KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203

Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 20403713560

Nama Dagang / Merek : PURITAN BENNETT™ 840 Ventilator System

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / C

Kategori Produk : Peralatan Anestesi

Sub Kategori : Peralatan Anestesi Terapetik

Jenis Produk : Continuous ventilator.

Tipe / Ukuran : 4-840220DIUA-EN/Terlampir

Kemasan : Unit
Nama Produsen / Pabrikan : COVIDIEN., Ireland
Untuk COVIDIEN LLC., United States
Melalui COVIDIEN PRIVATE LIMITED., Singapore
Nama Pendaftar : PT. MEDTRONIC INDONESIA, DKI Jakarta

Atas dasar lisensi dari : -

Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 12 Maret 2025.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Izin edar ini merupakan persetujuan perpanjangan, perubahan penandaan dan perbaikan nama
dagang dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 20403713560 tanggal 6 Juli
2017. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.
4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.

Jakarta, 05 Oktober 2020

Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
 KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203

LAMPIRAN
NOMOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 20403713560

No. Deskripsi Tipe / Kode

1 MOUNTING KIT 480/730 X1 4-075314-00
2 CARTON PACKING 806 X1 4-076723-00
3 Pole Cart 10035176
4 Pole Cart with 1 hr BPS 10046826
5 Pole Cart with 4 hr BPS 10046827
6 Charging Circuit, Pole Cart 10045573
7 Cylinder Bracket, Pole Cart 10045578
8 Humidifier Kit, Pole Cart 10042364
9 Wall Air Water Trap Bracket 10045588
10 Compressor Cart Kit UPH840C4HR
11 Compressor Mount Cart 10035086
12 Compressor Mount Cart with 1 hr BPS 10046822
13 Compressor Mount Cart with 4 hr BPS 10046823
14 4 hr BPS, Compressor Mount Cart 10045581
15 1 hr BPS, Compressor Mount Cart 10045584
16 Cylinder Bracket, Compressor Cart 10045586
17 Humidifier Kit, Compressor Cart 10045589
18 Mounting Kit, Hudson RCI ConchaTherm Humidifier 4-075312-00
19 840 Ventilator Cart 4-076102-00
20 840 VENTILATOR CART - MALAYSIA F-CUSTOM378-D#

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini

Jakarta, 05 Oktober 2020

Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
 COVIDIEN PURITAN BENNETT™ 840 Ventilator
System

Description Result

Minute 25 to 75 L/min
volume (VE
TOT )
capability

Results of Inspiratory pressure drop from

ventilator inlet of open safety valve to
patient output port without inspiratory
circuit filter:
testing At 5 standard liters per minute
(using (SL/min): 0.06 cmH2O
circuits At 30 standard liters per minute
identified for (SL/min): 0.28 cmH2O
use with the At 60 SL/min: 0.95 cmH2O
Puritan Inspiratory pressure drop across
Bennett™ inspiratory
840 filter:
Ventilator At 5 SL/min: 0.17 cmH2O
System At 30 SL/min: 0.56 cmH2O
At 60 SL/min: 1.37 cmH2O

Inspiratory pressure drop from

inlet of open
safety valve with inspiratory filter:
At 5 SL/min: 0.17 cmH2O
At 30 SL/min: 0.84 cmH2O
At 60 SL/min: 2.32 cmH2O

Maximum 127.5 cmH2O (125 hPa)

limited
pressure

Maximum 100 cmH2O (98.1 hPa), ensured

working by high pressure limit 90 cmH2O
pressure (pressure-based ventilation)

Diproduksi: COVIDIEN, Ireland Untuk COVIDIEN LLC, United States Melalui COVIDIEN PRIVATE LIMITED, Singapore
Diimpor: PT. Medtronic Indonesia, Jakarta – Indonesia
KEMENKES RI AKL ……………………
Puritan Bennett™ 840 Ventilator
 Your Foundation for Ventilation Impressive Standard Features are Just the Beginning
Excellence The Puritan Bennett™ 840 ventilator provides a solid foundation on which to build your ideal ventilation
solution. With the addition of optional advanced technology upgrades, this ventilator can meet the
Healthcare providers and patients throughout the world depend on Covidien
specific needs of practically every patient type you care for—from neonatal patients weighing as little as
for state-of-the-art ventilation therapy. Whether your needs include acute
300 grams to adult patients weighing as much as 150 kg.
care for critically ill patients with chronic respiratory failure or a solution to
transition patients to home care, we have the right system for the task at hand.

