Quattro Air NV - Respiratory medical device ResMed - Free user manual and instructions

USER MANUAL Quattro Air NV ResMed

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ResMed

Quattro Air

NV

Non-vented full face mask

Nors Če Ελληνικά Por Slovenč

User guide

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Technical diagram showing two steps of hairpin tool application: first to draw a cable, second to press a clip with a handle.

Side profile sketch of a person wearing a helmet and holding an oxygen mask (no text or symbols)

Removing your mask using the quick release / Abnehmen der Maske mithilfe der Schnelllöslasche / Retrait de votre masque à l'aide du cordon de retrait rapide / Rimozione della maschera utilizzando la cordicella di sgancio rapido / Borttagning med hjälp av snabbspännets snöre / Tag masken af vha. hurtigudløseren / Ta av masken ved hjelp av hurtigutløsningssnor / Maskin pois ottaminen pikairrotusnauhaa käyttäen / Maski eemaldamine kiirpäästiku abil / Odstranění masky pomocí rychlého uvolnění / Het masker afzetten met behulp van de snelklem / Αφαίρεση της μάσκας σας με χρήση της ταχείας απελευθέρωσης / A maszk eltávolítása a gyorskioldóval / Zdejmowanie maski za pomocą zacisku do szybkiego zwalniania / Remover a máscara usando o elemento de libertação rápida / Снятие маски с использованием устройства для быстрого снятия / Snímanie masky pomocou spony pre rýchle odopnutie / Odstranjevanje maske s hitro sprostitvijo / Retirada de la mascarilla con la liberación rápida / Maskenin hızlı çıkarma ile çıkarılması

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Line drawing of a person wearing a head-mounted medical device with a surgical connector (no text or symbols)

Disassembly / Auseinanderbau / Démontage / Smontaggio / Demontering / Adskillelse / Demontering / Purkaminen / Osadeks lahtivõtmine / Demontáž masky / Demonteren / Αποσυναρμολόγηση / Szétszerelés / Demontaż / Desmontagem / Разборка / Rozobratie / Razstavljanje / Desmontaje / Maskenin sökülmesi

Illustration of a hand holding a tool with a curved arrow indicating rotation (no text or symbols)

Line drawing of a hand holding a plant stem, labeled with number 2 (no text or symbols on the diagram itself)

Illustration of a hand holding a tool with an arrow indicating direction (no text or symbols present)

Illustration showing two steps of a medical procedure: one being adjusted for a tool, the other holding a device (no text or symbols present)

Reassembly / Zusammenbau / Remontage / Riassemblaggio / Montering / Samling / Montering / Kokoaminen / Uuesti kokkupanek / Opětovné sestavení masky / Opnieuw monteren / Елavaσυναρμολόγηση / Ismételt összeszerelés / Ponowny montaż / Nova montagem / Повторная сборка / Opätovné zostavenie / Ponovna sestava / Reensamblaje / Maskenin yeniden montají

Line drawing of a hand fastening a car seatbelt, showing the seatbelt being adjusted (no text or symbols present)

Illustration of a hand holding a tool with an arrow indicating motion (no text or symbols present)

③

④

Illustration of hands holding a tool with a curved object, no text or symbols present

Diagram of a hairpin tool with labeled connector and connector icon, showing internal structure and insertion point.

Illustration of a hand holding a small object with arrows indicating movement or force (no text or symbols)

ENGLISH

Quattro™ Air NV

Non-vented Full Face Mask

Thank you for choosing the Quattro Air Non-Vented (NV) full face mask.

Using this guide

Please read the entire guide before use. When following instructions, refer to the images at the front of the guide.

Intended Use

The Quattro Air NV is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen), intended to be used with active-exhaust-valve ventilators, to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure.

The Quattro Air NV is:

• to be used by patients weighing >30 kg requiring non-life support ventilatory assistance.
• intended for single patient re-use in the home environment and/or multi-patient re-use in the hospital/institutional environment.

