extracorporeal life support

pls sYSTEM

PLS Set and ROTAFLOW Console
A THERAPY OPTION FOR CRITICALLY ILL PATIENTS
MAQUET – THE GOLD STANDARD
MAQUET Cardiovascular is a leader in providing innova-
tive products for cardiac surgery, vascular interventions
and cardiac and respiratory support to hospitals and clinics
and the cardiac surgeons, interventional cardiologists,
­p erfusionists and other healthcare professionals who care
for patients with cardiovascular disease.
MAQUET Cardiovascular is focused on providing
­c linicians with future-oriented technology that fits into
their daily prac­t ice and that improves the therapeutic
­management of patients. MAQUET Cardiovascular continues
to invest in the development of innovative technologies
and solutions that advance clinical practice, improve patient
outcomes and enhance quality of life.
| The Gold Standard | Cardiovascular | PLS System | 3 |
The extremely demanding requirements for prolonged
life support call for technology with outstanding features.
The Permanent Life Support (PLS) System from MAQUET
has been developed to support patients requiring prolonged
respiratory and/or circulatory assistance with blood flows
between 0.5 up to 7 l/min.
ECLS (Extracorporeal Life Support) with MAQUET’s
PLS System offers:
  L ess damage to blood components1,2 – no unnecessary
parts and pieces that could obstruct the blood flow
  L ower risk of hemolysis and inflammation 3 – may help
­reduce costs
MAQUET – The Gold Standard.
| 4 | PLS System – Areas of Application | Cardiovascular |

permanent life support system

AREAS OF APPLICATION

The PLS System is an adult respiratory and/or circula-

tory support system for use in the intensive care unit,
­c ardiac catheter laboratory as well as operating, trauma  4
and emergency rooms validated with a CE certification for
14 days continuous use.* It can also be used to maintain
­extracorporeal support of patients being transported between
hospital departments 3.

In the intensive care unit the PLS System can provide

­a ppropriate short and long-term extracorporeal support 5
to adult patients with a wide range of life threatening
­c onditions. These may include:
  Acute Respiratory Distress Syndrome (ARDS) 3,4,5,6
  Pulmonary Embolism 3
  Septic Shock Syndrome 4
  Multiple Organ System Failure 4

In the catheter laboratory and cardiology department
the PLS System can be used to provide urgent circulatory
support with oxygenation in the event of sudden heart failure
thus preventing organ damage . Areas of application may
 2
include:
  Cardiogenic shock  2,4,6
  A s stand-by or prophylactic support during high-risk PCI
  Cardiopulmonary assist after right heart infarction  6
  A s a bridging system 6 (bridge to recovery, bridge to bridge,
bridge to decision), e.g. to treat myocarditis
Emergency medical situations can benefit from the
availability and mobility of the PLS System. Certain patients
can benefit from the rapid restoration and stabilization of
cardiopulmonary functions that ECLS can offer. The follow-
ing indications may be appropriate for using the PLS Sys-
tem:
  Anaphylactic shock 4
  Intoxication 6 
  Severe hypothermia 4
  Barotrauma 5,6

In the operating room patients who need post-surgery

»
­c irculatory support can be transferred onto the PLS System
PLS has made priming easier in reducing
«
and moved to the intensive care unit easily 3. Also patients
from the emergency and trauma rooms who need treatment the volume, plus it is inexpensive. 
in other hospital departments, e.g. for revascularization or
Hasse Karlsson
PTCA, can be placed on the PLS System and then moved to Per fusionist, Sahlgrenska University Hospital, Gothenburg, Sweden
the operating room, catheter laboratory or intensive care
unit. Areas of application may include:
  Cardiogenic shock 2,4,6
  Low cardiac output syndrome (LCOS) 6
  Bridge to recovery, bridge to bridge, bridge to decision 6
 | Cardiovascular | PLS System – References | 5 |

Knowledge database
References

References:
1 Bennett M. et al. Pump-induced haemolysis: a compari- 6 Puehler T. et al. Extracorporeal membrane oxygenation.
son of short-term ventricular assist devices. Perfusion Old instrument with a new look? Z Herz-ThoraxGefäßchir
2004; Vol. 19; (2): 107 – 111. (4) 2011; 25: 209-216
2 Yu K. et al. Clinical Evaluation of Two Different Extra­
corporeal Membrane Oxygenation Systems: A Single
Center Report. Artif. Organs 2011; Vol. 35; (7): 736.
3 Schmid C. et al. Venovenous extracorporeal membrane
oxygenation for acute lung failure in adults. The journal
of Heart and Lung Transplantation 2011; 31 (1): 9 – 15.
4 Arlt M. et al. Extracorporeal membrane oxygenation in
»As the numbers on the waiting lists for
lung transplantation are steadily increasing,
severe trauma patients with bleeding shock. Resuscita- along with the waiting time, mechanical
tion 2010; 81 (7): 804 – 809 lung support by ECMO or artificial lung may
become important tools in the near future
«
5 Thiara APS. et al. Extracorporeal membrane oxygenation
support for 59 days without changing the ECMO circuit: to keep the respective patients alive.
a case of Legionella pneumonia. Perfusion 2009; Vol. 24;
Schmid C. et al.
(1): 45 – 47 The Journal of Hear t and Lung Transplantation, 2011; 31 (1): 14
| 6 | PLS System – Components | Cardiovascular |

