E30 · The Philips Respironics E30 Ventilator is provided globally for use under local emergency...

12
E30 Ventilation solution Clinician quick start guide Emergency Use Authorization 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). This device is not FDA cleared or approved.

Transcript of E30 · The Philips Respironics E30 Ventilator is provided globally for use under local emergency...

Page 1: E30 · 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

E30

Ventilation solution

Clinician quick start guideEmergency Use AuthorizationThe 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). This device is not FDA cleared or approved.

Page 2: E30 · 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

2

Device overview

1 2

3

7

4

5 69

8

10 11

Warning: The DreamStation Heated Humidifier is not for use with intubated patients. For intubated patients, please use an external 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.

1. Therapy On/Off button

2. Ambient light sensor (not active)

3. Ramp button4. Door, air

entrainment port (filters and O

2 inlet)

5. Display screen6. Control dial7. Humidifier

Device front with humidifier

Disconnecting the humidifier

Page 3: E30 · 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

3

1 2

3

7

4

5 69

8

10 11

8. Door, accessory access (SpO

2)

9. Humidifier connector

10. Air outlet port11. Power inlet

Device back

The device is shipped with a heated humidifier, power supply and cord, power monitoring solution, O

2 device inlet assembly, user manual,

associated device instructions and optionally, a Quick Start Guide (QSG).

Page 4: E30 · 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

4

5 Install the O2 assembly into the slot where the lter was. Push the assembly completely in to ensure a tight t �ush to the surface of the unit.

1146484 R00JH 04/05/2020

Respironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 USA

O2 inlet port set-up

1. Set up E30 ventilator and confirm that it is powered OFF. Open the door on the right side 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.

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 a tight flush to the surface of the unit.

6. The unit is ready.

2. Remove the blue filter.

5 Install the O2 assembly into the slot where the lter was. Push the assembly completely in to ensure a tight t �ush to the surface of the unit.

1146484 R00JH 04/05/2020

Respironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 USA

O2 Inlet Port Set-Up Instructions

Set up the E30 Ventilator and con�rm that it is powered OFF.

Open the door on the right sideof the therapy device.

Remove the blue �lter.

Removing the door is optional. If this is desired, pinch the hinges inward and lift the door up.

1

3

4

2

The O2 Inlet Port has been approved for use with the Philips Respironics E30 Ventilator by the Food and Drug Administration (FDA)

under the Emergency Use Authorization (EUA) for use during the COVID-19 public health emergency. Refer to the Philips Respironics E30

user manual for more information.

O2 Inlet Port Set-Up Instructions

Set up the E30 Ventilator and con�rm that it is powered OFF.

Open the door on the right sideof the therapy device.

Remove the blue �lter.

Removing the door is optional. If this is desired, pinch the hinges inward and lift the door up.

1

3

4

2

The O2 Inlet Port has been approved for use with the Philips Respironics E30 Ventilator by the Food and Drug Administration (FDA)

under the Emergency Use Authorization (EUA) for use during the COVID-19 public health emergency. Refer to the Philips Respironics E30

user manual for more information.

O2 Inlet Port Set-Up Instructions

Set up the E30 Ventilator and con�rm that it is powered OFF.

Open the door on the right sideof the therapy device.

Remove the blue �lter.

Removing the door is optional. If this is desired, pinch the hinges inward and lift the door up.

1

3

4

2

The O2 Inlet Port has been approved for use with the Philips Respironics E30 Ventilator by the Food and Drug Administration (FDA)

under the Emergency Use Authorization (EUA) for use during the COVID-19 public health emergency. Refer to the Philips Respironics E30

user manual for more information.

6

7

5 Install the O2 assembly into the slot where the lter was. Push the assembly completely in to ensure a tight t �ush to the surface of the unit.

Attach the air lter to the O2 assembly.

The setup is complete.

1146484 R00JH 04/05/2020

Respironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 USA

6

7

5 Install the O2 assembly into the slot where the lter was. Push the assembly completely in to ensure a tight t �ush to the surface of the unit.

Attach the air lter to the O2 assembly.

The setup is complete.

1146484 R00JH 04/05/2020

Respironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 USA

5 Install the O2 assembly into the slot where the lter was. Push the assembly completely in to ensure a tight t �ush to the surface of the unit.

1146484 R00JH 04/05/2020

Respironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 USA

Page 5: E30 · 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

5

Setting up the device - power

Setting up using an External Alarm Module (EAM)

Setting up using an Uninterrupted Power Supply (UPS)

3. Plug the AC-DC adaptor into the UPS unit and then in the power supply. Ensure that the Uninterruptible Power Supply remains a minimum of 2 meters from the E30 ventilator and patient.

2. Plug in the AC-DC adaptor into the E30 ventilator. Clamp the cord securely to the E30 ventilator enclosure.

1. Ensure the therapy device is turned off.

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.

2. Plug the external alarm module connector into the power inlet on the E30 ventilator. Clamp the cord securely to the E30 ventilator enclosure.

1. Ensure the E30 ventilator is turned off. To prevent accidental disconnection, route the power supply cord through the cord clamp.

