PHILIPS A30 EFL EFL Ventilator User Manual

: June 17, 2024
: Philips

Table of Contents

PHILIPS A30 EFL EFL Ventilator
Introduction
Cleaning, Disinfection, Service
Cleaning the Ventilator: Exterior
Cleaning the Reusable Tubing
Limited Warranty
References
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PHILIPS A30 EFL EFL Ventilator

PHILIPS-EFL-EFL-Ventilatr-priouct

Specifications

Model: BiPAP A30 EFL, A40 Pro/EFL
Manufacturer: Philips
Cleaning Frequency: Ventilator exterior – weekly, Reusable tubing – every 6 months
Disinfection Method: Isopropyl Alcohol, Chlorine Bleach solution

Product Usage Instructions:

Cleaning and Disinfection Overview
It is essential to regularly clean and disinfect your BiPAP A30EFL or A40 Pro/EFL ventilator to ensure proper functioning and hygiene.

Introduction

The following information is in addition to the information presented in the Introduction chapter in the BiPAP A30 EFL and A40 Pro/EFL manuals. The operator of the ventilator is responsible to read and understand this addendum before use.

Warnings and Cautions

Warning : Use only the cleaning methods outlined in this addendum. Philips is unable to verify the safety or performance of any device if ozone or other unapproved cleaning and disinfection methods are used.
Note: Any damage caused by unapproved ozone cleaning and disinfection methods or other unapproved cleaning and disinfection methods will not be covered by the Philips Limited Warranty.

Cleaning, Disinfection, Service

The following information replaces the information presented in the Cleaning, Disinfection, and Service information chapter in the BiPAP A30 EFL and A40 Pro/EFL manuals. The operator of the ventilator is responsible to read and understand this addendum before use.

Cleaning and Disinfection Overview

| Home cleaning| Home Disinfection| Hospital Cleaning| Hospital Disinfection
---|---|---|---|---
Ventilator Exterior

5 year life, cleaned and disinfected weekly and between patients (975 cycles maximum)

| Solution of mild liquid dishwashing detergent and potable water

Clean weekly

| 70% Isopropyl Alcohol

If available, lint-free cloth with chlorine bleach (6.0% sodium hypochlorite), 1:9 part reduction in potable water

Disinfect weekly

| Solution of mild liquid dishwashing detergent and potable water

Clean weekly and between patients

| 70% Isopropyl Alcohol

DisCide® Ultra Towelettes *

Lint-free cloth with chlorine bleach (6.0% sodium hypochlorite), 1:9 part reduction in potable water PDI® Super Sani- Cloth® Disinfect weekly and between patients

Air Path| N/A| Note: Use an inlet filter in addition to either a bacteria filter or replacement of gas (air) pathway components in between patient use (see Air Path Cross Contamination section)| N/A| Note: Use an inlet filter in addition to either a bacteria filter or replacement of gas (air) pathway components in between patient use (see Air Path Cross Contamination section)
Reusable Tubing

6 month life, cleaned weekly
(61 cycles maximum)

| Solution of mild liquid dishwashing detergent and potable water

Clean weekly and dispose of between patients

| N/A| Solution of mild liquid dishwashing detergent and potable water

Clean weekly and dispose of between patients

| N/A
Reusable Gray Foam Filter| Rinse monthly and replace every six months.

Note: If soil is visible during inspection, rinse more frequently.

| N/A| Rinse weekly and replace monthly

Note: If soil is visible during inspection, rinse more frequently.

