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

USER MANUAL Quattro FX NV ResMed

3D medical device with transparent visor and blue plastic cap, labeled 'NV ResMED' and 'Cuattro™ FX', no readable text beyond labels.

ResMed

Quattro™ FX NV

NON-VENTED FULL FACE MASK / OHNE LUFTAUSLASSÖFFNUNGEN FULL FACE MASKE / NON- VENTILÉ MASQUE FACIAL / MASCHERA ORO-NASALE

Fitting / Anlegen / Mise en place / Applicazione

Line drawing of a person wearing a helmet and belt, with no visible text or symbols

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Illustration of a person wearing a face mask and holding a medical device, with arrows indicating movement (no text or symbols)

Headgear position / Kopfbandposition / Position du harnais / Posizione del copricapo

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Illustration of a person wearing a helmet and visor, with a cross symbol indicating a warning or disturbance (no text or symbols present)

Side-view line drawing of a person wearing a helmet and mask, with no visible text or symbols

Cushion check / Sitz der Maske / Vérifi cation de la bulle / Verifi ca cuscinetto

NV X

Technical illustration of a mechanical assembly with no visible text or symbols

Diagram showing a person in a vehicle with warning symbol and checkmark, possibly indicating inspection or safety instructions.

Disassembly / Auseinanderbau / Démontage / Smontaggio

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NV

4 NV

5 6

Quattro FX NV

NON-VENTED

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Mask components / Maskenkomponenten / Composants du masque / Componenti della maschera

Item /Article /Article /Elemento	Description / Beschreibung / Description /Descrizione	Part number /Artikelnummer/ Code produit /Codice prodotto
1 Spring frame* / Flexi-Rahmen* / Entourage fl exible* /Supporto elastico*		61759 (S)61760 (M)61761 (L)
2 Frame / Maskenrahmen / Entourage rigide / Telaio 61745 (S)		61746 (M)61747 (L)
3 Cushion / Maskenkissen / Bulle / Cuscinetto 61721 (S)		61722 (M)61723 (L)
4 Soft sleeves / Komforthüllen / Gaines souples /Guaine morbide		61758
5 Ports cap / Anschlusskappe / Bouchon d'entrées /Coperchio degli ingressi		16570 (2)16571 (10)
6 Headgear clip / Kopfband-Clip / Clip d'attache duharnais / Fermaglio del copricapo		61353 (2)
7 Headgear / Kopfband / Harnais / Copricapo 61734 (S)		61733 (M)61738 (L)
8 Spring frame support / Flexi-Rahmenstütze / Supportde l'entourage fl exible / Sostegno del supportoelastico		—
9 Elbow / Kniestück / Coude / Gomito 61762
A Complete system / Komplettes System / Systèmecomplet / Maschera con tutti i componenti		61742 (S)61743 (M)61744 (L)

* Includes 1 & 4 / Einschl. 1 und 4 / Comprend les composants 1 et 4 / Comprende 1 e 4

S Small / Small / Petit / Small M Medium / Medium / Médium / Medium L Large / Large / Grand / Large /

Quattro™ FX NV

NON-VENTED FULL FACE MASK

Thank you for choosing the Quattro FX Non Vented (NV) mask.

The Quattro FX NV channels airflow noninvasively to a patient with or without supplemental oxygen.

Intended use

The Quattro FX NV is intended to be used with active-exhaust-valve ventilator systems, to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure.

The Quattro FX NV is:

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

WARNING

• This 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 not be worn unless the ventilator system is turned on and operating properly.

- At a fixed rate of supplemental oxygen flow (if used), the inhaled oxygen concentration will vary depending on the pressure settings, patient breathing pattern, mask size selection and leak rate.

• 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 fi re.
• 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.

- Remove all packaging before using the mask.

- Ensure the soft sleeves are fitted at all times during use.

Using your mask

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

The Quattro FX NV has a standard female 22mm tapered fi tting for external connection to the ventilator.

Refer to the Technical specifications section in this user guide for information about mask leak, dead space and resistance.

Fitting

Prior to fi tting your mask, remove the spring frame support from the rear of your mask and retain for future use.

The Fitting illustrations section in this guide show the sequence for obtaining the best fit and comfort in using your mask.

Fitting Steps

1. With both lower headgear clips released, position your mask at an angle against your face, ensuring that the top of the cushion contacts your nasal bridge first.
2. Keeping the upper position of the mask in place, swing the lower half of the mask down against your face so that it rests halfway between your bottom lip and chin.
3. Hold the mask firmly against your face and pull the headgear over your head.
4. Bringing the lower straps below your ears, clip the headgear into the lower part of the spring frame.
5. Unfasten the Velcro ^® , pull the upper headgear straps evenly until they are comfortable and firm, and reattach the Velcro
6. Repeat step 5 with the lower headgear straps.

Headgear and Cushion Check

• Ensure your headgear is positioned correctly. Refer to the Headgear check illustrations in this user guide
• The Quattro FX cushion is designed to sit mid-bridge. Refer to the Cushion check illustrations for correct positioning.

Removing your mask

To remove your mask, disconnect the lower headgear clips and pull the mask and headgear up over your head.

Disassembly

Before disassembling your mask, detach the air tubing and unclip the lower headgear clips from the spring frame. Refer to the disassembly illustrations in this guide.

