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Philips Respironics E30 ventilator -

device training presentation


Julie Yarascavitch, Sr. Global Clinical Applications Manager
April 11, 2020
Emergency Use Authorization

The Philips Respironics E30 Ventilator is not FDA cleared or approved. The
Philips Respironics E30 Ventilator is provided globally for use under local
emergency use authorizations, such as the FDA Emergency Use Authorization
for ventilators, Health Canada Interim Order for use in relation to COVID-19,
and waiver of CE marking, which authorize its use for the duration of the
COVID-19 public health emergency, unless terminated or revoked (after which
the products may no longer be used).
Philips Respironics E30 ventilator fills the
critical hospital ventilation shortage for
COVID-19 patients

The ventilator is authorized for use to treat


patients with respiratory insufficiency

Intended to provide invasive and


noninvasive ventilatory support for
individuals with respiratory insufficiency

Intended Use: The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is
specifically for the care of adult and pediatric patients >7 years of age and >18kgs. It is intended to be used in the hospital or other institutional healthcare environments,
as well as spaces converted for the care of large numbers of COVID-19 patients (e.g. convention centers, university dormitories, motels). The Philips Respironics E30
ventilator is intended for use by qualified, trained personnel under the direction of a physician.
As COVID-19 continues to spread globally, healthcare
providers are working diligently to treat soaring numbers of
patients at a time when there are too few ventilators to
provide care.
Philips is responding to this pressing global need by quickly
scaling production of the new Philips Respironics E30
ventilator with the needs of healthcare workers and COVID-
19 patients in mind while also complying to medical device
quality standards.
This global ventilator solution, can be purchased by
governments and hospitals who are experiencing ventilator
shortages. The Philips Respironics E30 ventilator can be used
when there is limited access to a fully featured critical care
ventilator.
Designed for mass production by a team deeply experienced
in respiratory care, the Philips Respironics E30 ventilator
meets numerous important needs.
Key ventilation features

Interface modality: Noninvasive and invasive (respiratory insufficiency)


Integrated heated humidification (noninvasive use)
Ventilation modes: CPAP, S, S/T, PC
Passive circuit
Pressure range: IPAP: 4 to 30 cm H2O
EPAP: 4 to 25 cm H2O
CPAP: 4 to 20 cm H2O
Patient settable alarms: Circuit disconnection: Off, 15, 60 seconds
Apnea: Off, 10, 20, 30, 40 seconds
Low minute ventilation: 1 to 99 LPM
Breaths per minute settable: Off, 1 to 30 (1-breath increments)
Supplemental low flow oxygen: Patient circuit -up to 30 lpm / device inlet - up to 60 lpm

5
Easy to use Designed for
your safety

Optimized oxygen Key monitoring


delivery and alarms
Easy to use
Quick set-up and simple operations allowing healthcare providers
with a wide range of skill sets to treat and monitor patients.
Device overview
• Device front with humidifier
• Removing the humidifier
• Device back
Device overview: 1 2 3 7
Device front with humidifier
1 Therapy On/Off button
2 Ambient light sensor (not active)
3 Ramp button
4 Door, air entrainment port
(filters and O2 inlet)
5 Display screen
6 Control dial
7 Humidifier

5 6 4
Device overview:
Detaching the humidifier
1 Ensure that the E30 is switched off
before disconnecting the humidifier.
2 Pick up the system, placing one hand on
the E30 and the other on the humidifier.
Press the humidifier release button and
gently pull each component apart.
Device overview:
1 2
Device back
1 Humidifier connector
2 Door, accessory access (SpO2)
3 Air outlet port
4 Power inlet

3 4
Setting up the device power
• Configuration A – External Alarm Module (EAM)
• Configuration B – Uninterrupted Power Supply (UPS)
Device power:
Configuration A
1 Ensure the E30 ventilator is turned off.
To prevent accidental disconnection,
route the power supply cord through
the cord clamp.
2 Plug the external alarm module
connector into the power inlet on the
E30 ventilator. Clamp the cord securely
to the E30 ventilator enclosure.
3 Plug in the power supply to supply power
to the E30 ventilator. Ensure both cables
are secured with cord clamps and verify
that the E30 ventilator and External
Alarm Module are operating properly.

Note: Screwdriver not included


Device power:
Configuration B
1 Ensure the therapy device is turned off.
2 Plug in the AC-DC adaptor into the E30
ventilator. Clamp the cord securely to
the E30 ventilator enclosure.
3 Plug the AC-DC adaptor into the UPS
backup outlets row and then in the
power supply.