Note: An in-line bacteria filter must be used in clinical environment.

| N/A
Roll Stand| Solution of mild liquid dishwashing detergent and potable water

Clean as needed

| 70% Isopropyl Alcohol

If available, lint-free cloth with chlorine bleach (6.0% sodium hypochlorite), 1:9 part reduction in potable water

Disinfect as needed

| Solution of mild liquid dishwashing detergent and potable water

Clean weekly, as needed and between patients

| 70% Isopropyl Alcohol

DisCide Ultra Towelettes

Lint-free cloth with chlorine bleach (6.0% sodium hypochlorite), 1:9 part reduction in potable water

Disinfect weekly, as needed and between patients

---|---|---|---|---
Carrying Case| Dispose of between patients| N/A| Dispose of between patients| N/A
Bacteria Filter| IMPORTANT: Use an in-line bacteria filter in the clinical environment. The bacteria filter should be disposed of weekly and between patients.
O 2 Enrichment Attachment| IMPORTANT: The O 2 Enrichment Attachment is for single patient use. Dispose of weekly and after each patient. Replace when tubing is replaced.
Whisper Swivel II| **Note: For more information on caring for accessories, refer to the instructions for use that came with the accessory. Review all applicable instructions for additional warnings and cautions.
In-Use Bag (wheelchair bag)
Detachable Battery Pack
Detachable Battery Module**

Cleaning the Ventilator: Exterior

WARNING: To avoid electrical shock, always unplug the power cord from the wall outlet and remove battery cables before cleaning the device.
WARNING: DO NOT immerse the device in any fluids.
WARNING: If using the therapy device on multiple users, discard and replace the bacteria filter each time the device is used on a different patient.
The therapy device’s exterior surface should be cleaned weekly or more often if necessary and between patients.
Note: Before cleaning the therapy device, remove the reusable gray foam filter and disposable white ultra-fine filter (if using). For more information, refer to “Caring for the Filters”.
Turn the therapy device off.

Disconnect from the power source.
Detach all accessories and connectors.
Wipe using a lint-free cloth dampened (not dripping) with a mild liquid dishwashing detergent solution (such as Dawn® Ultra Dishwashing Liquid)* for one minute, to clean the exterior of the enclosure. Use 1 teaspoon (5 ml) of liquid dishwashing detergent per gallon (3.8 L) of potable water.
Pay close attention to all corners and crevices of the therapy device exterior surfaces. Be sure all visible soil is removed.
Wipe with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently, to remove all detergent residue.
Inspect the therapy device for cleanliness.
Repeat the cleaning steps until the exterior surfaces are visibly clean.
Allow to air dry completely.
Inspect the therapy device for damage after cleaning. If any parts are damaged, contact Philips Respironics Customer Service. Replace any damaged parts.

CAUTION: Allow the therapy device to dry completely before reconnecting to the power source.

Dawn is a registered trademark of Procter & Gamble.

Disinfecting the Ventilator: Exterior

CAUTION: Only the cleaning and disinfection procedures listed in this manual are recommended by Philips Respironics. Use of other cleaning and disinfection procedures, not specified by Philips Respironics, cannot be guaranteed to maintain the performance or durability of the product.
Follow all instructions from the manufacturer of the disinfectant product. Any deviation from these instructions, the manufacturer’s instructions, or agents not listed in these instructions may impact the performance of the product.

Disinfect the therapy device exterior surface weekly or more often if necessary and between patients.

Note: Before disinfecting the therapy device exterior, follow the instructions in the section, “Cleaning the Ventilator: Exterior”.
Note: Before disinfecting the therapy device, remove the reusable gray foam filter and disposable white ultra-fine filter (if using). For more information, refer to “Caring for the Filters”.
Note: Remove the detachable battery module from the therapy device before disinfecting. Inspect the therapy device for damage. If any part is damaged, contact Philips Respironics Customer Service.