At least 2 meters

Note: screwdriver not included

Note: screwdriver not included Note: screwdriver not included

Page 6: E30 · 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

6

Circuit set-up example for helmet

1a. External Alarm Module; or 1b. Uninterrupted Power Supply

(see page 5 for more details)

2. E30 ventilator3. Bacteria/viral filter4. Tubing5. Oxygen analyzer (optional)

6. SpO2 module

7. SpO2 sensor

8. Helmet9. Exhalation valve10. Cap end11. Oxygen tubing12. Oxygen flow meter

O2

O2

75.0

2

3

3

4

5

6

7

8

9

10

11

12

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. The use of oxygen entrainment in the patient circuit up to 30 lpm or through the dedicated device inlet up to 60 lpm has been verified through engineering testing.

1a 1b

Page 7: E30 · 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

7

O2

O2

Circuit set-up example for non-vented mask

2

9

10

11

3

6

5

7

8

5

4

1a. External Alarm Module; or 1b. Uninterrupted Power Supply

(see page 5 for more details)

2. E30 ventilator3. Tubing4. O

2 inlet port

5. Bacteria/viral filter

6. SpO2 module

7. SpO2 sensor

8. Exhalation valve 9. Non-vented mask10. Oxygen tubing11. Oxygen flow meter

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. The use of oxygen entrainment in the patient circuit up to 30 lpm or through the dedicated device inlet up to 60 lpm has been verified through engineering testing.

1a 1b

Page 8: E30 · 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

8

O2

O2

2

9

11

3

54

5 14

7

6

8

10

1a. External Alarm Module; or 1b. Uninterrupted Power Supply

(see page 5 for more details)

2. E30 ventilator3. Tubing4. O

2 inlet port

5. Bacteria/viral filter 6. SpO

2 module

7. SpO2 sensor

8. Exhalation valve9. Closed suction catheter10. ETT holder11. Oxygen tubing12. Oxygen flow meter13. Trach adaptor without closed

suction catheter14. Optional HME (not shown)

O2

O2

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. The use of oxygen entrainment in the patient circuit up to 30 lpm or through the dedicated device inlet up to 60 lpm has been verified through engineering testing.

Circuit set-up example for invasive use

13

12

1a 1b

Page 9: E30 · 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

9

Info

Navigating the menu

1. When powering up the device, the menu screen will be shown. Turn the dial clockwise to navigate to the ‘Therapy’ tile. Press the control dial to begin editing the settings.

2. Before editing the settings you must chose a therapy mode. Ensure that the mode tile is highlighted green and then press the dial.

1. Therapy On/Off buttonDuring therapy, holding this button for 2 seconds will stop therapy but leave the device in standby mode. To turn the E30 off, unplug the power adaptor.

2. Display screen

3. Control dial

1

2

3

Therapy

!

Therapy

cmH2O

10.0CPAP

Mode

Page 10: E30 · 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

10

Navigating the menu (cont.)

4. Once you’ve selected the therapy mode, rotate the control dial to navigate to the therapy setting you wish to adjust. Press the dial to make a selection and then rotate the dial to adjust the selected setting.

5. Once you’ve finished adjusting the therapy settings, press the ‘Therapy on/off button’ to start therapy.

3. Rotate the control dial to select the mode you intend to use for therapy. Press the dial to make the selection.

6. Press the ‘Therapy on/off button’ again to review the ventilation data for this therapy session.

PC

cmH2O

19.7

I

Therapy

PC

Leak

10.0 30 7

440 16 95.0%RR SpO2Vt

cmH2O MinVent

IPAP

20.0PC

Therapy

Mode

Ti

1.2

EPAP

10.0

BPM

16

Therapy

Mode

PC

Page 11: E30 · 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

11

Monitoring visual indicatorsLeak is less than MinVent

SituationWhen 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 CO

2 enriched air.

Action and resolutionVerify that the exhalation port isn’t blocked. If the indicator still remains and oxygen is entrained through the patient circuit you can reduce the O

2 flow or increase the leak in the circuit. Once the

balance is adequately restored the yellow highlights will disappear.

Leak is less than 0

Situation (only applicable when oxygen is entrained directly into the patient circuit)When leak is less than 0 the cell will be highlighted orange. As per the indication above, MinVent 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 resolutionReduce the O

2 flow or if unable to reduce the O

2 flow then

increase the leak. Once the balance is adequately restored the color highlights will disappear.

Excessive leak

SituationWhen 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 resolutionTake 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.

Therapy

PC

Leak

10.0 93 5

410 11 ---RR SpO2Vt

cmH2O MinVent

Therapy

PC

Leak

10.0 4 17

474 15 ---RR SpO2Vt

cmH2O MinVent

Therapy

PC

Leak

10.0 -3 3

212 14 ---RR SpO2Vt

cmH2O MinVent

Page 12: E30 · 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

© 2020 Koninklijke Philips N.V. All rights reserved. Philps Healthcare reservesthe right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication.

www.philips.com

1146491 R02 JH 04/15/2020