THE PLS SYSTEM

COMPONENTS AT A GLANCE

The PLS System consists of the following components:

  PLS Set / PLS Set Plus or HIT Set PLS / HIT Set PLS Plus
  ROTAFLOW Console with ICU Kit RFC
  ROTAFLOW Drive Unit
  ROTAFLOW Emergency Drive
  Holder
  HLS Cannulae

The PLS Set consists of the PLS-i Oxygenator and the

ROTAFLOW Centrifugal Pump both incorporated in a tip-
to-tip BIOLINE coated tubing set. The high performance of
the oxygenator and pump ensures safe and effective patient
support and user management. The low resistance of the
PLS-i Oxygenator and the high efficiency of the ROTAFLOW PLS Set
Centrifugal Pump reduce blood damage to a minimum 2.

The PLS-i Oxy­g enator incorporates highly plasma re- The PLS Set Plus includes two additional connectors
sistant poly­m e­t hylpen­t ene (PMP) fibers with a modified with luer lock for hemofiltration or dialysis. The connectors
housing designed specifically for prolonged use. These tight have been incorporated between the oxygenator outlet
PMP fibers eliminate plasma leaks 2 and effec­tively prevent and pump inlet so that a CRRT device can be hooked up to
the formation of microbubbles. With an approval of 14 days the extracorporeal circuit.
continuous use, the need for oxygenator replacement is
­s ignificantly reduced 2.
HIT Set PLS and HIT Set PLS Plus are specially designed
for use on patients who are susceptible to heparin-induced
The ROTAFLOW Centrifugal pump with its high biocom- thrombocytopenia. In combination with SOFTLINE coated
patibility is responsible for improved blood handling and HLS cannulae, there is an approval for 5 days.
lower levels of pump-induced hemolysis 1,2. This centrifugal
blood pump without any shaft or seals has a spinning rotor
with flow channels that move the incoming blood in rotary
motion, directing it through a spiral housing to the outflow
port. The one-point sapphire bearing and the low priming
volume combined with the spiral formed chamber ensures
gentle blood handling 1,2 and op­ti­m ized blood flow.

peripheral HLS cannulae
SAFEGUARD POST-HEMOSTASIS MANAGEMENT
HLS Cannulae
The HLS Cannulae from MAQUET connect the PLS Set
to the patient’s blood vessels. These specially developed
cannulae can be safely and gently inserted into the veins
and arteries – either percutaneously or by surgical cut-down.
HLS Cannulae are made of biocom­p atible polyurethane
and, like all other blood-carrying components of the PLS
Set, BIOLINE coated. Their thin walls ensure excellent flow
with minimal pressure drop. In order to guarantee a high
­d e­g ree of flexibility and kink resistance particularly in long-
term use, all cannulae are wire reinforced.
The HLS Cannulae are available in several outside
­diameters (from 13 to 29 Fr.) and lengths (from 15 to 55 cm),
­a llowing an individual selection based on the patient’s
needs. When used with a PLS Set from MAQUET, the HLS
Cannulae are designed for 14 days continuous use.
MAQUET provides two special insertion kits for par­t i­
cularly gentle percutaneous vascular access. These
kits are fitted with guide wires of different lengths and fulfill
the requirements of arterial and venous cannu­lation. Further
components of the insertion kits are multi-step dilators in four
different sizes, a puncture needle, a scalpel and a syringe.
This ensures that everything is at hand in emergencies.
| Cardiovascular | PLS System – Cannulae & Accessories | 7 |
SAFEGUARD Pressure Assisted Device 24 cm
SAFEGUARD 24 cm is a versatile access site manage-
ment device that can be used following cannulation of the
femoral artery. SAFEGUARD’s hand-free pressure simplifies
post-hemostasis management of access sites. SAFEGUARD
facilitates site assessment through the clear window without
removing the device. It is a sterile dressing and can be used
to protect the site from contamination.
SAFEGUARD Pressure Assisted Device 24 cm
  D elivers adjustable post-hemostasis compression and
enables immediate pressure adjustment
 Maintains consistent pressure on the site during patient
recovery as well as patient positioning and transport
  Facilitates site assessment through the clear window
  Is comfortable for the patient
  Adheres to the patient while inflated regardless of
patient’s anatomy
SAFEGUARD 24 cm reduces demands on the staff, maxi-
mizes valuable resources, and enhances patient comfort.
| 8 | PLS System – Hardware | Cardiovascular |