Use one of the following agents to disinfect all exterior surfaces of the therapy device as indicated: Isopropyl Alcohol – 70% isopropyl alcohol.
- Use a lint-free cloth dampened (not dripping) with alcohol to thoroughly wipe the exterior surfaces of the enclosure for 5 minutes.
- Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all disinfectant residue.
- Allow to air dry completely.
  DisCide Ultra Towelettes – Pre-moistened disinfecting cloths.
- Dispense towelettes through the lid of the dispenser.
- Use the towelettes to thoroughly wipe the exterior surfaces of the enclosure for 1 minute.
- Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all disinfectant residue.
- Allow to air dry completely.
  Chlorine Bleach – Containing 6.0% sodium hypochlorite. Combine 9 parts potable water to 1 part bleach (if available in the home).
- Use a lint-free cloth dampened (not dripping) with the bleach solution to thoroughly wipe the exterior surfaces of the enclosure for 2 minutes.
- Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all disinfectant residue.
- Allow to air dry completely.
  PDI® Super Sani-Cloth®
- Use PDI Super Sani-Cloth Germicidal Disposable Wipes to initially wipe the exterior surfaces.
- Then, use the wipes to thoroughly wet the exterior surfaces for 4 minutes. More than one wipe may be necessary.
- Refer to the manufacturer’s instructions for more information.
- Allow to air dry completely.
  Note: With the detachable battery module separated from the therapy device, pay close attention to common touch points and all corners and crevices of the therapy device, including the mounting surfaces between the battery module and the therapy device.
Inspect the therapy device for damage after disinfection. If any part is damaged, contact Philips Respironics Customer Service. Replace any damaged parts.
Replace the detachable battery and reconnect the detachable battery module to the therapy device. Reconnect to the power source.

CAUTION : Allow the therapy device to dry completely before reconnecting to the power source.

Air Path Cross Contamination

To manage multiple patients, you can select either the use of a bacteria filter or replacement of the gas pathway components in between patient use.
Use a bacteria filter to reduce cross contamination between patients. If a bacteria filter was not used, the gas pathway components must be exchanged between each new patient use.
If a home-based device is returned and assigned to a new patient, clean and disinfect the device according to the procedures in the previous section. For more information about exchanging the gas pathway
components, contact Philips Respironics Customer Service at +1-724-387-4000 or visit www.respironics.com for your local customer service number.
Be certain that any bacteria filter used with this device complies with ISO 23328-1 and ISO 23328-2. To reduce patient or device contamination, you must use a Philips Respironics-approved main flow bacteria
filter on the patient gas outlet port. Filters that are not approved by Philips Respironics may degrade system performance.
Note: When using the bacteria filter, the device performance may be affected. However, the device will remain functional and deliver therapy.
Note: The bacteria filter should be disposed of in accordance with the filter instructions for use and between patients.

Cleaning the Reusable Tubing

Clean the reusable tubing before first use and weekly and dispose of between patients.

Disconnect the flexible tubing from the device.
Completely immerse the tubing in a solution of potable water and a mild detergent. Use 1 teaspoon (5 ml) of liquid dishwashing detergent (such as Dawn Ultra Dishwashing Liquid) per gallon (3.8 L) of potable water for 3 minutes.
During immersion, gently move the tubing back and forth to loosen and adequately remove adhering substances from the tubing and connectors.
Note: Be sure to clean the entire inner surface of the tube by ensuring it is fully immersed in the detergent solution during gentle agitation by hand.
Note: Be sure to thoroughly rinse all soap residue from the connectors and tubing, and air dry completely before the next use.
Rinse thoroughly with potable water for one minute to remove all soap residue from the tube and connectors.
Allow to air dry completely out of direct sunlight.
Visually inspect the tubing for cleanliness, including connectors. Repeat the cleaning steps if not visually clean.
Inspect the tubing for damage or wear (cracking, crazing, tears, punctures, etc.). Discard and replace if necessary.

Note: Refer to the humidifier manual for the instructions on how to clean the heated tube.
Caring for the Filters

Reusable Gray Foam Filter
In the home, rinse the reusable gray foam filter monthly and replace every six months.
In the clinical environment, rinse weekly and replace monthly.
Note: If soil is visible during inspection, rinse more frequently.
Note: An in-line bacteria filter must be used in clinical environment.
CAUTION: Clogged filters may cause high operating temperatures that may affect therapy device performance. Regularly examine the filters as needed for integrity and to check for accumulated debris.

