CorVent RESPOND 19 User manual

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 1of 152
English
The RESPOND 19 Ventilator
User Manual
REF 3461-03-9000

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 2of 152
Caution: Limited by Federal law to Emergency Use Only per
the FDA - Emergency Use Authorization
The RESPOND 19 Ventilator is under US patent protection (patent
pending)
RESPOND 19 Ventilator is a Registered Trademark of the CorVent Medical
Corporation
Copyright © 2020 by CorVent Medical Inc.
CorVent Medical Inc.
315 West 36th St.
New York, NY, 10018
USA

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 3of 152
WARNING – Emergency Use Authorization
The RESPOND 19 Ventilator has NOT been FDA cleared or approved.
The RESPOND 19 Ventilator has been authorized by FDA under an EUA and is
authorized only for the duration of the declaration that circumstances exist justifying the
authorization of the emergency use of ventilators, ventilator tubing connectors, and
ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of ventilators, ventilator tubing connectors, and
ventilator accessories during the COVID-19 pandemic is terminated under section
564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
WARNINGS – Healthcare Providers
Device Usage, Patient Monitoring and Alternative Ventilation:
The CorVent Respond 19 Ventilator is intended to be used in institution/hospital
applications for Invasive and Non-Invasive (NIV) mechanical ventilation support. It
requires a robust external monitoring system be in place inclusive of functionality and
alarms required for monitoring critically ill and mechanically ventilated patients. Non-
Invasive Ventilation (NIV) may not be available in your geography. Please contact
CorVent Medical Support (Section 9.0) for the availability status of this feature in your
geography.
The RESPOND 19 Ventilator is NOT intended for multiplexing (supporting more than one
patient at one time).
DO NOT use the ventilator at an altitude above 3000m or outside a temperature of 10
Deg C to 30 Deg C. Using the ventilator outside of this temperature range or above this
altitude can compromise the ventilator performance which consequently can result in
degradation of the health of the patient. The Ventilator has only been tested at sea level
and degradations in performance may occur at higher altitudes.
An alternative means of ventilation should always be available whenever the ventilator is
in use (back up ventilator, alternative ventilation equipment, manual resuscitator, or
similar device). Ventilator dependent patients should be continuously monitored by
qualified personnel. These personnel should be prepared to provide alternative therapy
in the event of ventilator failure or inoperative equipment.
Oxygen:
The RESPOND 19 Ventilator is not equipped with an alarm to indicate interruption of the
oxygen supply to the ventilator. If the supply is interrupted, it could result in the FiO2being
lower than the amount set on the unit (down to 21%). Appropriate patient monitoring

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 4of 152
should be used, as medically indicated, such as an alarming pulse oximeter and the
required external Oxygen monitor. Check that the supply is still operational when
assessing the patient.
When administering fixed flow supplemental oxygen, the oxygen concentration may not
be constant. The inspired oxygen concentration will vary and depend primarily on the
minute ventilation. If the minute ventilation increases the delivered FiO2 will be reduced
and if the minute ventilation decreases the delivered FiO2 will increase.
There is a risk of fire if O2buildup within the unit is 25% or higher. The system is designed
to limit the build-up of oxygen within the ventilator to less than 25% via hardware design.
Turn the device on before turning on the oxygen. Turn the oxygen off before turning the
device off. This will prevent oxygen accumulation in the device.
Loss of Power
Upon loss of power the device will alarm and stop working. The Total Loss of Power alarm
will annunciate for greater than two minutes or until the device is properly powered back
on. There is NO internal backup battery. There should be continuous monitoring by
qualified personnel and an alternative means of ventilation is recommended whenever
the ventilator is in use. A UPS must be used with the Ventilator to provide up to 2 hours
of backup power upon total loss of mains power supply.
