ALUNG Hemolung CR4 Installation guide

Training Workbook
Pioneered by
80450
HL-PL-0256_RB

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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 .......................................... 15
Part 1 Circuit Priming............................................................16
Part 2 Catheter Insertion .....................................................27
Part 3 Connect Tubing to Catheter...................................35
Part 4 Final Checklist............................................................37
Part 5 Start Blood Pump ......................................................38
5 Managing Therapy and Using the RAS ...................................39
Controlling Pump Speed.................................................... 40
Controlling Sweep Gas Flow ..............................................41
Start/Stop Blood Pump........................................................42
Therapy Screen......................................................................43
Menu Screens ....................................................................... 44
Daily Vacuum Canister Replacement .............................. 46
Change Seal Flush Fluid.......................................................47
Clean Magnetic Fan Cover..................................................47
6 Weaning & Ending Therapy...................................................... 48
Blood Rinse Back ................................................................. 48
Without Blood Rinse Back...................................................52
7 Troubleshooting ..........................................................................53
Management of Alarms .......................................................53
Critical Errors and Accidental Termination of Therapy .......54
8 Device Maintenance...................................................................56
Battery .....................................................................................56
Cleaning..................................................................................56
Storage ....................................................................................57
Preventative Maintenance...................................................57
Contact Information.............................................................57

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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
Ref Product Description
13000 Hemolung Cartridge Kit - CME IV Pump Configuration
Contains all subsequent equipment used to set up
therapy
10002 Hemolung Cartridge
Membrane oxygenator with integrated centrifugal
pump
12100 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
13100 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
80101 Hemolung Cartridge Kit IFU
Printed Instructions for Use

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Hemolung Catheter Kit Contents
Ref Product Description
30020 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
30120 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
Ref Product Description
21000 Hemolung Controller - CR4
The reusable part of the Hemolung RAS. This self-
contained unit holds all electronics and monitoring
sensors.

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Controller (Side)
1 Diagnostic Ports Access (Refer to CAUTION)
2 Soda Lime Column
3 Vacuum Canister Port
4 Sweep Gas Port to Hemolung Cartridge
5 O2Inlet Port
6 Air Inlet/Oxygen Exhaust Filters (Porex)
Controller (Back)
7 USB Port
8 AC Power Inlet
9 Grounding Port
The Diagnostic ports must be covered at all times during use
of the Hemolung system. Removal of the Diagnostic Port cover
may result in electrical damage (ESD). The Diagnostic Ports
have no user functionality and should only be accessed by
ALung authorized service personnel.
7
8
9
2
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