Follow these steps to rinse the reusable gray foam filter

If the device is operating, stop the airflow. Disconnect the device from the power source.
Remove the filter from the therapy device enclosure by gently squeezing the filter in the center and pulling it away from the device.
Rinse the reusable gray foam filter thoroughly with potable water to remove any debris.
Shake the filter to remove as much water as possible.
Examine the filter for cleanliness and integrity.
Allow the filter to air dry completely before reinstalling it. If the filter is damaged, replace it.
CAUTION: Never install a wet filter into the device. Allow sufficient drying time for the filter to air dry completely.
White Ultra-fine Filter
The disposable white ultra-fine filter should be replaced after 30 days of use or sooner if it appears dirty or damaged. DO NOT rinse the ultra-fine filter.
Replace the disposable white ultra-fine filter if it is damaged or has accumulated any debris.
Note: The disposable white ultra-fine filter is inserted between the device and reusable gray foam filter. The reusable gray foam filter must face outward.
Reinstall the filters, inserting the disposable white ultra-fine filter first (if applicable).

Note: Only Philips Respironics-supplied filters should be used as replacement filters.

Cleaning the Roll Stand
Clean the roll stand weekly or more often if necessary and between patients.

Disconnect and remove attached cables, accessories, and devices, before cleaning.
Dampen a lint-free cloth (not dripping) with a mild liquid dishwashing detergent solution (such as Dawn Ultra Dishwashing Liquid) to wipe the roll stand surfaces. Use 1 teaspoon (5 ml) of liquid dishwashing detergent per gallon (3.8 L) of potable water.
Wipe away any visible soil.
Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all detergent residue.
Allow to air dry completely.

Disinfecting the Roll Stand
Disinfect the roll stand weekly or more often if necessary and between patients.
Use one of the following agents to disinfect all exterior surfaces of the roll stand as indicated: Isopropyl Alcohol – 70% isopropyl alcohol.

Use a lint-free cloth dampened (not dripping) with alcohol to thoroughly wipe the exterior surfaces of the roll stand for 5 minutes.
Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all disinfectant residue.
Allow to air dry completely.

DisCide Ultra Towelettes – Pre-moistened disinfecting cloths.

Dispense towelettes through the lid of the dispenser.
Use the towelettes to thoroughly wipe the exterior surfaces of the roll stand for 1 minute.
Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all disinfectant residue.
Allow to air dry completely.

Chlorine Bleach – Containing 6.0% sodium hypochlorite. Combine 9 parts potable water to 1 part bleach (if available in the home).

Use a lint-free cloth dampened (not dripping) with the bleach solution to thoroughly wipe the exterior surfaces of the roll stand for 2 minutes.
Rinse with a lint-free cloth dampened (not dripping) with potable water for one minute, turning the cloth frequently to remove all disinfectant residue.
Allow to air dry completely.

Limited Warranty

The following information replaces the information presented in the Warranty chapter in the BiPAP A30 EFL and A40 Pro/EFL manuals. The operator of the ventilator is responsible to read and understand this addendum before use.
Respironics, Inc., a Philips company (“Philips Respironics”) provides this non-transferable, limited warranty for BiPAP A30 EFL, BiPAP A40 Pro and BiPAP A40 EFL (“Product”) to the customer who originally purchased the Product directly from Philips Respironics.
What this warranty covers: Philips Respironics warrants each new Product will be free from defects in materials and workmanship and will perform in accordance with the Product specifications under normal and proper use and maintenance in accordance with applicable instructions, subject to the exclusions below.
How long does this warranty last: two (2) years from the longer of the date of shipment to the purchaser or date of setup by purchaser for the end user, except:

The warranty period for accessories, replacement parts, and disposables including, but not limited to, circuits, tubing, leak devices, exhaust valves, filters and fuses, is ninety (90) days from the date of shipment to the original purchaser.

What this warranty does not cover:
This warranty does not apply to any software included with the Product as the software warranty is included in the software license. This warranty does not cover damage or injury whether to the Products, personal property, or persons caused by accident, misuse, abuse, Acts of God, water ingress, unapproved ozone cleaning and disinfection methods, other unapproved cleaning and disinfection methods, repair or alteration by anyone other than Philips Respironics or its authorized service center, failure to operate in accordance with the terms of the operating manual and instructions, lack of reasonable care, the discontinuance of a network (e.g. 2G, 3G, etc.) by a carrier (e.g. ATT, Verizon, etc.), or other defects not related to material or workmanship. This warranty is not transferable. If Philips Respironics finds that a Product returned for service or the issue raised is not covered under this limited warranty, Philips Respironics may charge an evaluation fee and return shipping.

