrifugal perfusion.
When certain conditions are detected (low level, bubble or retrograde flow), the ERC occludes the arterial line immedi-
ately to minImize the danger of air delivery.
If an alarm is triggered, the ERC closes the arterial line in a fraction of a second (e.g. retrograde flow, level or bubble alarm),
keeping the danger of air delivery to a minimum.
S5 allow simultaneous use of up to 2 centrifugal pump drivers:
on for arterial and one for venous kinetic drainage applications.
Technical claims supported by LivaNova data on file
9
®
1364
92
2.85
100
mmHg
-14
mmHg
%
l/min
rpm
CP5
Pressure 1
S5
CP5 CENTRIFUGAL PUMP
Part numberProduct designation
CP5 (only for S5|C5)
consisting of:
CP5 drive unit (with cable)
Pump control panel (with holder)
Emergency system (complete)
Flow sensor (3/8")
Flow measurement sensor module
CP5 console
60-00-60Z
60-01-04
60-02-60Z
60-01-35
96-414-140
25-60-70Z
48-20-00
Electrical Remote-Controlled Tubing Clamp (ERC)
Part numberProduct designation
Electrical remote-controlled tubing clamp
consisting of: tubing clamp,
3-joint mast holder with fast clamp connector,
500 mm
Electrical remote-controlled tubing clamp
consisting of: tubing clamp,
3-joint mast holder with fast clamp connector,
620 mm
Technical claims supported by LivaNova data on file
60-05-60
60-05-65
10
TUBING CLAMPS
Tubing clamp inserts
are available for all tubing sizes. They
are inserted into the tubing clamp
block of the pump heads.
Cardioplegia tubing clamp inserts allow
two tubes with different diameters to
be simultaneously connected to the
roller pump heads. They are available
for flow ratios from 1:1 to 8:1.
S5
®
Tubing clamp block RP 150 (included in RP 150, 10-80-00)
Tubing clamp inserts for tubing clamp block RP 150
1/4" x 1/16" red
1/4" x 3/32" yellow
5/16" x 1/16"
3/8" x 1/16" black
5/16" x 3/32"
3/8" x 3/32" blue
1/2" x 3/32" green
1/8" x 1/16" violet
3/16" x 1/16" mint-green
1/2" x 1/16" grey
Tubing clamp inserts for cardioplegia RP 150
3/16" x 1/16" light grey 1:1
3/16" x 1/16"
1/4" x 1/16" light brown 1:1
1/4" x 1/16"
3/16" x 1/16" white 2:1
1/8" x 1/16"
1/4" x 1/16" light blue 2:1
3/16" x 1/16"
1/4" x 1/16" turquoise 4:1
1/8" x 1/16"
17/64" x 1/16" brown 8:1
3/32" x 1/16"
Part numberProduct designation
10-81-35
10-64-15
10-64-25
10-64-40
10-64-50
10-64-65
10-64-05
10-64-10
10-64-55
10-64-70
10-64-71
10-64-72
10-64-74
10-64-76
10-64-78
Technical claims supported by LivaNova data on file
11
®
S5
TUBING CLAMPS
Variolock tubing clamp module
Self-locking mechanism keeps tubing in place
on the pump housing.
The Variolock tubing clamp module was developed for the heads
of roller pumps.
A large range of tubing clamp inserts for single and double
(e.g. for cardioplegia delivery) tubing configuration are available.
Part numberProduct d designation
Variolock tubing clamp module RP 150 (optional)
Tubing clamp inserts for Variolock
included (in 10-81-30) 1/4" x 1/16" red (small)
1/4" x 3/32"
5/16" x 1/16"
3/8" x 1/16"
5/16" x 3/32"
3/8" x 3/32"
3/8" x 3/32" blue (large)
1/2" x 1/16"
1/2" x 3/32"
Tubing clamp inserts for Variolock for cardioplegia
optional 1/4" x 1/16" 1:1
1/4" x 1/16"
1/4" x 1/16" 2:1
3/16" x 1/16"
1/4" x 1/16" 4:1
1/8" x 1/16"
Tubing clamp block DRP 85
Tubing clamp blocks that can take tubing sizes
up to 5/16“ x 1/16“ have been developed for
the small roller pump.
10-81-30
10-61-73
10-61-72
10-61-91
10-61-92
10-61-93
Tubing clamp block DRP 85 (included in DRP 85, 10-85-00)
included 1/4" x 1/16" red
1/4" x 3/32" yellow
5/16” x 3/32” black
optional 1/8" x 1/16" violet
3/16" x 1/16" mint-green
Technical claims supported by LivaNova data on file
12
Part numberProduct designation
10-86-56
10-86-57
10-86-58
10-86-55
10-86-59
SYSTEM PANEL
S5 system panel
S5 panels are configured according to
the customer's needs.
The S5 system panel contains
the display and control modules
for all of the monitoring, control
and measuring devices and is,
alongside the pump control panel,
another interface between the
operator and the S5 System. The
system panel can be mounted on the
left or right mast of the standard mast
system as required.
®
S5
The holder with ball joint can be
swivelled into any desired position.
System panels with 3 to 6 slots
accommodate the control and
monitoring modules. All display and
control modules can be replaced
during operation if a fault occurs. The
data is displayed unchanged on the
replacement module.
Technical claims supported by LivaNova data on file
13
Temperature 1
Temperature 2
0:00
75:55
35:05
ECC-Timer
25.4
°C
°C
0.0
0.0
°C
Temperature 4 Timer 1
5:00:00
®
S5
SYSTEM PANEL
S5 display and control module
All display and control modules are physically identical but each one is controlled by its own separate microprocessor.
Panel displays are fully inter-changeable.