Ensure that the UPS remains a


minimum of 2 meters from the E30
ventilator and patient. Do not plug
any other devices into the UPS.
Navigating the menu
• Adjusting therapy settings
Navigating the menu:
Adjusting therapy settings
1 Rotate the control dial to navigate to the
‘Therapy’ tile, then press the control dial
to enter.
2 Choose a therapy mode before editing
the settings. Whilst the ’Mode’ tile is
highlighted green press the control dial.
3 Rotate the control dial to select the mode
you intend to use for therapy. Press the
dial to make the selection.
4 Rotate the control dial to navigate to the
therapy setting you wish to adjust. Press
the dial to select the setting and then
rotate the dial to adjust value.
5 Once you’ve finished adjusting the
therapy settings, press the ‘Therapy
on/off button’ to start therapy.
6 Press the ‘Therapy on/off button’ again to
review the ventilation data for this
therapy session.
Designed for your safety
Recommended circuit set-ups contain a bacterial/viral filter to minimize
exposure for healthcare providers when used invasively or noninvasively
with example accessories that may be used, such as a full-face, non-vented
(without integrated leak) mask, or helmet.
Example Circuit options
These circuit set-ups and accessories are examples provided for information purposes only as not all have been validated for use with the
Philips Respironics E30 ventilator.

Helmet Non-vented mask Invasive use


Circuit set-up: 12
Using helmet

1a External Alarm Module 1a


1b Uninterrupted Power Supply
2 E30 ventilator 11
3 Bacterial/viral filter
Tubing 8
4 1b
5 Oxygen analyzer (optional)
10
6 SpO2 module
7 SpO2 sensor 9
8 Helmet 4
9 Exhalation valve 3
10 Cap end
5
11 Oxygen tubing
12 Oxygen flow meter 2
7

6
Circuit set-up: 11
Using non-vented mask

1a External Alarm Module 1a


1b Uninterrupted Power Supply
2 E30 ventilator 10
3 Tubing
4 O2 inlet port 1b
5 Bacteria/viral filter 9
6 SpO2 module
7 SpO2 sensor 5
8 Exhalation valve 3 8
9 Non-vented mask
10 Oxygen tubing 4
5
11 Oxygen flow meter
2
7

6
Circuit set-up: 12
Invasive use

1a External Alarm Module 1a


1b Uninterrupted Power Supply
2 E30 ventilator 11
3 Tubing
4 O2 inlet port 1b
5 Bacteria/viral filter 10
6 SpO2 module 8 13
7 SpO2 sensor
8 Exhalation valve 3
5 14
9 Closed suction catheter
ETT holder 4
10
5 9
11 Oxygen tubing
12 Oxygen flow meter 2
7
13 Trach adaptor without closed suction
catheter
14 Optional HME (not shown) 6
Optimized oxygen
delivery
Safe entrainment of oxygen (device inlet up to 60 lpm / patient
circuit up to 30 lpm) to deliver high levels of inspired oxygen.
O2 delivery set-up:
Primary Option: O2 inlet port
1 Confirm that the E30 ventilator is
powered OFF then open the door on the
right side of the unit.
2 Remove the blue filter.
3 Removing the door is optional. If this is
desired, pinch the hinges inward and lift
the door up and off.
4 Install the O2 assembly into the slot
where the filter was. Push the assembly
completely in to ensure it’s flush to the
surface of the unit.
5 Attach the air filter to the O2 assembly.
Remove the cap of the O2 inlet port and
connect the tubing from your oxygen
source.

Keep the O2 inlet with the bacteria/viral


filter on it free from blockages.
This circuit set-up and accessories are examples provided for information purposes only as not all

O2 delivery set-up: have been validated for use with the Philips Respironics E30 ventilator

Secondary Option: Patient circuit


entrainment

1
Oxygen can also be added to the circuit
using the oxygen enrichment port in
the location highlighted on the right
between the patient interface and the
exhalation valve.

Both oxygen delivery options can be


used for patients with noninvasive or
invasive interfaces.
O2 delivery set-up comparison

O2 inlet port Patient Circuit entrainment

Oxygen entrainment up to 60 lpm up to 30 lpm

Compensation for Yes No


delivered pressure

Tidal Volume adjustment No Yes, if oxygen > 10 lpm


needed Refer to chart on the next slide

If accurate determination of Fi02 is important, use of the O2 inlet is strongly recommended


FiO2 estimation
O2 inlet port using leak

For example, with a leak of


30 lpm and 15 lpm of oxygen
entrained into the inlet the
estimated FiO2 is 60%.
FiO2 estimation
O2 inlet port using MAP

Assumption: patient interface has


little unintentional leak

MAP = (IPAP/3) + (2*EPAP/3)


assuming an I:E ratio of 1:2

For example,
IPAP = 24 and EPAP = 12, then
MAP = 16
Vt adjustment
Patient Circuit O2 Entrainment

If using > 10lpm oxygen


entrainment into the patient
circuit, use the tidal volume
adjustment for O2 Flow Rate
graph

No tidal volume correction is


required when using the O2
inlet port
Information from the user manual section 7.1.10
FiO2 estimation
Patient Circuit O2 Entrainment using
MinVent

For example, with a MinVent


of 7 L/min and 8 lpm of
oxygen entrained into the
circuit the estimated FiO2 is
50%.
Key monitoring
and alarms
On-screen respiratory monitoring (pressure, tidal volume, RR,
Minute Ventilation, leak and SpO2) as well as visual and audible
alarms to provide pertinent therapy information.
Therapy modes
• CPAP
• S
• S/T
• PC
Therapy modes:
CPAP

Continuous Positive
Airway Pressure
2

1 Patient triggered and cycled breaths.


2 Pressure delivered during both
inhalation and exhalation is the CPAP
pressure setting.
3 All breaths are spontaneous

1
3
Therapy modes:
S

Spontaneous

Patient triggered support.