When a UPS is connected, the Ventilator will NOT indicate when the UPS has switched
from mains supply to backup battery supply. The user must rely upon the UPS alarms to
understand the status of their mains supply and backup battery life using the audio and
visual cues from the UPS. When using a UPS, the UPS will alarm upon:
•A mains supply loss (switchover to internal backup battery) with four beeps every
30 seconds with battery symbol on UPS LCD
•Low battery Condition (battery run-time low) with continuous beeping and symbol
on UPS LCD), as well as overload alarms
•The depletion of the UPS backup battery.
When the UPS battery is completely depleted, the Ventilator Total Loss of Power alarm
will annunciate for >2 minutes.
The RESPOND 19 MUST be used with an external Uninterruptible Power Supply (UPS)
and be plugged into the Hospitals Uninterruptible Backup power supply system (red outlet
or equivalent).
Viral Bacterial filter, Patient Circuit, HME:
The device comes with a proprietary patient circuit, HME and viral bacterial filters – only
replace with CorVent supplied parts. Operating this device with incompatible products
could lead to fatal or other serious injury due to incompatibility.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 5of 152
The system MUST use both the inhalation and exhalation filters at all times to prevent
contamination of the environment and the unit.
Alarms:
The high priority and medium priority alarms have similar auditory indications. These two
alarm priorities are mainly differentiated by visual indications. Red signals a high priority
alarm and yellow signals a medium priority alarm. Please refer to the Alarm section of this
manual for additional alarm information.
PLEASE READ THIS MANUAL BEFORE OPERATING THE SYSTEM

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 6of 152
Table of Contents
1.0 Introduction ........................................................................................................................................... 7
2.0 Intended Use.......................................................................................................................................... 7
3.0 Safety Information................................................................................................................................. 8
3.1 Warnings, Cautions, Notes.................................................................................................................. 8
3.2 Contraindications............................................................................................................................... 20
4.0 Symbols Glossary and Abbreviations .............................................................................................. 21
5.0 System Components, Overview and Performance.......................................................................... 25
5.1 Package Contents ............................................................................................................................. 25
5.2 System Overview and Key Performance Specifications ................................................................... 26
5.3 Ventilator Components and Accessories .......................................................................................... 30
6.0 Using the RESPOND 19 Ventilator .................................................................................................... 33
6.1 Setting Up the Ventilator ................................................................................................................... 33
6.2 Supplying Power................................................................................................................................ 33
6.3 Connecting the Uninterruptible Power Supply (UPS)........................................................................ 35
6.4 Connecting the Breathing Circuit, HME, Viral Filters, and Flow Sensor to Ventilator and Patient.... 36
6.5 Powering the Ventilator On and Operational Verification.................................................................. 40
6.6 Selecting Ventilation Type ................................................................................................................. 42
6.7 Connecting to Oxygen ....................................................................................................................... 44
6.8 Setting Parameters and Patient Ventilation ...................................................................................... 47
6.9 Shutting Down the Ventilator....................................................................................................... 67
6.10 Replacing the Patient Circuit, HME, Viral Filters,........................................................................ 68
6.11 Possible Locations of Contamination.......................................................................................... 69
6.12 Suctioning.................................................................................................................................... 70
7.0 Alarms and Troubleshooting ............................................................................................................. 71
7.1 Device Alarms ................................................................................................................................... 71
7.2 Alarm Audible Indicators ................................................................................................................... 71
7.3 Alarm Message Screens ................................................................................................................... 74
7.4 When an Alarm Occurs ..................................................................................................................... 81
7.5 External Power Fail ........................................................................................................................... 81
7.6 Alarm Summary Table....................................................................................................................... 82
7.7 Troubleshooting................................................................................................................................. 90
7.8 Software ............................................................................................................................................ 92
7.9 System Checkout Procedure............................................................................................................. 92
8.0 Cleaning, Maintenance, Disposal, and Storage ............................................................................. 107
9.0: CorVent Support .............................................................................................................................. 109
10.0 Specifications.................................................................................................................................. 110
11.0 Limited Warranty............................................................................................................................. 124
Appendix 1. Principles of Operation ..................................................................................................... 125

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 7of 152
1.0 Introduction
The RESPOND 19 Ventilator is a light weight, mechanical ventilator that provides
Mandatory, Assist, and Spontaneous breath types for Ventilator dependent adult patients.
