ALUNG HEMOLUNG RAS Installation guide

Training Workbook
HEMOLUNG
RAS
®
Pioneered by
80400
HL-PL-0036_RH

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Table of Contents
1 Introduction ...................................................................................3
2 Theory of Operation.....................................................................4
3 Hemolung RAS Components .....................................................6
4 Preparation of the Hemolung RAS .......................................... 12
Part 1 Circuit Priming............................................................ 13
Part 2 Catheter Insertion .....................................................36
Part 3 Connect Tubing to Catheter.................................. 44
Part 4 Start Blood Pump......................................................45
5 Managing Therapy and Using the RAS .................................. 46
Controlling Pump Speed.................................................... 46
Controlling Sweep Gas Flow ..............................................47
Menu Screens ........................................................................47
Daily Vacuum Canister Replacement .............................. 49
Change Sweep Gas.............................................................. 50
Change Seal Flush Fluid...................................................... 50
6 Weaning & Ending Therapy....................................................... 51
Blood Rinse Back .................................................................. 51
Without Blood Rinse Back...................................................55
7 Troubleshooting ..........................................................................56
Management of Alarms .......................................................56
Critical Errors and Accidental Termination of Therapy .......57
8 Device Maintenance...................................................................59
Battery .....................................................................................59
Cleaning..................................................................................59
Storage ................................................................................... 60
Preventative Maintenance.................................................. 60
Contact Information............................................................ 60

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1 Introduction
The Hemolung Respiratory Assist System (RAS) is an integrated,
single-use gas exchange system designed to provide partial
extracorporeal respiratory support. Oxygen is supplied and
carbon dioxide is removed from blood circulated through the
Hemolung RAS. The utilization period of this device is validated
for up to seven days.
The intended users of the system are advanced health care
providers with experience in critical care hospital settings,
including registered nurses and physicians.
The Hemolung RAS Training Workbook contains extracts from
the Instruction for Use (IFU).
The Training Workbook is a training support tool that does not
contain safety and warning advice. It is intended as a quick
reference guide and does not replace clinical training for the
Hemolung RAS. The Workbook is not intended to be exhaustive.
In case of doubt the legal reference is always the Instruction for
Use.

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2 Theory of Operation
The Hemolung RAS is an integrated, single-use gas exchange
system that provides partial extracorporeal respiratory support
by providing gas exchange independently of the lungs. Oxygen
is supplied and carbon dioxide is removed from blood circulated
through the system. This gives the patient’s lungs time to rest
and heal.
Control of CO2removal is dependent on three fundamental
factors. These are:
• Patient pCO2
• Sweep Gas Flow Rate
• Blood Flow Rate (determined by motor RPM)
CO2removal is achieved by running the selected sweep gas
(oxygen or room air) through the center of the hollow fibers in
the Cartridge while blood is circulated around the outside of the
fibers. The sweep gas flow is determined by the programmed
Sweep Gas Flow Rate and the Blood Flow Rate is determined by
the pump speed.
The dierence in CO2concentration between the patient’s
blood (high) and the sweep gas (low) causes CO2to diuse
from the blood, across the membrane, and into the sweep gas.
The CO2is then exhausted from the Hemolung Cartridge.

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CO2OUT
O2
IN
BLOOD INLET
BLOOD OUTLE
T
GAS EXCHANGE MEMBRANE
SWEEP GAS OUTLET
SWEEP GAS INLET
INTE
G
RATED
C
ENTRIF
UG
AL P
U
MP
Microscopic View
of a Fiber
O2
CO2
BLOOD
Microscopic
View of a Fiber

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3 Hemolung RAS Components
The Hemolung RAS is comprised of 3 main components.
Hemolung Cartridge
• Membrane oxygenator with
integrated centrifugal pump
Hemolung Catheter
• 15.5 Fr dual lumen venous
Catheter with insertion
accessories, percutaneous,
single-stick venous access,
femoral (26cm) and jugular
(17cm) available
Hemolung Controller
• Controls the Cartridge pump speed
and gas flow while providing real-
time monitoring of CO
2
removal and
blood flow, bubble detection and
other operating alarms
• Infusion pump: continuous saline
infusion to prevent bearing damage
Always check the expiration date prior to use. Do not use
the disposable if it is expired.
See Section 2 in the Instructions for Use for more Detail.

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Cartridge
Catheters
Blood Inlet (BLUE)
Blood Outlet (RED)
Sweep
Gas Inlet
Seal Flush
Port with
OneWay
Valve
Sweep Gas
Outlet
Stylet
Drainage
Port
Infusion
Port
Infusion Lumen (RED)
Drainage Lumen (BLUE)
Infusion
Port
Drainage
Port
Drainage Lumen (BLUE)
Infusion Lumen (RED)
Suture Groove
Suture Groove

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Hemolung Cartridge Kit Contents
Product Description
Hemolung Cartridge Kit - SM IV Pump Configuration
Contains all subsequent equipment used to set up therapy
Hemolung Cartridge Kit - CME IV Pump Configuration
Contains all subsequent equipment used to set up therapy
Hemolung Cartridge
Membrane oxygenator with integrated centrifugal pump
Hemolung Accessories Kit - SM IV
Contains the following equipment to set up or stop therapy:
Hemolung Rinse Back Kit
Soda Lime Column
SM IV Administration Sets
Vaseline Jelly
(7) 1500 mL Vacuum Canisters
Hemolung Accessories Kit - CME IV
Contains the following equipment to set up or stop therapy:
Hemolung Rinse Back Kit
Soda Lime Column
IV Administration Sets
Vaseline Jelly
(7) 1500 mL Vacuum Canisters
Hemolung Cartridge Kit IFU
Printed Instructions for Use

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Hemolung Catheter Kit Contents
Product Description
Hemolung 15.5 Fr Femoral Catheter Kit
(1) 15.5 Fr Femoral Catheter with Stylet
(2) Grip-Lok™ Wide Adhesive Universal Catheter Securement
(5) 6, 9, 12, 14, & 16 Fr Dilator (1 of each)
(1) 10 mL Syringe
(1) #11 Scalpel
(1) 18 Ga x 7 cm (2.75 in) Introducer Needle
(1) 0.038 in x 100 cm Guidewire with Straightener and J-Tip
Hemolung 15.5 Fr Jugular Catheter Kit
(1) 15.5 Fr Jugular Catheter with Stylet
(2) Grip-Lok™ Wide Adhesive Universal Catheter Securement
(5) 6, 9, 12, 14, & 16 Fr Dilator (1 of each)
(1) 10 mL Syringe
(1) #11 Scalpel
(1) 18 Ga x 7 cm (2.75 in) Introducer Needle
(1) 0.038 in x 100 cm Guidewire with Straightener and J-Tip
Hemolung Controller
Product Description
Hemolung Controller
The reusable part of the Hemolung RAS. This self-contained unit
holds all electronics and monitoring sensors.

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Vacuum
Canister
Bracket
Diagnostic
Port
Display
Port
Controller
Power
Switch
AC Power
Inlet
Grounding
Port
Soda Lime
Column
Sweep Gas Port to
Hemolung Cartridge
Vacuum
Canister Port
O2Inlet Port
Purge Valve
Blood Flow Sensor
Bubble Detector
Magnetic
Drive
Audible
Alarm Key
Pump
Start/Stop
Key
Alarm LED
AC Power
LED
Arrow Keys
Function Keys
Controller
Hemolung Controller Display