Healthcare professionals know all too well the range of issues that affect
DualView LCD Touch Screen
ventilation outcomes today. At Covidien, our innovations are systematically Provides an intuitive, easy-to-use
interface with an “at-a-glance” format
tackling the issues that truly matter: patient safety, clinician support and that allows quick interpretation of data
medical efficacy. The Puritan Bennett™ 840 ventilator is another example of and immediate adjustment of settings

how we’re helping medical professionals improve ventilation outcomes and

quality of life for their patients.

THREE DIMENSIONS OF EXCELLENCE BUILT INTO EVERY PURITAN

PATIENT SAFETY
BENNETT™ 840 VENTILATOR
Noninvasive Ventilation (NIV) Mode
HEALTHCARE EFFICIENCY
Patient Safety—Alarm systems, high-efficiency filters and self-diagnostic Greater flexibility for all patient ranges
with noninvasive ventilation
MEDICAL EFFICACY testing work in concert to help ensure that the Puritan Bennett 840 ventilator
delivers effective and efficient ventilation.

Medical Efficacy—The intuitive user interface of the Puritan Bennett 840

ventilator, combined with our commitment to clinician support, which
Puritan Bennett™ 806 Compressor (optional)
includes optional custom software and accessible technical support, create a Improves versatility by providing an
alternative air source if compressed wall
ventilation solution that is in line with your clinical needs. air or bottled air is unavailable

Healthcare Efficiency—The Puritan Bennett 840 ventilator can be customized Puritan Bennett™ 840 Ventilator Cart
with advanced technology focused on supporting patient-ventilator Offers easy maneuverability, lightweight
performance and full functionality
synchrony.1 Improved patient-ventilator synchrony has been shown to in a cost-effective package

facilitate spontaneous breathing,2 thereby reducing days on ventilation,3

patient costs and risks associated with mechanical ventilation.

A HISTORY OF INNOVATION
Covidien is committed to protecting your investment by continuing to develop features that improve patient care and outcomes. Since
its inception, the Puritan Bennett™ 840 ventilator has undergone a steady stream of improvements and enhanced functionality that are
backward compatible with all Puritan Bennett 840 ventilators.
YOU LIVE AND BREATHE
EXCELLENCE IN
Respiratory Mechanics
VENTILATORY CARE. Puritan Bennett™ 840 NeoMode (RM) and New Trending- Leak
Ventilator Introduction Software VV+ NIV enabled (TE) Board + Compensation
SO DO WE.
1998 > 1999 > 2000 > 2001 > 2002 > 2003 > 2005 > 2006 > 2007 > 2008 > 2009
Bi-Level Mode Larger GUI Electromagnetic PAV *+
™
Trending NeoMode
Tube Compensation and Communication Interference (EMI) Upgrade
Upgrades Extended
Backup
Power Source