It is electro-pneumatically operated, providing automatic, invasive, and non-invasive
mechanical ventilation with a built-in PEEP demand flow system. It is designed to address
the critical aspects necessary to provide a large number of devices for the hospital in
emergency situations. The system does not aim to replace fully featured ICU ventilators,
which are needed for patients who are most critically ill; instead, the device is intended to
serve the larger population of patients who have less severe disease and can be
supported with basic ventilation, so as to free up ICU ventilators for patients in dire need.
The system is designed to operate in pressure controlled and pressure support modes to
facilitate ease of use. Clinicians can optimize oxygenation and ventilation via standard
inputs: Respiratory Rate, Inspiratory Time, Pressure Targets, Oxygen, and PEEP. The
patient may be ventilated spontaneously, with mandatory/assist modes, or a combination
therein. Safety features include adjustable patient alarms such as High and Low
Inspiratory Pressure Limits, Disconnect, High and Low Exhaled Tidal Volume, Apnea, and
High Respiratory Rate. These features constitute the basic functionality needed for the
ventilator to provide a life-supporting capacity.
The RESPOND 19 system design leverages known technology in ventilators. The
Ventilator supports patients by controlling the speed of a micro-blower motor. It is
electrically powered and does not require external supply of compressed air. Basic
operating specifications are provided in this manual and are consistent with other
currently available ventilators operating ranges for Mandatory and Spontaneous methods
of Ventilation. The ventilator has an air pathway specifically designed to minimize the
spread of airborne contaminants.
2.0 Intended Use
The RESPOND 19 Ventilator is an electrically powered ventilator intended to provide
continuous, invasive, or non-invasive ventilatory support for the care of adult patients (of
at least 60 lbs.) who require mechanical ventilation.
The RESPOND 19 Ventilator is intended for use in a hospital, or similar clinical
environments, by qualified, trained personnel under the direction of a licensed
physician. Personnel must become thoroughly familiar with these instructions prior to
using the RESPOND 19 Ventilator.
It is recommended for the personnel that use the RESPOND-19 Ventilator to contact
CorVent Medical at +1 (833) 770 - VENT, at [e-mail], and/or online
at CorVentMedical.com for additional training.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 8of 152
3.0 Safety Information
3.1 Warnings, Cautions, Notes
Warning: Indicates the possibility for injury to the patient or the operator
System Characteristic
Warning
Device Usage
Operating this device for unintended purposes or with
incompatible products could lead to fatal or other serious
injury.
The RESPOND 19 Ventilator is NOT intended for
multiplexing (supporting more than one patient at one
time).
DO NOT use a sharp object when pressing keypad to
adjust Ventilation settings.
Do NOT cover the ventilator or place in a position that
affects proper operation
Do NOT position next to a curtain that blocks the flow of
cooling air, thereby causing the equipment to overheat,
thereby interfering with patient ventilation.
Do NOT block the gas intake port or emergency intake
port, thereby interfering with patient ventilation
Do NOT block the fan intake or otherwise cover or position
the ventilator in a way that adversely affects its operation
or performance. For example, positioning the
ventilator next to a curtain that blocks the flow of cooling
air can cause the ventilator to overheat and shut down,
resulting in patient injury.
Use of accessories, transducers and cables other than
those specified or provided by CorVent Medical could
result in increased electromagnetic emissions or
decr
eased electromagnetic immunity of this equipment
and result in improper operation.
Patient Monitoring
A clinical assessment (per clinician institutional standards)
should be made prior to placing a patient on the ventilator
to determine:
•Device alarm settings
•Alternative ventilation equipment needed
•Additional external monitors to be used (oximeter
(SpO2), blood pressure)
•Required External Oxygen Monitor
•Required External CO2 Monitor for NIV
(Capnography)

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 9of 152
System Characteristic
Warning
Backup Ventilation
An alternative means of ventilation should always be
available whenever the ventilator is in use (back up
ventilator, alternative ventilation equipment, manual
resuscitator or similar device).