Clinical benefits

The clinical benefit of non-vented masks is the provision of effective therapy delivery from a therapy device to the patient.

Intended patient population/medical conditions

Obstructive pulmonary diseases (eg, Chronic Obstructive Pulmonary Disease), restrictive pulmonary diseases (eg, diseases of the lung parenchyma, diseases of the chest wall, neuromuscular diseases), central respiratory regulation diseases, and obesity hypoventilation syndrome (OHS).

GENERAL WARNINGS

- The mask must not be used without qualified supervision for patients who are unable to remove the mask themselves.

• This mask is not for use on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting.
• The mask should only be used with ventilators recommended by a physician or respiratory therapist.
• The mask should not be worn unless the ventilator system is turned on and operating properly.
• Follow all precautions when using supplemental oxygen.
• If oxygen is used with the ventilator, the oxygen flow must be turned off when the ventilator is not operating, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire.
• At a fixed rate of supplemental oxygen flow (if used), the inhaled oxygen concentration varies depending on the pressure settings, patient breathing pattern, mask size selection and leak rate.
• Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. Only use oxygen in well ventilated rooms.
• The technical specifications of the mask are provided for your clinician to check that they are compatible with the ventilator. If used outside specification or if used with incompatible devices, the seal and comfort of the mask may not be effective, optimum therapy may not be achieved, and leak, or variation in the rate of leak, may affect the ventilator function.
• Discontinue using this mask if you have ANY adverse reaction to the use of the mask, and consult your physician or sleep therapist.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
• Refer to your ventilator manual for details on settings and operational information.
• Remove all packaging before using the mask.

Note: For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country.

Using your mask

ResMed has tinted the Quattro Air NV elbow blue to identify it as a non-vented mask.

The Quattro Air NV has a standard female 22mm tapered fitting for external connection to the ventilator.

Use a standard conical connector if pressure readings and/or supplemental oxygen are required.

Fitting

1. Remove the elbow from the mask by pressing the side buttons and pulling the elbow away.
2. With both lower headgear straps released, hold the mask against your face and pull the headgear over your head. Ensure that the label on the back of the headgear faces outwards when the headgear is put on.
3. Undo the fastening tabs on the upper headgear straps. Pull the straps evenly until the mask is stable and positioned as shown in the illustrations. Reattach the fastening tabs.
4. Bring the lower straps below your ears. Loop the headgear onto the frame and clip the quick release together.
5. Undo the fastening tabs on the lower headgear straps. Pull the straps evenly until the mask sits firmly on the chin and reattach the fastening tabs.
6. Start ventilation, then connect the air tubing from your device to the elbow. Attach the elbow to the mask by pressing the side buttons and pushing the elbow into the mask.
7. Undo the fastening tabs on the upper headgear straps. Readjust the straps evenly only enough that a seal is achieved and reattach the fastening tabs. Overtightening may cause leaks.
8. Your mask and headgear should be positioned as shown.

Removing your mask

There are two ways to remove your mask.

Removing your mask normally

1. Unclip the quick release from the frame by pinching the buttons on the sides. You can also remove the lower headgear strap from the hook.

2. Pull the mask away from your face and back over your head.

Removing your mask using the quick release cord

1. Pull the quick release cord down. The quick release clip separates from the mask.
2. Pull the mask away from your face and back over your head.

Disassembly

1. Unhook the upper headgear straps from the frame. There is no need to undo the fastening tabs.
2. Remove the elbow from the mask by pressing the side buttons and pulling the elbow away. Remove the elbow from the air tubing.
3. While holding the bottom of the hook, pull the corner of the frame slightly away from the side of the mask.
4. Remove the frame from the rest of the mask.