Heated expiratory filter—
Traps pathogens from the
expiratory breath, helping
limit the spread of hospital-
acquired infections.
Help improve patient comfort
with the Puritan Bennett™ 840
ventilator Patient Support
Software Package.5†
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Promoting Safety for Patients
and Clinicians
The Puritan Bennett™ 840 ventilator provides medical professionals with
reliable, proven ventilation tools and technology you need for safe and
effective ventilation of your patients. This includes a full suite of features
focused on both patient safety, and the safety of hospital staff and
hospital visitors, including the following:
• Circuit disconnect detection—Monitors circuit pressure and effective
patient volume to reliably detect circuit disconnection
• Automatic patient detection—Designed to prevent inadvertently
setting the ventilator into any type of standby condition in which there is
no ventilation
• Ongoing background checks—Continuously assesses the proper
function of the ventilator’s electronics and pneumatics hardware during
ventilation
• Heated expiratory filters—Trap pathogens from the expiratory breath,
helping limit the spread of hospital-acquired infections**
A unique expiratory heating process shields patients and clinicians from
exposure to viruses and bacteria from exhaled gases. Combined with the
N100-rated filter, the Puritan Bennett™ 840 ventilator heated expiratory
filtration system is capable of filtering 99.97% of particles of the most
penetrating size.4
EXTENDING VENTILATORY EXCELLENCE ACROSS
YOUR ORGANIZATION
Many facilities must ensure that their ventilators are ready to support
any patient type, in any area of care. The NICU is one area that presents
unique ventilatory challenges, requiring a truly specialized approach. In
order to accommodate this need, the Puritan Bennett™ 840 NeoMode
2.0 software option brings a full suite of functionality that is focused on
effective and accurate ventilation of neonates, including the ability to
provide BTPS compensated tidal volume delivery as small as 2 mL for
neonates weighing as little as 300 grams.
†
The Volume Ventilation Plus Software option for the Puritan Bennett 840 Ventilator is a standard feature of the Puritan Bennett™ 840
Increasing the EƬciency of Your
Ventilation Strategy
Achieving patient-ventilator synchrony is essential to improving the efficiency
of ventilatory support. The Puritan Bennett™ 840 ventilator can be customized
with advanced technology that can help maintain patient-ventilator synchrony.1
Improving synchrony has been shown to facilitate spontaneous breathing2 and
reduce days on ventilation,3 thereby reducing patient costs and risks associated
with mechanical ventilation. This advanced technology is reflected in the
following features:
• Proportional Assist™* Ventilation Plus (PAV™*+) Software—Delivers positive
airway pressure that is proportional to your patients’ inspiratory efforts during
spontaneous breathing
Help improve patient-ventilator
• Volume Ventilation Plus (VV+)—Offers improved comfort and synchrony, while synchrony with the Puritan
offering a way to maintain targeted tidal volumes with minimal required pressure Bennett™ 840 ventilator Dynamic
Patient Support Software
• Bi-Level Mode—Uses augmented pressure ventilation for unrestricted Package.6
spontaneous breathing at any moment of the ventilatory cycle
Other features focused on improving healthcare efficiencies include the
following:
• Leak Compensation—Improves neonatal ventilatory care by helping to minimize
the effect of leaks associated with both invasive and noninvasive ventilation
• Tube Compensation—Automatically compensates for resistance in gas flow
through the endotracheal or tracheostomy tube
• Trending Software—Monitors patient data and events for up to 72 hours and
trends up to 58 parameters
ENHANCED SAFETY AND EFFICIENCY THROUGH EXTENDED BATTERY LIFE
Whether there’s a power outage because of a natural disaster or an intrahospital
transfer, the battery life of the ventilator dictates whether another means of
ventilation is necessary. The Puritan Bennett 840 ventilator with the Puritan
Bennett™ 803 extended backup power source (BPS) helps minimize these risks by
providing four hours†† of continuous battery backup power during power outages
or other emergencies.
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 PURITAN BENNETT™ 840 VENTILATOR SETTINGS
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Helping Clinicians Achieve the Best Pos-
sible Outcomes
Medical professionals want an intuitive, easy-to-use and thoughtfully
designed user interface that clinical staff can easily adopt and operate.
The Puritan Bennett™ 840 ventilator features the DualView LCD touch
screen, providing one screen dedicated to patient monitoring and another
screen dedicated to ventilator settings. This makes it easier to read
VENTILATOR OPTIONS FOR EVERY AREA OF
CARE
Whether you choose one of our prebuilt ventilators
or to simply upgrade the base Puritan Bennett™ 840
ventilator with the software and hardware packages
that fit your needs, the end result is a cost-effective,
highly efficient ventilator solution designed to help
you improve ventilation outcomes and quality of life
for your patients.
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mandatory ventilation (SIMV), or spontaneous (SPONT), Bi-Level
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Compensation, Bi-Level, Volume Ventilation Plus (Volume
Control Plus and Volume Support), Proportional Assist™*
Ventilation Plus (PAV™*+), Respiratory Mechanics and Trending
Mandatory breath types: Volume Control (VC), Pressure Control
(PC) or Volume Control Plus with Volume Ventilation Plus option
Spontaneous breath types: Pressure Supported (PS), Volume
Supported (VS), Proportional Assist (PA), none
Vent type: Invasive or Noninvasive
Pressure support (PSUPP): 0 to 70 cm H2O
Rise time %: 1% to 100%