Ventilator dependent patients should be continuously
monitored
by qualified personnel. These personnel
should be prepared to provide alternative therapy in the
event of ventilator failure or inoperative equipment.
Qualified Personnel
The RESPOND 19 Ventilator is intended for use by
properly trained personnel under the direct supervision of
a licensed medical Physician or Practitioner only.
Personnel must become thoroughly familiar with this
Operators Manual prior to using the RESPOND 19
Ventilator on a patient.
This manual serves as a reference. The instructions in
this manual are not intended to supersede the physician’s
instructions regarding the use of the RESPOND 19
Ventilator.
The RESPOND 19 Ventilator is not intended to be
operated by patients or laypersons.
Adults only
The RESPOND 19 Ventilator has been designed for use
on adult patients greater than 60 lb. DO NOT
use on
neonatal, infant, or pediatric patients.
Alarm
High-Medium Priority
The high priority and medium priority alarms have similar
auditory indications. These two alarm priorities are mainly
differentiated by their visual indicator of LED color (Red –
High, Yellow – Medium) and frequency (1.5 Hz - High, 0.7
Hz – Medium) at a 50% duty cycle.
Alarms
Setting any alarm limits to extreme high or low values, can
cause the associated alarm not to activate during
ventilation, which reduces its efficacy for monitoring the
patient and alerting the clinician to situations that may
require intervention.
The operator should check to ensure current alarm
settings are appropriate prior to use on each patient. If not
properly adjusted, this could effectively disable the alarm,
and could lead to missing the detection of hazardous
situations. This could occur if the user is trying to disable
a nuisance alarm.
The Alarm settings are not maintained when the system is
powered down. They revert to default values upon power
on.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 10 of 152
System Characteristic
Warning
Loss of power
Upon loss of power the device will alarm and stop working.
Immediately after power interruption the alarm system is
unable to restore the alarm settings and the subsequent
behavior of the alarm system. The time of powering down
is not captured upon loss of power.
There is NO internal backup battery. Upon loss of power
the device will alarm and stop working. There should be
continuous monitoring by qualified personnel and an
alternative means of ventilation is recommended
whenever the ventilator is in use. The ventilator must be
used with an Uninterruptible Power Supply (UPS) and be
plugged into the hospital’s uninterruptible emergency
power system.
Obstruction
There is no protection device in place to allow
spontaneous breathing when obstruction occurs
at a
pressure drop less than 6,0 hPa (6,0 cmH2O).
Uninterruptible Power
Supply
The UPS is not intended to be used to power your
RESPOND 19 Ventilator, but for backup power purposes
in the event of an unexpected loss of power.
When a UPS is connected, the Ventilator will NOT indicate
when the UPS has switched from mains supply to backup
battery supply. The user must rely upon the UPS alarms
to understand the status of their mains supply and backup
battery life using the audio and visual cues from the UPS.
When using a UPS, the UPS will alarm upon:
•A mains supply loss (switchover to internal backup
battery) with four beeps every 30 seconds with battery
symbol on UPS LCD
•Low battery Condition (battery run-
time low) with
continuous beeping and symbol on UPS LCD), as well as
overload alarms
•The depletion of the UPS backup battery. When the
UPS battery is completely depleted, the Ventilator Total
Loss of Power alarm will annunciate for >2 minutes.
The UPS must be placed at least 2 m (6.5 ft) away from
the RESPOND 19 Ventilator and patient.
Be certain to plug the UPS power cord directly into a wall
outlet and not into a surge protector.
Do NOT plug any other device into the UPS to ensure that
the indicated backup battery life can be achieved.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 11 of 152
System Characteristic
Warning
The Uninterruptible Power Supply is NOT automatically
maintained in a fully usable condition, it must be
periodically checked per manufacturer recommendations,
with replacement of power source as needed.
Oxygen
When administering fixed flow supplemental oxygen, the
oxygen concentration may not be constant. The inspired
oxygen concentration will vary and depend primarily on
the minute ventilation. If the minute ventilation increases
the delivered FiO2
will be reduced and if the minute
ventilation decreases the delivered FiO2
will increase.