Interchangeability of the control panel
displays during ECC allows an im-
mediate takeover of the dedicated
configuration.
Information on the panel displays is
retained even in case of replacement.
The high-contrast TFT display has a
restrained colour scheme. The display
layout is determined by the chosen
control and monitoring function. All
pump control and monitoring function
settings - with a few exceptions - are
entered using the control module
touch screens.
S5 system components
3-position S5 system panel for 3 display and control modules 28-95-03
4-position S5 system panel for 4 display and control modules 28-95-00
Part numberProduct designation
Touch screen display enables a fast
and easy panel navigation.
TIMERS
Three timers that work independently of each other can measure the duration of three simultaneous separate processes,
for example the complete bypass time or the aortic cross-clamping time.
The timers can be started and
stopped individually.
It is possible to carry out cumulative
measurements with each timer.
The measurement range for each timer
is 999 min 59 sec.
A fourth timer can (depending on
the setting) count upwards or down-
wards for a maximum of 10 hours or
600 minutes (optional, available on
request).
5-position S5 system panel for 5 display and control modules 28-95-01
6-position S5 system panel for 6 display and control modules 28-95-04
1 display and control module 28-95-10Z
Blank module 28-95-30
ECC-Timer
0:00
75:55
35:05
Timer 1
5:00:00
Technical claims supported by LivaNova data on file
14
S5
105
80
Pressure 1
Pressure 2
mmHg
mmHg
10.4
°C
Temperature 2
20.5
°C
Temperature 1
0:00
75:55
35:05
ECC-Timer
0:00
75:55
35:05
ECC-Timer
PRESSURE CONTROL
The Pressure Control Module measures and displays the pressure in the cardiopulmonary bypass circuit.
The Pressure Control Module controls perfusion with constant adjustable pressure (set value) through automatic variation
of the pump speed (control mode).
®
The Pressure Control Module limits
the pressure to values set by the clini-
cian by stopping the pump (monitoring
mode) when the preset pressure (stop
limit) has been reached.
The display range extends from -300
mmHg to +800 mmHg.
The values can be displayed in either
mmHg or kPa.
The Pressure Control Module allows
the operator to control two pumps
independently of one another.
Pressure 1
105
Pressure 2
80
mmHg
mmHg
Technical claims supported by LivaNova data on file
Part numberProduct designation
Sensor module 2-channel pressure monitor 22-20-20Z
Sensors and accessories (optional)
Medex transducer (MX 960)
Cable for Medex transducer
Holder for one Medex transducer
Holder for 2 Medex transducers
15
Part number
45-04-03
45-04-15
45-04-16
45-04-17
105
80
Pressure 1
Pressure 2
mmHg
mmHg
10.4
°C
Temperature 2
20.5
°C
Temperature 1
0:00
75:55
35:05
ECC-Timer
105
80
Pressure 1
Pressure 2
mmHg
mmHg
0:00
75:55
35:05
ECC-Timer
®
S5
TEMPERATURE MONITOR
The temperature monitor simultaneously measures and displays up to four temperatures.
One temperature sensor module
channel is reserved to cardioplegia
control.
An upper and a lower temperature
limit can be set. The values are set on
the control and display module on the
system panel. If the temperature limit
is reached, visual and acoustic alarms
are triggered.
Temperature 1
20.5
Temperature 2
°C
10.4
°C
Part numberProduct designation
Sensor module 4-channel temperature monitor 20-30-20Z
Part numberAccessories (optional)
Temperature probes for direct measurement
in the oxygenator (optional)
InspireTM temperature probe
Kids temperature probe
45-03-10
04222900
45-03-11
09026
Technical claims supported by LivaNova data on file
16
S5
Bubble Level
3/8"
1/2"
00:00
24.5
21
0.000 0.000
C
mmHg
l l
Cardioplegia
1/4"
LEVEL CONTROL
New Level Sensor technology continues to enable a fast response for patient safety and includes a new transparent
adhesive pad for a complete & clear blood level visibility.
A yellow line at the outside of the sen-
sor probe indicates the stop level and
triggers alarm or pump stop based on
the set up.
Level Sensor
Regulate and stop the arterial pump
flow when the blood level in the
reservoir reach the target volume.
Level Sensor Module
Fast recognition of the stop level in
the reservoir.
Design and performances in com-
pliance with latest EMC regulation.
Level
®
Level Sensor Pad
Easy to peel off protection foil
of the Adhesive tape of the Pad.
Symmetric pad to be mounted in
both directions for an easy pad
management.
Small and flexible pad to fit and
stick on every reservoir, including
the pediatric ones.
Transparent pad to offer a clear
view of the blood level.
Part numberProduct designation
S5 New level lensor module 23-41-00
23-41-51Adhesive level sensor pads 100 units
Technical claims supported by LivaNova data on file
17
®
Level
Bubble Level
3/8"
1/2"
00:00
24.5
21
0.000 0.000
C
mmHg
l l
Cardioplegia
1/4"
S5
BUBBLE DETECTOR
S5 allows optimized air management supported by a bubble sensor that can recognizes air bubble of different sizes.
This monitoring device detects air
bubbles in the extracorporeal circuit.
This function requires a sensor mod-
ule and the corresponding sensor. The
scope of delivery includes a bubble
detector that can be used for 3/8“
tubing. Alternatively, 1/2“ and 1/4“
sensors are available.
The 3-joint mast holder with a fast
clamp connector allows the bubble
sensor to be positioned at the tubing
system.
If air bubbles are detected, a visual
and acoustic alarm is triggered and
the connected pump stops.
Three different bubble detection
alarm thresholds can be set up (4 mm,
5 mm and 6.5 mm Ø).