patient data while making immediate adjustments of settings. The Puritan Expiratory sensitivity (ESENSWR/PLQWR/PLQZLWK
PAV™*+
1. Puritan Bennett™ 840 Neonatal Ventilator
Bennett 840 ventilator also supports communication with certain patient Tidal volume (VT): 25 to 2,500 mL, 2 to 315 mL with NeoMode
Tidal volume—2 mL to 315 mL
monitoring and hospital information systems. Patient weight—300 g to 7 kg 5HVSLUDWRU\UDWHIWRPLQWRPLQZLWK1HR0RGH
2. Puritan Bennett™ 840 Pediatric-Adult Ventilator 3HDNLQVSLUDWRU\ƫRZ9MAXWR/PLQIRU,%:!NJWR
When it comes to the service and support of your ventilation solution, Tidal volume—25 mL to 2,500 mL /PLQIRU,%:ƦNJWR/PLQZLWK1HR0RGH
Covidien offers some of the most comprehensive field service programs Patient weight—7 kg to 150 kg Flow pattern: Square or descending ramp
The Puritan Bennett™ 840
Long-Term Care Software
Package upgrade from Covidien
3. Puritan Bennett™ 840 Universal Ventilator Plateau time (TPLWRVHFRQGV
in the ventilator industry. From field-based warranty and repair services
Tidal volume—2 mL to 2,500 mL
Inspiratory pressure (PI): 5 to 90 cm H2O
to free online educational programs at our Center for Clinical Excellence, Patient weight—300 g to 150 kg
Constant during rate change: Inspiratory time (TI), I:E ratio or
Covidien provides a wide range of support for the Puritan Bennett expiratory time (TE)
can help improve synchrony1 for 840 ventilator. Inspiratory time (TIWRVHFRQGV
critically ill, long-term patients, ,(UDWLRƦ
while providing advanced
Expiratory time (TE7(ƧVHFRQG
assessment capabilities. 
APPLICABLE SOFTWARE OPTIONS Trigger type: Pressure (PTRIGRUƫRZ9TRIG)ORZE\ƫRZWULJJHULQJ

FOR EACH CONFIGURATION Pressure sensitivity (PSENSWRFP+2O below PEEP

Flow sensitivity (VSENSWR/PLQWR/PLQZLWK
NeoMode O2%: 21% to 100%
1 2 3
PEEP: 0 to 45 cm H2O
NeoMode 2.0 Software Apnea ventilation: Apnea mandatory type-volume control (VC)
or pressure control (PC)

Neonatal Lockout $SQHDƫRZSDWWHUQ6TXDUHRUGHVFHQGLQJUDPS

$SQHDSHDNƫRZ9MAXƧ/PLQWRƦ/PLQƧ/PLQWR
Noninvasive Ventilation (NIV) Ʀ/PLQƧ/PLQWRƦ/PLQ
PROVIDE FULL RANGE OF PATIENT CARE
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THROUGH EXCELLENT SOFTWARE PERFORMANCE P/IRUSHGDGXOW
Leak Compensation
Apnea inspiratory pressure (PI): 5 to 90 cm H2O
Gas leakage is particularly troublesome during noninvasive ventilation Tube Compensation Apnea inspiratory time (TIWRVHFRQGV
because noninvasive interfaces. This new software feature optimizes the Apnea interval (TA): 10 to 60 seconds
Bi-Level Mode
Puritan Bennett™ 840 ventilator’s performance as a noninvasive ventilator, $SQHDUHVSLUDWRU\UDWHIWRPLQ

offering a single-platform solution that allows clinicians to provide a full Volume Ventilation Plus Apnea O2%: 21% to 100%
Apnea expiratory time (TEƧVHFRQGV
spectrum of care. The Puritan Bennett™ Leak Compensation software can
Proportional Assist™* Ventilation Plus Disconnect sensitivity (DSENS): 20% to 95% or OFF in NIV
help overcome the challenges of leakage and of maintaining synchrony
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during either invasive or noninvasive ventilation. The Leak Compensation Respiratory Mechanics nonheated expiratory tube or heated expiratory tube

software option compensates for leaks up to 15 liters per minute (Lpm) for +XPLGLƪFDWLRQYROXPHWRP/
Trending
Patient circuit type: Pediatric, adult or neonate with NeoMode
neonates, 40 Lpm for pediatric patients and 65 Lpm for adults. option
 ORDERING INFORMATION
Standard Accessories
(Included in PB840 Main Equipment) Catalog Number Humidiƪers and Accessories Catalog Number
RE/FLEX FILTER 22MM X1 407460000
Humidiƪers
FILTER EXHALATION REUSABLE X1 407030500
Fisher & Paykel MR 850 Humidiƪer 230V MR850
VIAL EXH FILTER REUSEABLE 840 407464700
Fisher & Paykel MR 850 Humidiƪer 115V -
FLEXARM ASSEMBLY 403200600 MR850JHU
Taiwan and Guam Chamber
TUBE HANGER SIMPLIFIED 402072400
Humidiƪcation Chamber Adult MR370
TUBE ASSY SILICONE 21 LITRE 401850600
Humidiƪcation Chamber Infant MR340E
TEST LUNG 400061200
HOSE ASSY AIR HIGH PRESSURE 400654100 Bracket

ASSEMBLY HOSE HIGH PRESSURE 400147400 Mounting Bracket 900MR304

Operator’s and Technical Reference Breathing Circuit

Manual Puritan Bennett™ 800 Series 10067720
Ventilator System Adult Breathing Circuit Kit 900MR761
Infant Breathing Circuit Kit 900MR749
Software Options Catalog Number Neonatal Bias Flow Breathing Circuit Kit 900MR780
NeoMode 2.0 Software Option 10051496
Heater Wire Adapter
Tube Compensation Software Option 407637000
Inspiratory Heater Wirer Adapter 900MR858
Bi-Level Software Option 407627000
Volume Ventilation Plus Software Option 407812800 Temperature Probe
Trending Software Option 10020407 for use with circuits 1.1m 900MR868
PAV™* + Option Kit 407820400 for use with circuits 1.3m 900MR860
Respiratory Mechanics Option Kit 10019217 for use with circuits 1.5m 900MR869

Optional Accessories Catalog Number Filters and Sensors Catalog Number

Puritan Bennett ™ 840 Ventilator Cart and Accessories Inspiratory Bacteria Filter
Puritan Bennett™ 840 Ventilator Cart RTA Package x1 407610200 Reusable ƪlter (Re/Flex, each) 407460000
Puritan Bennett™ 840 Ventilator Cart - Malaysia TFCUSTOM378D# D/FLEX FILTER INHALATION SPU X12 407460100
Puritan Bennett™ 803 BPS 10030274 Expiratory Bacteria Filter and Collector Vial
806 Compressor 220V English French x1 407632600 Reusable ƪlter (Re/X800, each) 407030500
806 Compressor 120V English French x1 407632900 Reusable collector vial (Re/X800, each) 407464700
Puritan Bennett™ 840 Ventilator Compressor Mount Cart and Accessories Seal, expiratory ƪlter 407031100
Puritan Bennett™ 840 Ventilator Compressor Mount Cart 10035086 D/X800 EXP FILTER ASSY, SPU, [BOX OF 12] 407688700

Cylinder Mount Bracket Kit 10045586 Neo Filter and Adapter

Wall-Air Water Trap Kit 10045588 Neo disposable ƪlter (carton of 12) 407640800
Universal Humidiƪer Mounting Bracket 10045589 Neo ƪlter adapter 407640500
1 Hour Charging Circuit 10045584
Nebulizer Catalog Number
4 Hour Charging Circuit 10045581
Aeroneb®* Pro Nebulizer System AGAP6000IN
Puritan Bennett™ 840 Ventilator Pole Cart and Accessories
Proximal Flow Sensor and Option Kit Catalog Number
Puritan Bennett™ 840 Ventilator Pole Cart 10035176
Puritan Bennett 840 Ventilator Proximal Flow Sensor,
™
Cylinder Mount Bracket Kit 10045578 10047078
Neonatal (10-pack)
Wall-Air Water Trap Kit 10045588
Puritan Bennett 840 Ventilator Proximal Flow Option Kit
™ ††
10047083
1 Hour Charging Circuit 10045572
Operator's manual Addendum, Proximal Flow System
4 Hour Charging Circuit 10045577 10047088
Option Introduction
Pole Charging Circuit 10045573
††
The 800 series ventilator system must be running International English software version 4-070000-85 1. The PAV™*+ ventilation mode, available on the Puritan Bennett 840 Ventilator,
Revision AK or higher (or the equivalent translated software version). has been shown to increase patient-ventilator synchrony compared to pressure support ventilation.
Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted
mechanical ventilation. Intensive Care Med. 2006;32(10):1515-1522.

2. Xirouchaki N, Kondili E, Vaporidi K, et al. Proportional assist ventilation with load-adjustable gain factors
in critically ill patients: comparison with pressure support. Intensive Care Med. 2008;34(11):2026-2034.

3. Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during

assisted mechanical ventilation. Intensive Care Med. 2006;32(10):1515-1522.

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