Appropriate patient monitoring should be used, as
medically indicated, such as an alarming pulse oximeter.
Check that the supply is still operational when assessing
the patient.
It is the responsibility of the responsible organization to
ensure that the oxygen source is compatible with the rated
range of pressure, flowrate and oxygen concentration as
marked on the ventilator and indicated in the instructions
for use as this can affect the performance of the ventilator
that can consequently result in patient death or serious
deterioration of health.
An alarm will not sound on the Ventilator if there is an
interruption to the O2 supply. If the supply is interrupted, it
could result in the FiO2 being lower than the amount set
on the unit (down to 21%). Appropriate patient monitoring
should be used, as medically indicated, such as an
alarming pulse oximeter and the required external
alarming Oxygen monitor.
There is a risk of fire if O2 buildup within the unit is 25%
or higher. The system is designed to limit the build-up of
oxygen within the ventilator to less than 25% via hardware
design.
Turn the device on before turning on the oxygen. Turn the
oxygen off before turning the device off. This will prevent
oxygen accumulation in the device.
Explanation of the
warning
: When the device is not in operation and the
oxygen flow is left on, oxygen delivered into the tubing
may accumulate within the device’s enclosure. Oxygen
accumulated in the device enclosure will create a risk of
fire. The design of the hardware and component selection
minimizes the risk of fire; however, it is necessary to follow
good practices when working with Oxygen.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 12 of 152
System Characteristic
Warning
Use an SpO2 monitor to verify patient’s oxygenation level.
The oxygen supply must comply with local regulations for
medical oxygen. Ensure the oxygen connector is
connected an oxygen supply and not another gas. Follow
the oxygen connection instructions carefully.
DO NOT connect the device to an unregulated or high-
pressure oxygen source. The Supply pressure to the
Flowmeter must be within recommended tolerances for
the flowmeter (typically, 50-55 PSI).
Oxygen supports combustion. DO NOT use in the
presence of an open flame or while smoking.
DO NOT use the device near a source of toxic or harmful
vapors.
DO NOT use the device in the presence of a flammable
anesthetic mixture in combination with oxygen or air, in the
presence of nitrous oxide, or in an oxygen rich
environment.
To reduce the risk of fire, use the ventilator in well-
ventilated areas.
To reduce patient risk of oxygen toxicity, keep free-flowing
oxygen away from air inlet of ventilator.
Interdependent Functions
Due to the design of the ventilator (see Appendix 1-
Principles of Operation) the patient settings are
interdependent. The Pressure Target, Inspiratory Time,
and Respiratory Rate controls are all calibrated controls
however the system will ensure that the output is
physically possible due to the constr
aints of the system
design. To ensure that the system is not incapable of
reaching the settings desired, the ranges on all other
patient settings will update in relation to any proposed
change to ensure that the user is aware of the systems
capability.
CO2 rebreathing
DO NOT block the exhalation port which is located in the
center of the Ventilator front panel. This can reduce airflow
and result in rebreathing of exhaled air.
DO NOT position next to curtains, bedding, clothing that
could block the air inlet. Blocking the flow of air could lead
the device to interfere with patient ventilation, potentially
leading to CO2 rebreathing.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 13 of 152
System Characteristic
Warning
Failure to use the patient circuit, Flow Sensor, filters, and
HME provided by the company that minimize the risk of
rebre
athing of carbon dioxide or permit spontaneous
breathing can cause asphyxiation.
Nebulization or
Humidification
Caution when using a nebulizer as it may cause
aerosolization of pathogens. If used, place after the HME,
proximal to the patient.
When using nebulization, the breathing system filter will
require more frequent replacement to prevent increased
resistance or blockage.
The ventilation supplied to the patient can be adversely
affected by the gas added by the use of a pneumatic
nebulizer.
DO NOT use heated humidifiers as they may compromise
the filter efficacy.
