ResMed AcuCare F1-0 Bedienungsanleitung

Hospital masks

User guide

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AcuCare F1-0 AcuCare F1-1 AcuCare F1-4

1 2

4 5

iii

1Port/ Port/ Port/ Port/ Liitäntä/

Złącze

/

端口/ 端口

2 Valve (AcuCare F1-1 and AcuCare F1-4 only)/

Ventil (endast AcuCare F1-1 och AcuCare F1-4)/

Ventil (kun AcuCare F1-1 og AcuCare F1-4)/

Venttiili (vain AcuCare F1-1 ja AcuCare F1-4)/

Zawór (tylko AcuCare F1-1 i AcuCare F1-4) /

阀门(仅限AcuCare F1-1及AcuCare F1-4型号)/

閥門(僅限AcuCare F1-1及AcuCare F1-4型號)

3 Quick release clip/ Clips med snöre för snabb frigöring/

Klemme til hurtig udløsning/ Hurtigutløsningsklips/ Pikairrotuskiinnike/

Zacisk do szybkiego zwalniania/

快速解脱扣钩/ 快速解脫扣鉤

Vent (AcuCare F1-4 only)/ Ventilationsöppning (endast AcuCare F1-4)/

Ventilationsåbning (kun AcuCare F1-4)/ Ventilasjonsåpning (kun AcuCare F1-4)/

Ilma-aukko (vain AcuCare F1-4)/

Otwór odprowadzający powietrze (tylko AcuCare F1-4)/

排气孔(仅限AcuCare F1-4型号)/ 排氣孔(僅限AcuCare F1-4型號)

5 Connector 22M - 22M (AcuCare F1-4 only) /

Anslutning 22M - 22M (endast AcuCare F1-4)/

Konnektor 22M - 22M (kun AcuCare F1-4) /

Connector 22M - 22M (kun AcuCare F1-4) /

Yhdistäjä 22M - 22M (vain AcuCare F1-4) /

Łącznik 22M - 22M

(tylko AcuCare F1-4)

接头22M-22M (仅限AcuCare F1-4型号) /

連接器22M-22M (僅限AcuCare F1-4型號)

S: Small/ Small/ Small/ Small/ Small (pieni)/

Mała

/ 小号/ 小號

M: Medium/ Medium/ Medium/ Medium/ Medium (keskikokoinen)/

Średnia

/

中号/ 中號

L: Large/ Large/ Large/ Large/ Large (suuri)/

Duża

/ 大号/ 大號

Fitting /Tillpassning /Tilpasning /Tilpasning / Sovittaminen/

Zakładanie/ 配戴 / 配戴

F1-0 F1-1

F1-4

1 2 3

4A 4B

4C 5

Removal / Borttagning / Fjernelse / Fjerning /

Pois ottaminen/ Zdejmowanie/ 取下面罩 / 取下面罩

English 1

ENGLISH

Hospital full face masks

Thank you for choosing the AcuCare range.

This guide covers the following variants, which are shown at the front of

the guide:

•AcuCare F1-0 Hospital non-vented full face mask (blue elbow to

indicate that the mask does not include its own passive venting

mechanism or an AAV)

•AcuCare F1-1 Hospital non-vented full face mask with AAV (clear

elbow with "NV" blue dot to indicate that the mask does not

incorporate its own passive venting mechanism)

•AcuCare F1-4 Hospital vented full face mask (clear elbow to indicate

that the mask incorporates a built-in passive venting mechanism and

an AAV).

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

Intended use for AcuCare F1-0

The AcuCare F1-0 mask is a non-invasive accessory used for channeling

airflow to a patient from an active-exhaust-valve ventilator system.

The mask is:

•to be used on patients weighing > 30 kg, for whom non-invasive

positive airway pressure therapy has been prescribed.

•a disposable device, intended for short-term treatment (up to 7 days)

of a single patient, in the hospital environment only.

•intended to be used with breathing circuits or positive pressure

ventilation (PPV) devices that provide their own method of venting

expired or supplemental gasses.

Intended use for AcuCare F1-1

The AcuCare F1-1 mask is a non-invasive accessory used for channelling

airflow to a patient from a positive airway pressure (PAP) device.

The mask is:

•to be used on patients weighing > 30 kg, for whom non-invasive

positive airway pressure therapy has been prescribed.

•a disposable device, intended for short-term treatment (up to 7 days)

of a single patient, in the hospital environment only.

•intended to be used with breathing circuits or positive pressure

ventilation (PPV) devices that provide their own method of venting

expired or supplemental gasses.

Intended use for AcuCare F1-4

The AcuCare F1-4 mask is a non-invasive accessory used for channelling

airflow to a patient from a positive airway pressure (PAP) device.

The mask is:

•to be used on patients weighing > 30 kg, for whom non-invasive

positive airway pressure therapy has been prescribed.

•a disposable device, intended for short-term treatment (up to 7 days)

of a single patient, in the hospital environment only.

Intended patient population/medical conditions

AcuCare F1-0 and F1-1 (Non-Vented)

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).

AcuCare F1-4 (Vented)

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, obstructive sleep apnoea (OSA) and

obesity hypoventilation syndrome (OHS).

English 3

Clinical benefits

AcuCare F1-0 and F1-1

The clinical benefit of non-vented masks is the provision of effective

therapy delivery from a therapy device to the patient.

AcuCare F1-4

The clinical benefit of vented masks is the provision of effective therapy

delivery from a therapy device to the patient.

GENERAL WARNINGS

•As with all masks, some rebreathing may occur at low pressures.

•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 not be worn unless the ventilator system is

turned on and operating properly.

•Follow all precautions when using supplemental oxygen.

•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.

•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.

•The technical specifications of the mask are provided so you can

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 the patient has ANY adverse

reaction to the use of the mask.

•Using a mask may cause tooth, gum or jaw soreness or aggravate

an existing dental condition. If symptoms occur, consult a dentist.

•Refer to your ventilator manual for details on settings and

operational information.

•Do not expose the mask to direct sunlight.

•Remove all packaging before using the mask.

•(AcuCare F1-1 and AcuCare F1-4 only) The elbow and valve

assembly have specific safety functions. The mask should not be

worn if the valve is damaged as it will not be able to perform its

safety function. The mask should be replaced if the valve is

damaged, distorted or torn.

•(AcuCare F1-4 only) The vent holes must be kept clear.

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

The masks in this guide incorporate:

•a standard female 22mm tapered fitting for external connection to the

ventilator

•a standard Luer port for pressure sampling or supplemental oxygen if

required.

Fitting

Notes:

•A sizing template is located on the mask packaging to help you

determine the correct mask size.

•Inspect the mask before use and replace it if any parts are damaged.

•Do not overtighten the straps, as air fills the dual-wall cushion and

provides a comfortable seal.

•For the best seal, the side straps should be tighter than the top strap.

1. Position the mask cushion over the patient's nose and mouth and pull

the headgear over their head.

2. While holding the mask against the patient's face, pull each of the

side straps back along the side of the patient's face. The straps should

English 5

pass below the patient's ears. The side arms on the mask should

bend back as you tighten the straps.

3. Gently adjust the top strap.

4. Start ventilation according to the ventilator system operating

instructions and connect the mask to the ventilator system.

5. If air leaks around the cushion, reposition the mask on the patient's

face to achieve a better seal. You may also need to readjust the

headgear straps.

Removal

1. Unclip the headgear from the mask using the quick release clip.

2. Pull the mask and headgear up over the patient's head.

Cleaning

The mask (with headgear) is disposable and should be discarded if heavily

soiled. If the inside of the mask is lightly soiled, it may be cleaned by

wiping with a clean cloth and water. Do not disassemble the mask.

WARNING

Always follow cleaning instructions. Some cleaning products may

damage the mask, its parts and their function, or leave harmful

residual vapours.

CAUTION

•Do not expose any part of the mask or tubing to direct sunlight as

it may deteriorate.

•If any visible deterioration of a mask system component is

apparent (cracking, discolouration, tears etc.), the mask system

should be discarded and replaced.

•Discard the mask (and headgear) if heavily soiled, particularly if

the vent holes are blocked.

Troubleshooting

Problem/possible cause

Solution

Mask is uncomfortable

Headgear straps are too tight. The cushion membrane is designed to

inflate against the patient's 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. Check the patient's size against the fitting

template located on the mask packaging.

Mask leaks around the face.

Cushion membrane is creased or folded. Refit the mask according to the instructions.

Ensure that you position the cushion

correctly on the patient's face before pulling

headgear over their head. Do not slide the

mask down the patient's face during fitting

as this may lead to folding or curling of the

cushion.

Mask could be the wrong size. Check the patient's size against the fitting

template located on the mask packaging.

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