Disassembly steps

1. Remove the elbow assembly from the mask.
2. Gently pull the spring frame away from the frame. Remove the soft sleeves from the spring frame.
3. Gently separate the cushion from the frame.
4. Remove the ports cap.

Reassembly

Refer to the reassembly illustrations in this guide.

Reassembly steps

1. Replace the ports cap.
2. Fit the cushion into the channel of the frame. Fit the top section first, then work your way around, pushing the cushion into the frame. Ensure that the cushion is not twisted or distorted around the frame.
3. Replace the soft sleeves onto the spring frame and align the spring frame with the frame.
4. Starting at the top, gently push and click the spring frame into the frame.
5. Gently push and click each side of the lower spring frame into the frame.
6. Replace the elbow into the mask assembly.

Cleaning your mask in the 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.

Daily/After each use:

• To optimise the mask seal, facial oils should be removed from the cushion after use.
• Handwash the separated mask components (excluding headgear).

Weekly:

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

WARNING

- Do not use aromatic-based solutions or scented oils (eg, eucalyptus or essential oils), bleach, alcohol or products that smell strongly (eg, citrus) to clean any of the mask components. Residual vapours from these solutions can be inhaled if not rinsed thoroughly. They may also damage the mask, causing cracks.

CAUTION

• If any visible deterioration of a system component is apparent (cracking, crazing, tears etc), the component should be discarded and replaced.
• Avoid connecting fl exible PVC products (eg, PVC tubing) directly to any part of the mask. Flexible PVC contains elements that can be detrimental to the materials of the mask, and may cause the components to crack or break.

Reprocessing the mask between patients

This mask should be reprocessed when used between patients.

Cleaning, disinfection and sterilisation instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have internet access, please contact your ResMed representative.

Troubleshooting

Problem/possible cause Solution

Mask is uncomfortable

Headgear straps are too tight.	The cushion membrane is designed to infl ate against the 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 fi tting template. Note that sizing across different masks is not always the same. The Quattro FX cushion is designed to sit mid-bridge.
Headgear is touching top of ears.	Remove and refi t your mask according to the instructions. Check that the top and bottom headgear straps are correctly positioned.Ensure that the Velcro tab is correctly aligned with headgear material and not cutting into top of ear.
Cushion is riding up the face during use.	Check headgear positions against the instructions. Headgear should not be worn too far back on the head. Headgear may be the wrong size. If the problem persists, talk to your clinician.
Spring frame is sitting too close to the eyes.	Your mask could be the wrong size. Talk to your clinician to have your face size checked against the fi tting template.
Mask is too noisy
Ports cap or elbow incorrectly inserted.	Remove the ports cap and elbow from the mask, then reassemble according to the instructions.

Mask leaks around the face

Cushion membrane is creased or folded.	Turn off the device and remove mask. Refi t the mask according to the instructions.Ensure you position the cushion correctly on the face before pulling headgear over the head.Do not slide mask down the face during fi tting as this may lead to folding or curling of the cushion.
Cushion incorrectly inserted into frame.	Remove cushion from frame and reinsert starting at the top. Line up raised section on cushion with recess in top of frame. Ensure the alignment markers at bottom corners of the cushion line up with the indent features on frame. Ensure cushion membrane looks even before refi tting. If the problem persists, talk to your clinician.
Mask could be the wrong size.	Talk to your clinician to have your face size checked against fi tting template. Note that sizing across different masks is not always the same.The Quattro FX cushion is designed to sit mid-bridge.
Spring frame incorrectly fitted to frame.	Remove the spring frame from the frame, then reassemble according to the instructions.

Technical specifications

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 243 mL.
Therapy pressure 4 to 30 cm H _2 O
Environmental conditions	Operating temperature: +5°C to +40°COperating humidity: 15% to 95% non-condensing.Storage and transport: -20°C to +60°CStorage and transport humidity: up to 95% non-condensing.
Gross dimensions	Mask fully assembled with elbow assembly – no headgear.
Small:	121mm (H) x 176 mm (W) x 144 mm (D)
Medium:	130 mm (H) x 176 mm (W) x 144 mm (D)
Large:	140 mm (H) x 176 mm (W) x 144 mm (D)

Notes:

• The mask system does not contain latex, PVC or DEHP materials.
• 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.

To maintain optimum care of your mask, ensure the spring frame support is fitted when travelling.

Disposal

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

Symbols

Caution, consult accompanying documents; LOT Lot number;

REF Part number; EC REP European Authorised Representative;

Temperature limitation; Humidity limitation; Does not contain

latex; manufacturer; Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device; Keep away from rain; This way up; Fragile, handle with care.

Consumer Warranty

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

Quattro™ FX NV

ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

See www.resmed.com for other ResMed locations worldwide.

For patent information, see www.resmed.com/ip

Quattro is a trademark of ResMed.

Velcro is a trademark of Velcro Industries B.V.

© 2023 ResMed.

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Illustration of a hand holding a medical device with a shaded grip, no text or symbols present

Illustration of a person using a tool to adjust or install a mechanical component, with no visible text or symbols.

Illustration of a person performing a neck massage or exercise, with no visible text or symbols

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618313/2 2023-01

QUATTRO FX NV

USER

EUROPE 1

618313