Humidification can increase the resistance of breathing
system filters, and the operator must monitor the breathing
system filter frequently for increased resistance and
blockage
to ensure the delivery of the therapeutic
pressure.
Other Gases
DO NOT use the ventilator with other gases other than
room air and wall oxygen.
Device Startup
Make sure the device is working properly at startup by
following the instructions in section 6. Contact CorVent if
the listed testing does not work.
Biocompatibility
All ventilator components comprising the airway, and the
means of attachment to the patient are
comprised of
commercial off the shelf (COTS) components
. Material
Safety Data Sheets (MSDS) Sheets are on file
with the
Manufacturer.
Non Invasive (Mask
Based Ventilation)
The exhaled volume and exhaled CO2 of the patient can
differ from the measured e
xhaled volume and exhaled
CO2 due to leaks around the mask.
Patient Circuit
DO NOT use electrically conductive or antistatic patient
breathing circuits. The only approved and compatible
patient circuit for use with RESPOND 19 Ventilator is the
circuit listed this manual. Any other patient circuit could
result in degraded ventilator performance which could
lead to patient injury.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 14 of 152
System Characteristic
Warning
DO NOT attempt to sterilize or reuse single use complete
patient circuit or its
components (Flow Sensor, Patient
Circuit Tubing, Filters, and HME) as it could lead to patient
infection, degraded performance, and system
contamination.
DO NOT add any attachments or accessories to the
ventilator that are not intended for use in combination with
the ventilator, as the ventilator might not function correctly
leading to the risk of patient death or serious degradation
of patient health
Inspect the Patient Breathing Circuit, Filters, and HME for
wear or damage. DO NOT use if damaged. Only replace
with CorVent supplied Patient Breathing Circuit, Filters, or
HMEs.
DO NOT pull or stretch the tubing – this could result in
circuit leaks.
The RESPOND 19 Ventilator has not been tested for
safety during defibrillation.
To reduce the likelihood of disconnection and to prevent
adverse ventilator performance use only accessories
compatible with the ventilator.
DO NOT place the Flow Sensor in contact with the patient.
The Flow Sensor is heated to prevent condensation and
may exceed 30°C depending on ambient temperature.
The maximum temperature rise is less than 5°C above
ambient temperature. Ensure the Flow Sensor is not in
direct contact with the patients’ skin.
The system will alarm if the Luer connections on filters and
HME are not sealed. Ensure that they are sealed at all
times or an alarm state can occur.
HME
An HME is included with the ventilator for use in the patient
circuit and MUST be placed as instructed in this manual
to humidify air and have the unit function as intended.
Only replace with CorVent supplied HME’s per the
instructions in this manual. Use of non CorVent supplied
HME’s may lead to the ventilator not functioning properly
and subsequent patient harm.
Viral Filters/
Contamination Protection
Viral bacterial filters are included with the ventilator to
prevent contamination. These filters MUST be installed in
the patient circuit in the TO and FROM patient port
connections per the setup instructions to prevent
contamination of the environment and the unit.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 15 of 152
System Characteristic
Warning
Only replace with CorVent supplied viral bacterial filters –
use of alternative filte
rs could negatively impact the
performance of the device, serious injury and/or
contamination of the environment and unit.
DO NOT remove, reverse orientation, or reuse filters as it
may contaminate the environment or ventilator, and/or
degrade the performance.
DO NOT switch the inhalation and exhalation patient
circuit limbs once patient ventilation has begun to
minimize the risk of aerosolizing exhaled bacterial & viral
particulates.
DO NOT install Viral Filters or HMEs that are wet. Replace
any wet filter before continuing operation.
Flow Sensor
Use ONLY CorVent provided Flow Sensor components.
The system will Alarm for “Flow Sensor Reversed” if the
Flow Sensor is placed incorrectly.
Improperly functioning
Ventilator
If a fault is detected in the ventilator, disconnect the patient
from it and immediately start ventilation with alternative
device. The defective ventilator must be removed from
clinical use and sent back to CorVent if possible.