What Philips Respironics will do
If a Product fails to conform to the warranties set forth above during the applicable warranty period, Philips Respironics will repair or replace the Product or refund the original purchase price, in Philips Respironics sole discretion. Philips Respironics may use new or remanufactured assemblies, components, and parts in repair and new or recertified refurbished devices for replacement. The balance of the original warranty period will apply to any Product or component of a Product repaired or replaced under this warranty.

Warranty Disclaimer; Limitation of Liability: EXCEPT AS SET FORTH IN THIS LIMITED WARRANTY, PHILIPS RESPIRONICS MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, STATUTORY OR OTHERWISE, REGARDING THE PRODUCT OR ITS QUALITY OR PERFORMANCE. PHILIPS RESPIRONICS SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL PHILIPS RESPIRONICS MAXIMUM LIABILITY UNDER THESE WARRANTIES EXCEED THE ORIGINAL PURCHASE PRICE OR WILL PHILIPS RESPIRONICS BE LIABLE FOR ANY ECONOMIC LOSS, LOSS OF PROFITS, OVERHEAD, OR SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES. Repair, replacement, or return of purchase price by Philips Respironics is the original purchaser’s sole and exclusive remedy under this warranty.

This warranty gives you specific legal rights, and you may also have other rights that vary from state to state. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above exclusion and limitations may not apply to you.
How to get warranty support: Patients contact your local authorized Philips Respironics dealer and dealers contact Respironics, Inc. at: 1001 Murry Ridge Lane, Murrysville, Pennsylvania 15668-8550 +1-724-387-4000

Note: For Australian and New Zealand customers this warranty replaces the warranty included with the user manual.

The following statement is provided to a customer who is a consumer under the Australian Consumer Law: Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and for compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure. This guarantee applies in addition to other rights and remedies available to the consumer under law.
The following statement is provided to a customer who is a consumer under the Consumer Guarantees Act 1993 (NZ): For consumers under the Consumer Guarantees Act 1993 (NZ) who purchase the goods for personal, domestic or household use: Our goods come with guarantees that cannot be excluded under the Consumer Guarantees Act 1993 (NZ).
Philips warrants that the products shall be free from defects of workmanship and materials, and will perform in accordance with the product specifications for a period of two (2) years from the date of purchase from an authorized Philips Homecare Provider. This Warranty covers the replacement or repair at the option of Philips, of any product that has a manufacturing or material defect that is not the result of normal wear and tear, or a natural characteristic of the material used. This Warranty is not transferable and does not cover products used for commercial purposes, and it does not apply to any consumable items (including but not limited to filters, masks, tubes and humidifier chambers).
The customer is responsible for returning the product to an authorized Philips Homecare Provider, and for collecting the product from the Homecare Provider after repair or replacement, at its own cost. Philips is responsible only for the freight cost of transporting the product between the Homecare Provider and Philips. Philips reserves the right to charge an evaluation and postage fee for any returned product where no problem is found following evaluation.
This Warranty does not cover:• products purchased outside of Australia and New Zealand;
- any damage caused as a result of misuse or abuse, modification, tampering with or alteration of the product, pest infestation, liquid egress into the product, or unapproved ozone cleaning and disinfection methods;
- contamination due to cigarette, pipe, cigar or other smoke;
- failure to follow manufacturer’s instruction for use as per the user manual;
- defects that are a consequence of repairs to a product made or attempted by a service provider other than one approved by Philips;
- products that have been subjected to incorrect electrical supply or inconsistent electrical supply or used with inappropriate accessories.
This Warranty is not transferrable in the event of any resale or transfer of products.
To make a claim under this Warranty, contact your Homecare Provider or Philips: