CorVent RESPOND 19 User manual

Respond 19 Operators Manual (EUA), IFU105, Rev. G, DCO#: 340 Effective 01/25/2021
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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
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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

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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

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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.

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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

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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

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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.

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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)

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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.

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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.