If any unexplained changes in the performance of the
device are noticed, if it is making unusual or harsh sounds,
or if the device or
power supply are dropped or
mishandled, discontinue use and contact CorVent
support.
Power Supply
ONLY use the power supply provided by CorVent.
The main plug of the power supply is used as a means of
isolation/disconnection. DO NOT position the ventilator so
that it is difficult to unplug the power cord from the wall
outlet.
Route the power cord to the outlet in such a manner that
will prevent the cord form being tripped over or interfered
with by chairs or other furniture.
This device is activated when the power cord is
connected.
Ensure that an Audible click is heard when connecting the
locking external 24V universal power supply cable to the
RESPOND 19 Ventilator. This ensures a locked
connection, lowering the risk of unintended power cable
exertion which could lead to Ventilator
Total Loss of
Power.
The Ventilator DOES NOT have an internal battery.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 16 of 152
System Characteristic
Warning
The RESPOND 19 MUST be used with an external
Uninterruptible Power Supply (UPS) and be plugged into
the Hospitals Uninterruptible Backup power supply
system (red outlet or equivalent).
EMC
Care must be taken when operating this equipment
around other equipment to avoid reciprocal interference.
Potential electromagnetic or other interference could
occur to this or to the other equipment. Try to minimize this
interference by not using other equipment in conjunction
with this device.
This Medical Equipment is designed to comply with IEC
60601-1-
2: 2014. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed
and used in accordance with in
structions, may cause
harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not
occur in a particular installation. Harmful interference to
other devices can be determined by turning this
equipment on and off. Try to correct the interference using
one or more of the following:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment to an outlet on a different
circuit from that to which the other device(s) are connected
• Consult your authorized dealer for help
Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
inches) to any part of the
RESPOND 19 Ventilator,
including cables specified by the manufacturer.
Otherwise, degradation of the performance of this
equipment could result.
Maintenance
DO NOT attempt to service the unit. If any defects are
present, contact CorVent Medical support.
DO NOT operate the ventilator or use any of the
accessories if there are signs of damage or it is not
working properly. Periodically inspect power cord, patient
circuit, filters, HME, and Flow Sensor for damage and
replace if necessary.
NO modification of this equipment is allowed.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 17 of 152
System Characteristic
Warning
Cleaning
DO NOT spray the device with any water or cleaners or
immerse in any fluids. If necessary, wipe the device with
a cloth dampened with an approved cleaner. To avoid
electrical shock, always unplug the power cord from the
wall outlet and/or external power supply mo
dule before
cleaning the device.
DO NOT attempt to sterilize the ventilator with autoclave
or ethylene oxide. Doing so will destroy the ventilator.
DO NOT immerse the ventilator in water or any fluids
DO NOT allow liquid or sprays to penetrate the ventilator
openings or cable connections
DO NOT use pressurized air to clean or dry the ventilator
Not MRI safe
The RESPOND 19 Ventilator is not intended for use within
Magnetic Radiation (MR) environment.
Operating Environment
DO NOT use the ventilator at an altitude above 3000m or
outside a temperature of 10 Deg C to 30Deg C. Using the
ventilator outside of this temperature range or above this
altitude can compromise the ventilator performance which
consequently can result in degradation of the health of the
patient. The Ventilator has only been tested at sea level
and degradations in performance may occur at higher
altitudes.
Condensation may damage the device. If the device has
been exposed to either very hot or very cold temperatures,
allow it to adjust to room temperature (operating
temperature) before starting therapy. Do not operate the
device outside of the operating temperature range shown
in the Specifications chapter in the Operator Manual.
DO NOT use the RESPOND 19 Ventilator in conjunction
with anesthetics or in contaminated (hazardous,
explosive) atmospheres. Only compressed oxygen may
be used.
This ventilator is portable meaning it is intended to be
carried but not operating from one location to another.
The RESPOND 19 Ventilator is not intended for use as an
emergency transport ventilator.
DO NOT stack the ventilator on other equipment. Place on
flat surface large and strong enough to support the weight
and stability of the device.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 18 of 152
System Characteristic
Warning
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this
equipment and the other equipment should be observed
to verify that they are operating normally.