Bubble
3/8"
1/2"
The bubble sensor positioned in the
arterial line 1 meter from the patient
allows effective and fast protection
from air bubbles.
The micro-bubble detection function
can also be activated.
Sensor module bubble detector consists of:
One bubble sensor 3/8“ (9.56 mm) (23-07-50)
and one 3-joint mast holder, 420 mm (23-26-96)
Sensor module bubble detector consists of:
One bubble sensor 1/4“ (6.35 mm) (23-07-40)
and one 3-joint mast holder, 420 mm (23-26-96)
Sensor module bubble detector consists of:
One bubble sensor 1/2“ (12.7 mm) (23-07-45)
and one 3-joint mast holder, 420 mm (23-26-96)
Sensor module bubble detector consists of:
One bubble sensor 3/8“ (9.56 mm) (23-07-50)
and one 3-joint mast holder, 620 mm (23-26-91)
Sensor module bubble detector consists of:
One bubble sensor 1/4“ (6.35 mm) (23-07-40)
and one 3-joint mast holder, 620 mm (23-26-91)
Sensor module bubble detector consists of:
One bubble sensor 1/2“ (12.7 mm) (23-07-45)
and one 3-joint mast holder, 620 mm (23-26-91)
Part numberProduct designation
23-45-00Z
23-45-01Z
23-45-02Z
23-45-10Z
23-45-11Z
23-45-12Z
Technical claims supported by LivaNova data on file
18
CARDIOPLEGIA CONTROL
Bubble Level
3/8"
1/2"
00:00
24.5
21
0.000 0.000
C
mmHg
l l
Cardioplegia
1/4"
Bubble Level
3/8"
1/2"
The Cardioplegia delivery system on the S5 offers a choice of different settings per cardioplegia technique.
This unit can be used with a RP 150
or a DRP 85 to deliver cardioplegic
solutions or blood cardioplegia during
an operation. The operator can
choose between two operating modes
that can be selected in the menu of
the control and display module.
Manual operation
The operator can start and stop
the pump. The dose volume to be
delivered counts up on the volume
display (beginning at 0).
Cardioplegia
0.000 0.000
l l
00:00
1/4"
24.5
21
S5
mmHg
C
®
Automatic operation
In this operational mode an exact
preset dose is delivered. In this case
the volume display starts at the preset
dose and counts down to 0. Then the
pump stops.
As soon as the sensor detects bubbles,
the cardioplegia pump stops automat-
ically and the cardioplegia delivery is
interrupted.
At the same time, the visual and acous-
tic alarms are triggered.
When the preset pressure (stop limit)
has been exceeded, the cardioplegia
pump stops and cardioplegia delivery
is interrupted. At the same time, the
visual and acoustic alarms are trig-
gered (monitoring mode).
The control mode can also be set.
The integrated timer automatically
starts during a pump stop regardless
of operational mode and records the
ischaemia time.
The (total) volume delivered since the
start of cardioplegia is accumulated
and displayed.
The cardioplegia sensor module has its
own connectors for a bubble sensor
and a pressure transducer.
Technical claims supported by LivaNova data on file
Part numberProduct designation
Sensor module cardioplegia control 27-80-20Z
Sensors and accessories (optional)
Medex transducer (MX 960)
Cable for Medex transducer
Holder for one Medex transducer
Holder for 2 Medex transducers
Part number
45-04-03
45-04-15
45-04-16
45-04-17
Bubble sensor
1/4“ (6.35 mm)
1/2“ (12.7 mm)
3/8“ (9.56 mm)
3-joint mast holder with fast clamp
connectors for 2 sensors, 620 mm
3-joint mast holder with fast clamp
connectors for 2 sensors, 420 mm
23-07-40
23-07-45
23-07-50
23-26-91
23-26-96
19
®
S5
B-CAPTA
B-Capta is fully integrated in the world leading S5 Heart-Lung Machine.
B-Capta provides an in-line continuous monitoring of the patient’s parameters during the entire duration of pediatric
and adult procedures and provides visual and audible indicators when parameters fall outside user-specified thresholds.
B-Capta is based on an accurate and reliable optical based technology improved to guarantee a high level of accuracy
and reliability when measuring the patient blood gas parameters, even in long and complex cardiopulmonary bypass
procedures.
Venous and Arterial Sensor
B-Capta includes a venous sensor and
an arterial sensor.
Both sensors must be used in
conjunction with a disposable cuvette
in the blood line for optical reading.
By means of their cables, they are
connected to the B-Capta sensor
module installed in the S5 HLM.
The venous and arterial sensors can be
identified by the blue (venous) or red
(arterial) marker on the housing. The
sensors are suitable for all available
cuvette sizes.
Sensor Module
The B-Capta sensor module is mounted
in the electronics and power pack
(E/P pack) of the S5.
The ports for the venous and the
arterial sensors are colour-coded.
The sensor module is the interface
between the sensors and the displet
on the S5 system panel and transfers
all measured values.
Blue connector = venous senor
Red connector = arterial sensor
Mast-mountable holders
with venous and arterial
reference element
B-Capta is equipped with two reference
elements respectively:
- one for the venous sensor
- one the arterial sensor
The reference elements are installed on
mast-mountable holders and consist of
a specific reference cuvette. Before the
actual measurement, the sensors are
subjected to a self-test by mounting
them onto the reference elements.
Technical claims supported by LivaNova data on file
20
B-CAPTA
S5
®
Disposable Venous and
Arterial cuvettes
The cuvettes are available in different
sizes for both venous and arterial lines.
The disposable cuvettes are available
as sterile stand-alone disposable and
may be supplied as preconnected or
non preconnected in the Perfusion
Tubing Sets (PTS).
The user interacts with the device through the display
of the S5 HLM
The Graphical User Interface supports the user to:
• Display values measured
by the sensors:
- Venous:
- Oxygen Saturation (Sat)
- Hematocrit (Hct) or
Hemoglobin (Hb)
- Temperature (venT)
- Arterial:
- Partial pressure of oxygen
ACT
(pO
2
- Temperature (artT)
• Select
the value to be shown
on the main display:
- Hct or Hb
ACT
2
or pO
- pO
• Change
measurement unit
(for Hb and pO
or pO
)
2
2
37°C
2
37°C
)
B-CAPTA Ven
Temp. venous
• Adjust the measured values
with laboratory values
(not applicable for the temperature)
• Set the warning limits
for each parameter:
These are intended to inform the
operator if the sensor is measuring
values outside the set thresholds.
B-CAPTA Art
O
2
53.0
27.7
28.1
Sat
%
Hct
%
O
°C
2
28.3
148
artT
°C
37°C
pO
2
mmHg
2
B-Capta article numbers – Equipment & Disposable
Sensor module
venous & arterial
Venous sensor
& ref. element
P/N 25-95-20 96-414-170 25-95-70 96-414-180 25-95-80
FULL SYSTEM
SYSTEM VENOUS ONLY
25-95-00 YES YES YES YES YES
25-95-05 YES YES YES / /
Part number Part numberVenous cuvettes Arterial cuvettes
1/2"
3/8"
1/4"
05184
05183
05182
Venous r e f.
element holder
3/8"
1/4"
Arterial sensor
& ref. element
Arterial ref.
element holder
05191
05190
Technical claims supported by LivaNova data on file
21
Heater / Cooler 3T
37.0
2 1
30.4
°C
40.0
32.5
°C
14.0
17
°C
Gas blender
Air+O2
l/min
1.8
CO2
l/min
FiO2
0.35 0.9
®
S5
ELECTRONIC GAS BLENDER
The electronic gas blender allows to set, monitor and display the gas flows required for extracorporeal circulation. The
preset values (i.e. the total flow including Air + O2, FiO2 and CO2) can be set independently and are displayed on both
the gas blender and the display and control panel.
In the Electronic Gas Blender, the
actual values and the set values are
continuously compared. Additional
ly, the actual value is measured by 2
independent sensors and an alarm is
triggered if a deviation between the 2
values is detected.
The remote control of the Electronic
Gas Blender on the display and control
module can be used to change the set
values for Air + O
gas flow to blood flow. The operator
is made aware of the actual values
exceeding or dropping below the set
values by acoustic and visual signals.
The electronic gas blender is avail able
in three different versions:
, FiO2 and CO2 from
2
-
Electronic gas blender (10 l/min)
for adult perfusion
Gas blender
Air+O2
1.8
FiO2
l/min
0.35 0.9
CO2
l/min
Electronic gas blender (5 l/min)
for paediatric perfusion
Electronic gas blender (2 l/min)
for infant/neonate perfusion
Part numberProduct designation
Electronic gas blender (10 l/min)
Electronic gas blender (5 l/min)
Electronic gas blender (2 l/min)
Standard holder
(straight, with fast clamp connector)
Accessories (optional)
Holder (U-shaped with plate, only compatible
with 4- and 5-position consoles)
25-28-67
25-28-68
25-28-69
55-91-50
Part number
25-40-70
Technical claims supported by LivaNova data on file
22
VENOUS LINE CLAMP
The venous line clamp has a mechanical remote control.
It has a lightweight design. If the clamp
head is fixed to another part of the
venous tubing system, it might well be
necessary to support the clamp head
with a joint holder.
The 1 m Bowden cable connects the
clamp head with the control unit
and transfers settings entered on
the control unit immediately to the
clamping lever in the clamp head.
The control unit is mounted on one
of the S5‘s push bars (right or left –
depending on the system arrangement
and/or ease of use). The coarse and
fine setting knobs are used for setting
the tubing diameter and regulating the
venous return flow quickly.
S5
®
Part numberProduct designation
Venous line clamp remote control 12-40-00
3-joint mast holder for venous line clamp
With fast clamp connector (586 mm)
With fast clamp connector (386 mm)
Tubing Inserts in sets with 4 pcs. each (incl.)
ø 1/4" x 1/16" red
ø 3/8" x 3/32" blue
ø 1/2" x 3/32" green
Tubing Inserts in sets with 4 pcs. each (opt.)
ø 1/4" x 3/32" yellow
ø 3/8" x 1/16" black
ø 1/2" x 1/16" grey
ø 5/8" x 3/32" brown
ø 1/8" x 1/16" violet
ø 3/16" x 1/16" turquoise
Part number
12-30-90
12-30-95
Part number
10-07-20
10-07-23
10-07-25
Part number
10-07-21
10-07-22
10-07-24
10-07-26
10-07-27
10-07-28
Technical claims supported by LivaNova data on file
23
Pressure 3
100
mmHg
120
mmHg
Pressure 1
120
mmHg
Pressure 2
Level
Bubble
3/8"
1/2"
Occluder 1
%F
0
100
1/2"
x
3/32"
Level
Bubble
3/8"
1/2"
®
S5
EVO - ELECTRICAL VENOUS OCCLUDER
The Electrical Venous Occluder (EVO) provides precise, controlled and ergonomic operation when initiating and ending CPB.
The EVO is able to apply an occlusion
of perfuson tubing that varies between
fully unoccluded to fully occluded.
When the pump is stopped manually,
EVO helps achieve controlled regula-
tion of the venous return flow.
The clamp closes automatically when
the stop link function to the arterial
pump is activated, if the latter has
been stopped by monitoring functions
in case of an alarm or is stopped
manually.