1 Breaths are spontaneous (patient
triggered and cycled) and pressure
supported.
1 1 1 1
Therapy modes:
ST 6 seconds 6 seconds

Spontaneous / Timed
Patient triggered support with a breath
rate. In this example the breath rate is set
to 10 breaths per minute (every 6 seconds)

1 Pressure supported breath, patient


triggered and cycled. 1 1 2 2

2 Mandatory breath, machine triggered


and cycled.
Therapy modes:
PC 5 seconds 6 seconds 6 seconds

Pressure Control
Patient triggered support with a minimum
breath rate and fixed inspiratory time on all
breaths. In this example the breath rate is set
to 10 breaths per minute (every 6 seconds)

1 1 2 2
1 Assisted breath, patient triggered and
machine cycled.
2 Mandatory breath, machine triggered
and cycled.
Key monitoring
• Therapy delivery
• SpO2 connection
• Alarm options
Key monitoring:
Therapy delivery
1 Press the ‘Therapy on/off button’ to start
therapy.
2 Press the ‘Therapy on/off button’ again to
review the ventilation data for this
therapy session.
Key monitoring:
SpO2 connection
1 Connect the SpO2 accessories: link
module, xpod or similar approved and
then the oxygen sensor
2 SpO2 is visible on the bottom right in the
monitored parameters view

3 Acknowledge the SpO2 message on


screen by clicking the control dial
Key monitoring:
Alarm options
1 Turn the control dial to the Alarms Menu

2 There are three settable audible/visual


alarms: Patient Circuit Disconnect; Apnea;
and Low Min Vent
3 In this example we set the Low Min Vent
to 5
4 If appropriate acknowledge the silence
alarm message by clicking the control
dial.
5 Once appropriate click to clear the alarm
message with the control dial
Visual alarms
• Leak is less that Min Vent
• Leak is less than 0
• Excessive leak
Visual alarms:
Leak is less than Min Vent

Situation:
When leak is less than minute ventilation
the two cells on the data screen will be
highlighted yellow.
The leak in the circuit should be equal to or
greater than the volume of air exhaled by
the patient (MinVent) to adequately remove
CO2 enriched air.

Action and resolution:


- Verify that the leak port isn’t blocked

If the indicator still remains and oxygen is


entrained through the patient circuit:
- Reduce the O2 flow or
- Increase the leak in the circuit.
Once the balance is adequately restored the
yellow highlights will disappear.
Visual alarms:
Leak is less than 0

Only applicable when oxygen is entrained


directly into the patient circuit

Situation:
When leak is less than 0 the cell will be
highlighted orange. As per the indication
above, Min Vent will be highlighted yellow
because the minute ventilation is greater
than the leak. Tidal volume will also be
highlighted yellow because the negative leak
reduces tidal volume accuracy.
A negative leak indicates extra oxygen in the
circuit that is being wasted and not utilized
by the patient.
Action and resolution:
- Reduce the O2 flow or
- if unable to reduce the O2 flow then
increase the leak.
Once the balance is adequately restored the
color highlights will disappear.
Visual alarms:
Excessive leak

Situation:
When leak is excessive the leak and tidal
volume cells will be highlighted yellow.

The patient’s mask may be too loose or


disconnected possibly leading to unfiltered
exhaled gases.
Tidal volume is highlighted yellow because
the excessive leak reduces tidal volume
accuracy.

Action and resolution:


Take appropriate steps to ensure the
patient’s mask is connected and there is
an appropriate seal.
Once leak returns to a stable value the
yellow highlights will disappear.
Additional
Information
Provider Access
Humidifier Use
Provider Access (default)

Info Therapy Alarms Comfort Device My Provider My Setup

If locked, Provider mode can be accessed by following these steps:

1. Supply power to the device (if not already).


2. Once the device is powered, press and hold both the Control Dial and the Ramp button on
the device for at least 5 seconds. (will give you temporary access)
3. Then navigate to the Device menu and turn the Provider Mode back on
Patient Access
If you lock provider access in the Device Menu then you will be in the Patient
Mode with the following menus available
Using the Humidifier (noninvasive only)
Comfort

Fixed or Adaptive (A) humidification

Fixed applies a constant heat on the


humidifier heater plate. Under certain
conditions and settings, this mode can
allow condensation to occur in the tube.

Adaptive adapts the heater plate


temperature to the ambient conditions in
the room, and is designed to not allow
condensation to occur in the tube.
Using the Humidifier (noninvasive only)
Comfort

Humidifier Setting

This setting allows you to choose the


desired humidity setting for the humidifier:
0, 1, 2, 3, 4 or 5.
Easy to use

Designed for
your safety

Optimized oxygen
delivery
Key monitoring and
alarms

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