Hyperbaric Use
DO NOT use the ventilator in a hyperbaric chamber or
other similarly oxygen-enriched environments.
Such use
might cause the ventilator to not function correctly,
causing patient death or serious deterioration of health.
High Altitude
The RESPOND 19 is not suitable for use at high altitudes
(above 3000m). The Ventilator has only been tested at
sea level and degradations in performance may occur at
higher altitudes.
Latex and Phthalates
The components, devices, accessories and packaging
that make up the ventilator DO NOT
contain any dry
natural rubber, phthalates, or natural rubber latex, which
may cause allergic reactions.
Electric Shock
To reduce the risk of electric shock from liquid entering the
device, DO NOT put a container filled with a liquid on or
near the ventilator.
To avoid the risk of electric shock this equipment must be
connected to a supply main with a protective earth.
EM Interference
The RESPOND 19 Ventilator may cause radio
interference or may disrupt the operation of nearby
equipment. It may be
necessary to take mitigation
measures, such as re-orienting or relocating the ventilator
or shielding the location.
Software
Due to the rapid development cycle for this emergency
use device, all efforts were made to verify the software,
but defects may s
till exist. The consequences of these
defects are unknown and may pose a potential risk to the
patient.
There are no known unresolved software anomalies and
workarounds.
The CorVent System will not be subject to digital
cyberattacks because there are no data ports that the user
may access without the use of a tool. It will take
dismantling the device to gain access to a port. The device
also does not contain any wireless devices.

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 19 of 152
System Characteristic
Warning
There are no known or unresolved anomalies that can
lead to the compromise of sensitive information or that can
affect communication security due to system not having
capability to interface with external systems.
EMC
This ventilator has not been tested for electromagnetic
compatibility (EMC). It may produce electromagnetic
disturbances that will affect the performance of other
equipment. It may fail to perform as expected in the
presence of electromagnetic disturbances from other
equipment.
Use of non-approved accessories, transducers or cables
may increas
e EMC emissions or decrease the EMC
immunity performance of the equipment.
Nitric Oxide
The ventilator shall not be used with nitric oxide. Such use
might cause the ventilator to not function correctly,
causing patient death or serious deterioration of health
Helium Gas Mixtures
The ventilator shall not be used with inlet gases, which are
not specified for use (e.g. helium or mixtures with helium).
Such use might cause the ventilator to not function
correctly, causing patient death or serious deterioration of
health.
Caution: indicates the possibility of damage to the device
System Characteristic
Caution
Condensation
Condensation may damage the device. If the device has
been exposed to either very hot or very cold
temperatures, allow it to adjust to room temperature
(operating temperature) before starting. DO NOT
operate the device outside of the temperature range
shown in the specifications section later in this manual.
Device Placement
DO NOT place the device in or on any container that can
collect or hold water
DO NOT place the device directly onto carpet, fabric or
other flammable materials
DO NOT plug the device into an outlet controlled by a
wall switch
Ensure the ventilator is placed on a flat stable surface or
secured to a stand
DO NOT use extension cords with this ventilator.
Cleaning
DO NOT immerse the device in any liquid or allow any
liquid to enter the vent or inlets

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
Page 20 of 152
DO NOT use harsh detergents, abrasives or brushes to
clean the ventilator. Refer to recommended cleaning
procedures in Section 8.
Alarms
The alarm changes are NOT STORED upon powering
down or at total loss of power.
The alarm pre-sets (Defaults) are the same for each
RESPOND-19 ventilator, are un-editable, and reset to
Default upon power cycling.
See the Limited Warranty section of this manual for information on warranty coverage
3.2 Contraindications
The RESPOND 19 Ventilator is contraindicated in the following situations:
- Active Pneumothorax
- Neonatal, Infant, and Pediatric patients
- Use of this device may be contraindicated depending on the status of DNR
type instructions in your location. Please consult your legal advisor for specific
guidelines in this matter.