When the arterial pump starts up,
the EVO opens to the most recently
specified set value. An override of the
stop link function is possible at any
time, directly at the EVO operating
unit.
Use the relevant keys or the setting
knob on the EVO operating unit to
open and close. When the setting knob
is turned, there is audible clicking and
locking into place. Different ranges can
be selected for a fine adjustment.
The set value can be preset when the
occluder is closed and the stop link
function is activated.
Occluder 1
1/2"
x
3/32"
0
100
%F
Audible clicking and locking into place
make you doubly aware of setting knob
adjustments.
A choice of fine adjustment from < 40%
in 10% steps.
The stop link delay for a level alarm is
adjustable from 0 to 60 seconds.
Technical claims supported by LivaNova data on file
Electrical venous occluder
consists of:
Occluder (with mast holder)
Control unit
24
Part numberProduct designation
12-80-00Z
12-80-10Z
28-95-70Z
ACCESSORIES
S5
®
Colour coding set
To identify the role of each pump
according to customer
requirement.
Cable holders
To ensure the desired routing of cables
and tubing on the mast system. The
holders can be installed anywhere on
the mast system.
Available in sets of 6.
LED console lamp
Cover for fast clamp connectors
Perfusionist‘s chair
S5 adapter cable
To connect S5 accessories
(SCP, ERC, gas blender)
to the S5 System.
Writing desk DIN A4
Colour coding set
Cable holders / 6 clips Ø 33 mm mast diameter
Cable holders / 6 clips Ø 25 mm mast diameter
Perfusionist‘s chair
S3 to S5 adapter cable
LED console lamp
Cover for fast clamp connectors (set of 6 pieces)
Writing desk DIN A4
Part numberProduct designation
50-80-99
45-09-10
45-09-11
41-02-98
45-12-00
35-05-80
43-42-61
48-04-00
Technical claims supported by LivaNova data on file
25
®
S5
ACCESSORIES
S5 shelf
The shelf is available in three sizes (for
3-, 4- and 5-position pump tables). It
can be supplied with or without a AC
outlet strip.
S5 pump spacer
The S5 roller pumps for 3-, 4- and
5-position pump tables can be raised
by 10 cm using the pump spacer.
S5 plexiglas display protector
This cover protects the roller pump
displays against falling objects.
S5 shelf for roller pump 150
A stainless steel shelf for storing small
parts is available for every roller pump.
A longer version for 2 roller pumps is
also available.
Part numberProduct designation
3-position 4-position
5-position
Technical claims supported by LivaNova data on file
S5 shelf with AC outlet strip 48-31-19
S5 shelf without AC outlet strip 48-31-10
S5 pump spacer
S5 plexiglas display protector
48-31-20
48-31-30
S5 shelf for roller pump 150
S5 shelf for 2 roller pumps 150
26
48-41-19
48-41-10
48-41-20
48-41-30
all sizes: 10-84-60
all sizes: 10-84-64
48-51-19
48-51-10
48-51-20
48-51-30
ACCESSORIES
S5
S5 drawer module
The stainless steel drawer module
can be used for storing utensils. It
has a drawer on tracks with a stop
to prevent it from falling out. There
is an additional sliding tray inside the
drawer. The drawer module occupies
a single pump space on the console.
®
Product designation
S5 ice container
Infusion bags and bottles (for example
cardioplegic solutions) can be cooled
and stored in the S5 ice container.
It consists of an outside casing and
a stainless steel insert. The chilled
bottles etc. are always within reach if
the ice container is mounted on the
right or left push bar of the S5!
S5 tubing guide holder
Part number
Technical claims supported by LivaNova data on file
S5 drawer module 48-41-70
S5 tubing guide holder
incl. connectors and a 6-m length of PVC tubing
LED console lamp
Writing desk DIN A4
Cover for fast clamp connectors (set of 6 pieces)
16-05-60
35-05-80
48-04-00
43-42-61
27
Heater / Cooler 3T
37.0
2 1
30.4
°C
40.0
32.5
°C
14.0
17
°C
Gas blender
Air+O2
l/min
1.8
CO2
l/min
FiO2
0.35 0.9
Gas blender
Air+O2
l/min
1.8
CO2
l/min
FiO2
0.35 0.9
®
S5
HEATER-COOLER 3T
The Heater-Cooler System 3T / 3T plus
is intended to provide temperature-
controlled water to heat exchanger
devices (cardiopulmonary bypass
heat exchangers, cardioplegia heat
exchangers, and thermal regulating
blankets) to warm or cool a patient
during cardiopulmonary bypass
procedures.
The device has 3 separate water tanks
and 3 water circuits that can be used
simultaneously. Circuits 1 and 2 use an
identical preset temperature and are
mainly used to control the patient‘s
temperature.
Circuit 3, which has a separate
cold water and warm water tank, is
specially designed for cooling and
heating blood and/or cardioplegic
solutions. Cold water and warm
water tanks with the relevant preset
temperatures are available during
operation at all times.
Heater / Cooler 3T
37.0
40.0
14.0
°C
°C
°C
30.4
32.5
17
Separate cold and warm water tanks allow the operator to switch between
warm and cold cardioplegia spontaneously.
2 1
The patient and cardioplegia circuits
can be switched off separately
when not in use.
An independent safety system
stops the water temperature
reaching critical values.
The pump suction stage ensures
that the heat exchanger and
tubing are purged.
Heating-cooling blankets connec-
ted to the heater-cooler provide an
additional support for regulating the
patient‘s blood temperature.
The device is operated and monitored
from its own control panel or,
alternatively, from the display and
control modules on the system panel
(see illustration).
*The product may not be available in all countries. Make sure to choose the model that corresponds to your area's electricity voltage.
Technical claims supported by LivaNova data on file
Product designation
Part number
Heater-cooler 3T, 230 V* 16-02-80
Accessories (included)
Connection cable (6 m) between S5 and
Part number
45-12-16
Heater-Cooler 3T
Connectors
Part number
Hansen connector (female) for oxy straight 3/8" 73-300-089
Hansen connector (female) for oxy 90° 3/8" 73-300-090
Disposable
3T Aerosol Collection Set
¼” ID vacuum extension line with connector,
366 cm (12 ft)
Part number
050900100
050900111
Part number
28
S5
®
CONNECT
The LivaNova intuitive perfusion data management system designed to improve clinical efficiency and enable Goal-Directed
Perfusion Therapy.
®
Main Connect features:
Connect allows trending while centralizing all patient data on one
screen.
Connect permits automatic transfer of information from LivaNova
disposables and the creation of electronic patient records.
Provides customizable online quality indicators and post-op electronic
quality reports.
Connect enables Goal-Directed Perfusion (GDP) Therapy through
the monitoring of critical metabolic patient parameters with the
GDP Monitor.
Connect is an electronic charting system that allows continuous data recording and trends visualization aimed to support
clinicians and institutions in their perfusion management and documentation goals, before, during and after cardiac surgery.
Connect supports the Perfusionist during the entire Perfusion journey:
Prior to surgery, a case is created for each patient, either manually or automatically, through the hospital EMR system.
This import contains all relevant demographic and other surgery-related information.
During surgery, a 15” medical-grade computer, attached to the LivaNova Heart-Lung Machine (HLM) collects patient
data from the HLM and other external patient monitoring devices.
During the operation, the perfusionist can continuously view data and events as charts or tables,
according to the user preference.
The perfusionist may also enter data as well as comments and event entries in order
to have complete documentation of of the case.
Connect may also be configured to collect data electronically from a variety of
patient monitors, blood gas devices, ACT meters, cerebral oximetry devices, etc.
Post-operatively, the perfusionist can create a complete electronic medical
record of the patient, which can then be uploaded to various destinations,
such as patient’s EMR record.
• Minimize transcription errors, bias
and all the drawbacks associated
• Restrict Inefficiencies of manually
• Simplify data record analysis
The Connect
workflow system1:
with manual operations
entering product data
1. Ottens J, Baker RA, Newland RF, Mazzone A. The Future of the Perfusion Record: Automated Data Collection vs. Manual Recording. JECT 2005;37:355-359.
Technical claims supported by LivaNova data on file
29
S5
Jeffrey, Jameson
12/6/1958 (57 Years, 4 Months)
ECC No:
Admission No:
Case Number:
Patient Data
Gender:
Male
Transferred from:
Start of Surgery:
1:29 PM
Risk Score:3NYHA:
II-III
EF (ejection fraction) (%):
85
Allergies:
Infections:
Premedication:
Studies:
Surgery Team
Perfusionist
Perfusionist 1
Surgeon
Surgeon 1
Cardiologist
Cardiologist 1
Anesthetist
Anesthetist 1
OR nurse
OR nurse 1
Visiting surgeon
Visiting surgeon 1
Instrumentation
Autotransfusion:
Xtra
BGA Online:
CDI 100
BGA Offline:
Radiometer
ACT:
Gas Monitor:
Cerebral Oximeter:
Disposables
Type
Identification
Reference Number
LOT Number
Serial Number
Vendor
Expiry Date
Tubing Set
Blue Ribbon
Sorin
Reservoir
Avant
Sorin
Pre Bypass Filter
.2 Micron; ½ x ½
Sorin
Hemoconcentrator
DHF 0.2
Sorin
Cardioplegia Heat
Heat exchanger 1
Sorin
®
CONNECT
The Connect System consists of
®
Export from Manager
Import to Recorder
two core components:
The Connect Manager:
Create patient(s)
- Manages all case data in one central SQL database
- Provides retrospective data analysis with included
statistics tool
- Generates and exports electronic perfusion
case reports
- Allows full customization of the Connect Recorder
according to user preferences
- Can be installed on any hospital computer
Generate Repor t
(PDF)
Page:
Perfusion Record
Date of Surgery:
123-456
(m^2):
Nurse anesthetic Nurse anesthetic 1
2 Blood Type: A positive
PROSE (Prospective Randomized On-X / St. Jude Medical Evaluation)
3 / March 2016
OR:
printed at:3/31/2016
Hospital
Street
Town
Title: Maiden Name: End of Surgery: 5:34 PM
Physique
Height (cm): 180 Body Surface Area (BSA)
Weight (kg): 80 Calculated Flow (l/min): 4.8 Flow index (l/min/m^2): 2.4
Surgical Access: minimally invasive surgery Urgency: elective
Clinical Data
Procedures: Diagnoses: Risks:
cancer treatment product LH34
coumarin-based anticoagulant
Assistant Assistant 1
HLM: Sorin C5
Arterial Pump: CP5
Heater/Cooler: Sorin 3T
Patient Monitor: Philips
Oxygenator Apex HP Sorin
Exchanger
1
3/31/2016
1
Wi-FiUSB LAN
Complete Case
The Connect Recorder:
- Collects and visualizes data from the HLM and
Import to Manager
other external devices
- Offers a high level of customization to optimize
viewing preferences
- Offers quick single-touch event entries at any time
- Enables Goal-Directed Perfusion parameters
via the GDP Monitor
Connect
Manager
Case record
database
Database
query tools
Print or export
patient records
Connect
Recorder
Automatic case
information capture
Connect system setups may be tailored to suit hospital requirements. The LivaNova technical support team works together
with relevant hospital I.T. departments to identify the most appropriate Connect system setup.