Reassembly

1. Press the frame onto the rest of the mask, ensuring it clicks into place at the top and at both bottom corners.
2. Attach the top headgear straps to the frame by looping through each of the upper headgear hooks. Ensure that the ResMed logo on the headgear is facing outward and right side up.
3. If the quick release clip has been removed from the frame, reattach it by threading it onto the lower right headgear hook.
4. If the quick release has been disassembled, reclip the parts together as shown in the reassembly illustrations.
5. If the quick release has been removed from the headgear, thread the lower right headgear strap through the slot on the quick release. Fold the tab over to reattach.
6. Attach the elbow to the air tubing. Attach the elbow and air tubing to the mask by pressing the side buttons and pushing the elbow into the mask. Pull on the elbow to check that it sits securely in the mask.

Cleaning your mask in your home

Your mask and headgear should only be handwashed by gently rubbing in warm (approximately 30^ C) water using mild soap. All components should be rinsed well with drinking quality water and allowed to air dry out of direct sunlight.

WARNING

Always follow cleaning instructions and use mild soap. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours that could be inhaled if not rinsed thoroughly.

CAUTION

If any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.), the component should be discarded and replaced.

Daily/After each use:

• Disassemble the mask components according to the disassembly instructions.
• Thoroughly clean the separated mask components (excluding headgear), by gently rubbing in warm (approximately 30^ C) water using mild soap.
• To optimise the mask seal, facial oils should be removed from the cushion after use.
• Inspect each component and, if required, repeat washing until visually clean.
• Rinse all components well with drinking quality water and allow to air dry out of direct sunlight.
• When all components are dry, reassemble according to the reassembly instructions.

Weekly:

- Handwash the headgear. It may be washed without being disassembled.

Reprocessing the mask between patients

When using between patients, these masks must be reprocessed according to instructions available on ResMed.com/downloads/masks.

Troubleshooting

Problem/possible cause	Solution
Mask is uncomfortable.
Headgear straps are too tight.	The cushion membrane is designed to inflate against your face to provide a comfortable seal with low headgear tension. Adjust straps evenly. Ensure that the headgear straps are not too tight and that the cushion is not crushed or creased.
Mask could be the wrong size.	Talk to your clinician to have your face size checked against fitting template. Note that sizing across different masks is not always the same.
Mask is too noisy.
Elbow incorrectly installed.	Remove the elbow from your mask, then reassemble according to the instructions.
Mask leaks around the face.
Cushion membrane is creased or folded.	Refit your mask according to the instructions. Ensure that you position the cushion correctly on your face before pulling headgear over your head. Do not slide the mask down your face during fitting as this may lead to folding or curling of the cushion.
Mask could be the wrong size.	Talk to your clinician to have your face size checked against fitting template. Note that sizing across different masks is not always the same.
Frame incorrectly fitted.	Remove the rest of the mask from the frame, then reassemble according to the instructions.

Technical specifications

Compatible devices	For a full list of compatible devices for this mask, see the Non-Vented Mask/Device compatibility list at ResMed.com/downloads/masks.
Dead space information	Physical dead space is the empty volume of the mask to the end of the swivel. Using the large cushions it is 214 mL.
Therapy pressure	0 to 40 cm H2O
Resistance	Drop in pressure measured (nominal)at 50 L/min: 0.1 cm H2Oat 100 L/min: 0.5 cm H2O
Environmental conditions	Operating temperature: +5°C to +40°COperating humidity: 15% to 95% non-condensingStorage and transport temperature: -20°C to +60°CStorage and transport humidity: up to 95% non-condensing
Gross dimensionsMask fully assembled with elbow assembly (no headgear)	Extra Small:156 mm (H) x 103 mm (W) x 111 mm (D)Small:156 mm (H) x 103 mm (W) x 112 mm (D)Medium:175 mm (H) x 103 mm (W) x 112 mm (D)Large:175 mm (H) x 103 mm (W) x 112 mm (D)
Service life	The service life of the mask system is dependent on the intensity of usage, maintenance, and environmental conditions to which the mask is used or stored. As this mask system and its components are modular in nature, it is recommended that the user maintain and inspect it on a regular basis, and replace the mask system or any components if deemed necessary or according to the instructions in the 'Cleaning your mask' section of this guide.