Fully equipped SPRINTER CART XL

Hardware At a Glance

Infusion pole

ROTAFLOW Emergency Drive

ROTAFLOW Console

Fixed tray for

additional storage

Gas bottle with holder

EGB 40
Electronic Gas Blender

ROTAFLOW Drive Unit

HU 35 Heater Unit

Medical isolating
transformer
 | Cardiovascular | PLS System – Hardware | 9 |

The PLS System

Hardware Overview

The ROTAFLOW Console with the appropriate Emer-
gency Drive and the integrated Flow Bubble Sensor
provides consistent monitoring of the blood flow and guar-
antees air bubble detection at an early stage. The device
operates independently as a stand-alone console with its
own battery back-up and power supply. A battery capacity
of 90 minutes makes intra-hospital patient transport safe
and easy. Its compact design includes a display for all vital
information, at a glance.
The Medical Isolating Transformer offers highest possible
electrical safety for the connection of up to nine medical
devices. The Transformer Kit is available in two versions
with different power supplies: 230 V and 115 V. For further
electrical safety, both workstations have an equipotential
bonding pin.

The EGB 40 Electronic Gas Blender supplies the neces-

sary gas flow and the required concentration of oxygen for
the extracorporeal gas exchange. The EGB 40 is a stand-
alone device with an integrated battery back-up. The device
is intended for therapeutic and surgical use to accurately
mix oxygen with air.

The HU 35 Heater Unit supplies temperature controlled

water to the oxygenator allowing the temperature in the
extracorporeal circuit to be maintained between 33 and 39° C.

The stable and compact SPRINTER CART and its bigger

version, the SPRINTER CART XL, have been developed
as workstations for prolonged extracorporeal support appli-
cations for use in the operating room and intensive care
unit as well as for patient transport – especially in areas of
limited space. In these situations reliable and safe transport
solutions must be available.

The SPRINTER CART XL is also equipped with a top shelf

designed to accommodate the ROTAFLOW Console, but
at the same time offers more valuable space for additonal
devices.
| 10 | PLS System – Technical Data and Ordering Information | Cardiovascular |

Technical Data and ORDERING INFORMATION

PLS System and HLS cannulae

Technical Data

PLS Set
Total priming volume 585 ml
Blood flow rate 0.5 – 7 l/min

PLS-i Oxygenator
Gas exchange surface area 1.8 m²
Heat exchange surface area 0.4 m²
Water connectors 1/2" Hansen coupling
Housing material Polycarbonate (PC)
Fiber material for gas exchange Polymethylpentene (PMP)
Fiber material for water flow Polyurethane ( TPU)

ROTAFLOW Centrifugal Pump

Surface 190 cm²
Housing material Polycarbonate (PC)

ROTAFLOW Console
RPM speed 0 – 5000 RPM
Resolution of display 0.01 l/min
Flow rate 0 – 9.9 l/min
Dimensions 180 x 380 x 240mm
Weight Approx. 15 kg

Ordering Information

PLS Sets & Holder Code Order No.

Permanent Life Support Set BE-PLS 2050 70102.7818
HIT Set Permanent Life Support BO-PLS 2050 70105.0313
Permanent Life Support Set Plus BE-PLS 2051 70105.0310
HIT Set Permanent Life Support Plus BO-PLS 2051 70105.0311
Holder for PLS-i Oxygenator (rotary) HKH 7900 70103.1554

Ar terial HLS Cannulae Shor t Code Order No. Ar terial HLS Cannulae Long Code Order No.
Sizes from 13 Fr. to 23 Fr. BE-PAS 1315 70105.3276 Sizes from 15 Fr. to 23 Fr.
BE-PAS 1515 70104.7280 BE-PAL 1523 70104.7285
BE-PAS 1715 70104.7281 BE-PAL 1723 70104.7286
BE-PAS 1915 70104.7282 BE-PAL 1923 70104.7287
BE-PAS 2115 70104.7283 BE-PAL 2123 70104.7288
BE-PAS 2315 70104.7284 BE-PAL 2323 70104.7289

Venous HLS Cannulae Shor t Code Order No. Venous HLS Cannulae Long Code Order No.
Sizes from 19 Fr. to 25 Fr. BE-PVS 1938 70104.7290 Sizes from 21 Fr. to 29 Fr. BE-PVL 2155 70104.7294
BE-PVS 2138 70104.7291 BE-PVL 2355 70104.7295
BE-PVS 2338 70104.7292 BE-PVL 2555 70104.7296
BE-PVS 2538 70104.7293 BE-PVL 2955 70104.7297

Percutaneous Inser tion Kit Code Order No. Percutaneous Inser tion Kit Code Order No.
for ART. HLS CANNUL AE, 100 cm PIK 100 70104.7384 for VEN. HLS CANNUL AE, 150 cm PIK 150 10104.7385
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