Connect may be installed with a variety of connectivity options:
1. Basic, local installation
2. Full network installations with one Manager
3. Full network with multiple Manager installations
4. Direct network transfer between Manager and Recorder
5. HL7 integration with hospital EMR systems
S5
Database
query tools
Print or export
patient records
Customizable
data charts
Export from Recorder
Quick, easy manual
event entr y
CONNECTTM HL7
Connect with HL7 integration simplifies data exchange between the Connect components and the Hospital EMR System
(HIS). It is the keystone for the exchange, integration, sharing and retrieval of electronic health information.
The flexible and customizable optionally available HL7 interface is an integrate, bidirectional communication system
between Connect and the Electronic Medical Record (EMR). It allows the perfusionist to retrieve and share patient in-
1
formation from and to an EMR system to simplify workflow and improve clinical practice
Main clinical benefits of CONNECT HL7 interface/CONNECT HL7 interface1:
- Simplification of the clinical data workflow
- Improved data integrity
- Enhanced legibility
- Reduction in manual processes
Main features of CONNECT HL7 interface/CONNECT HL7 interface:
- New graphical user interface with a powerful HL7 search engine to search for patient data in the EMR system and
seamlessly import it into either Connect Manager or Connect Recorder
- Automatic upload of the post-operative PDF patient record into the EMR system
- Post-operative export of recorded patient data during Extra Corporeal Circulation (ECC) directly into the graphical
user interface of the EMR system
- Full customization options to reflect hospital specific EMR and emergency workflows.
1. Newland et al. Integration of Electronic Perfusion Data for Perfusion Registries. J Extra Corpor Technol. 2018;50:102–12.
.
Technical claims supported by LivaNova data on file
30
S5
®
CONNECT
®
Order Guide IDENTIFICATION
ITEM CODE IDENTIFICATION DESCRIPTION QUANTITY / BOX
24-90-80 Connect Recorder for S5 1
24-90-45 Connect Manager 1
Please contact your local Representative for more details.
ITEM CODE IDENTIFICATION
24-11-10 Connect HL7 Interface Package
24-11-20 Connect HL7 Datapoints
24-11-50 Connect HL7 1 Year Extension
24-11-60 Connect HL7 2 Years Extension
24-11-70 Connect HL7 3 Years Extension
24-11-80 Connect HL7 5 Years Extension
24-11-30
24-11-40
Additional Customization
and Services (10h)
Additional Customization
and Services (20h)
SPECIFICATIONS:
Connect Manager
Operating system: Microsoft
Database: Microsoft
®
DataPad for Connect Recorder
Operating system: Windows 10 Enterprise LTSC 2018 64-bit
®
CPU: Intel
Celeron® 2002E 1.5GHz
RAM: 4GB DDR3L 1600
1x COM Port RS232
4x USB Port (2.0, EHCI)
1x DVI Port
1x IEEE 802.3u 100 Base-Tx Fast Ethernet compatible port
HDD: 64GB SSD
Removable HDD: 16GB CFAST
Database: Microsoft
15” Resistive touch screen
®
WLAN Module Specifications
Frequency Range: 2.4 GHz to 5 GHz
Wireless network standard: IEEE 802.11a/b/g/n
®
Windows 10, commercial versions
SQL Server 2017.
SQL Express 2017
Technical claims supported by LivaNova data on file
31
®
S5
1.0 DIMENSIONS, WEIGHTS, OPERATING CONDITIONS
TECHNICAL SPECIFICATIONS
1.1 CONSOLE
Height (to the surface of the pump cover) 640 mm
Depth 600 mm
Console 3-position 4-position 5-position
Width (incl. push bars) 745 mm 890 mm 1073 mm
Weight 83.4 kg 86.3 kg 89.5 kg
Operating conditions
Operating temperature + 10 °C ... + 40 °C
Storage temperature 0 °C ... + 40 °C
Relative humidity (operating and storing)
30% ... 75%
1.2 MASTS
Maximum permissible load Mast system extension (optional)
Maximum total load on mast system 45 kg Maximum load on the telescope mast 40 kg
Maximum load on a mast 20 kg
(1)
Maximum load on the vertical mast 11.5 kg
1.3 PUMPS
Roller pump 150
Double roller
pump 85
Height 285 mm 257 mm 289 mm 237 mm 237 mm
Width 180 mm 180 mm 178 mm 116 mm 260 mm
Depth 485 mm 485 mm 299 mm 175 mm
Weight 15 kg 12 kg 11.9 kg
Pump specifications Roller pump Double roller pump
Diameter of pump raceway Ø 150 mm 85 mm
Diameter of occlusion roller Ø 30.5 mm 15 mm
Speed range 0 to 250 rpm (clockwise, counterclockwise)
Deviation in speed accuracy ±1% of the terminal value 250 rpm plus ±0.5% of set value
during continuous operation:
Speed deviation in the event of a fault
(Detection of faulty speed from 30 rpm)
Direction of rotation Clockwise/counterclockwise Clockwise/counterclockwise
+15% max.; 2 revolutions max. until pump stops
Mast roller
pump 150
(2)
5 kg
Mast roller
pump 85
(3)
200 mm
(2)
11 kg
2 mast roller
pumps 85
(5)
(4)
Concentricity
Pump raceway
Occlusion symmetry
Occlusion rollers
(1)
max. swivel arm 200 mm;
(4)