Notes:

• The mask system does not contain PVC, DEHP or phthalates.
• This product is not made with natural rubber latex.
• The manufacturer reserves the right to change these specifications without notice.

Storage

Ensure that the mask is thoroughly clean and dry before storing it for any length of time. Store the mask in a dry place out of direct sunlight.

Disposal

This mask and packaging do not contain any hazardous substances and may be disposed of with your normal household refuse.

Symbols

The following symbols may appear on your product or packaging:

Non-vented mask

LATEX?

Not made with natural rubber latex

Medical device

Importer

See symbols glossary at ResMed.com/symbols.

Consumer Warranty

ResMed acknowledges all consumer rights granted under the EU Directive 1999/44/EC and the respective national laws within the EU for products sold within the European Union.

Limited warranty

ResMed Pty Ltd (hereafter 'ResMed') warrants that your ResMed mask system (including mask frame, cushion, headgear and tubing) shall be free from defects in material and workmanship from the date of purchase for the period of 90 days or in the case of disposable masks the maximum use period. This warranty is only available to the initial consumer. It is not transferable. If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This limited warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs; and c) any damage or contamination due to cigarette, pipe, cigar or other smoke. Warranty is void on product sold, or resold, outside the region of original purchase.

Warranty claims on defective product must be made by the initial consumer at the point of purchase.

This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.

ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any

ResMed product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed office.

Warranty information for Australian customers

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 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.

In addition to your rights and remedies under Australian Consumer Law (and any other applicable law), ResMed Pty Ltd ABN 30 003 765 142 of 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 Australia (ResMed) warrants that your ResMed mask system (including mask frame, cushion, headgear and tubing) will be free from defects in material and workmanship from the date of purchase for the period of 90 days or in the case of disposable masks the maximum use period.

To make a claim under this warranty you should contact the ResMed accredited outlet from which you purchased your ResMed product or send your claim to ResMed at 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 Australia (phone number [phone])

(email: [e-mail]). All claims under this warranty must be accompanied by your original receipt.

You will then need to deliver the ResMed product you claim is defective to the ResMed accredited outlet from which you purchased your ResMed product or your closest ResMed accredited outlet at your expense. A similar product will normally be lent to you by your ResMed accredited outlet while your product is assessed.

The product you claim as defective must be delivered from the ResMed accredited outlet to the ResMed Service Centre within the relevant warranty period referred to above. ResMed will not be responsible for the cost of the transport of your ResMed product to the ResMed service centre. You must pay any necessary costs to the ResMed accredited outlet. If ResMed determines that your warranty claim is valid, we will return the repaired product, or a replacement product, to your ResMed

accredited outlet at ResMed's expense. If ResMed determines that your warranty claim is valid you may claim any reasonable expenses you have incurred in making the claim by posting to us at 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 a claim in writing attaching original receipts for the expenses claimed. If ResMed determines that your warranty claim is not valid, we will notify your ResMed accredited outlet by providing a quotation of the cost of repair. Your ResMed accredited outlet will then contact you and you will have the option of taking up the quotation offer, valid for 30 days, or have your product returned unrepaired to your ResMed accredited outlet at ResMed's expense.

This manufacturer's warranty is void on product sold, or resold, outside the region of original purchase.

This warranty gives you specific legal rights. For further information on your warranty rights, contact your local ResMed dealer or ResMed office. If you are provided with a replacement or repaired product, the warranty continues to apply to the replacement or repaired device but does not continue beyond the original warranty period referred to above.

If you have any questions or would like the address of your nearest ResMed accredited outlet, please contact our friendly customer service consultants.

DEUTSCH

Quattro™ Air NV

Maschera oro-nasale non-vented

ALGEMENE WAARSCHUWINGEN

1 Elizabeth Macarthur Drive, Bella Vista, NSW 2153. Australia

See www.resmed.com for other ResMed locations worldwide. For patent and other intellectual property information, see ResMed.com/ip. Quattro and Quattro Air are trademarks and/or registered trademarks of the ResMed family of companies. © 2021 ResMed. 628145/1 2021-05