with double holder;
Technical claims supported by LivaNova data on file
(2)
with fast clamp connector;
(5)
without double holder
0.03 mm
0.03 mm
0.015 mm
(3)
without fast clamp connector;
32
0.03 mm
0.03 mm
0.015 mm
TECHNICAL SPECIFICATIONS
1.3 PUMPS
Displays Roller pump Double roller pump
rpm display range 0 to 250 rpm 0 to 250 rpm
Resolution 1 rpm 1 rpm
l/min display range (flow)
1/8“
3/16“
1/4“
5/16“
3/8“
1/2“
Deviation of speed slave pump max. 1 percentage point of the flow ratio setting
Power supply Roller pump Double roller pump
Operating voltage 24 V DC 24 V DC
Power consumption 160 W 160 W
0 to 0.83 l/min
0 to 1.79 l/min
0 to 3.12 l/min
0 to 4.70 l/min
0 to 6.50 l/min
0 to 11.2 l/min
0 to 0.44 l/min
0 to 0.93 l/min
0 to 1.57 l/min
0 to 2.33 l/min
0
0
®
S5
1.4 SYSTEM PANEL
For 3 display and
control modules
Height 475 mm 590 mm 723 mm 475 mm
Width 184 mm 184 mm 184 mm 375 mm
Depth (without mast holder) 94 mm 94 mm 94 mm 94 mm
Weight (without display and control module) 3.9 kg 4.5 kg 5.1 kg 7 kg
Display and control module Control module for mast roller pumps
Height 125 mm 260 mm
Width 179 mm 190 mm
Depth 4 8 mm 100 mm
Weight 0.5 kg 3.5 kg
For 4 display and
control modules
For 5 display and
control modules
For 6 display and
control modules
(6)
2. ELECTRICAL SPECIFICATIONS
2.1 ELECTRONICS AND POWER PACK
Input voltages 100 V ~ bis 240 V~; 50 / 60 Hz
Permissible mains voltage fluctuation ± 10%
Maximum power consumption (standard equipment) 1000 W
(6)
with holder
Technical claims supported by LivaNova data on file
33
®
S5
TECHNICAL SPECIFICATIONS
2.2 UPS and Batteries
Operating time of UPS
At 400 W output power 20 minutes
At 160 W output power 90 minutes
Charging time 12-15 hours
2.3 System Panel
Display and control module / touch screen
Operating voltage 24 V
Power consumption 45 W
Pixel Failure Class Conformity with Pixel Failure Class III
2.4 Shelf with AC Outlet
3-/4-/5-position
Weight – shelf approx. 6.5 kg
Maximum load – shelf 8 kg
Number of sockets 4
Protection
Load rating 2 A maximum in total
Sum of leakage currents 500 μA max. in total
Level
Alarm limit (level sensor) for oxygenators/reservoirs made
of rigid polycarbonate, wall thickness at sensor position
3 mm max.
Pressure
Measurement range mmHg -200 mmHg to +800
Resolution 1 mmHg
Cardioplegia
Pressure measurement range -200 mmHg to +800 mmHg
Resolution 1 mmHg
at 230/240 V: Circuit breaker 1 A
at 110/115 V: Circuit breaker 2 A
Level display of the sensor holder ±10 mm
Temperature monitor
Display range 0 °C to +50 °C
Timer
Counting range 0 - 999 min 59 sec
Timer (optional)
Counting range 0 - 10 h (up and down)
Technical claims supported by LivaNova data on file
34
TECHNICAL SPECIFICATIONS
2.5 Modules and Sensors
Level sensor module
Alarm limit (level sensor) for oxygenators/reservoirs made
of rigid polycarbonate, wall thickness at sensor position
3 mm max.
Sensor module for bubble detector
Alarm limit (bubble sensor) at ≥ 15 rpm
1/2“ and 3/8“
Sensor module 2 channel pressure monitor
Accuracy ± 5 mmHg
Zero point adjustment range ± 100 mmHg
Gain adjustment range (matching) ± 20%
Input resistance 100 k
Output voltage to pressure transducer < 10 V
Level display of the sensor holder ±10 mm
Air volume: 0.144 cm3 (Ø 6.5 mm)
Air volume: 0.065 cm3 (Ø 5.0 mm)
Air volume: 0.034 cm3 (Ø 4.0 mm)
Ω
S5
®
Cardioplegia sensor module
Volume control
Setting range
Accuracy of dosage
Pressure monitor See sensor module 2 channel pressure monitor
Bubble detector See alarm limit of the bubble sensor
Sensor module 4 channel temperature monitor
Temperature measurement range 0 °C to +50 °C
Resolution 0.1 °C
Accuracy (without sensors) 0.0 °C - 25.0 °C ± 0.2 °C
0 to 2 liter
± 10%, min. ± 20 ml
25.0 °C - 45.0 °C ± 0.1 °C
45.0 °C - 50.0 °C ± 0.2 °C
Technical claims supported by LivaNova data on file
35
LivaNova Deutschland Quality System complies with:
EN ISO 13485:2012
According to Annex || (Full Quality Sytem) of
MDD 93/42/EEC as amended by directive 2007/47/EEC
Manufacturer:
Sorin Group Italia S.r.l.
A wholly-owned subsidiar y of LivaNova PLC
Via Statale 12 Nord, 86
41037 Mirandola (MO) Italia
Tel.: +39.0535.29811 - Fax: +39 0535 25229
Manufacturer:
LivaNova Deutschland GmbH
Lindbergstrasse 25
D-80939 München Germany
Tel: +49.(0)89.32301.0
Fax: +49.(0)89.32301.555
info.cardiacsurgery@livanova.com
For professional use. Please contact us through our website to receive instructions for use containing full prescribing information, including indications, contraindications, warnings, precautions
and adverse events. Not approved in all geographies. Consult your labeling.
© 2020 LivaNova all rights reserved.
11/20 IM-7300030-CP_B 09295-212
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