ResMed Hospital Mask User Manual

Hospital Mask

NON-VENTE D FULL FACE MASK

The ResMed Hospital NV (non-vented) Full Face Mask is a disposable non-invasive device used for channelling air flow with or without supplemental oxygen.

Intended Use

The ResMed Hospital NV Full Face Mask is intended:

• to be used with active-exhaust-valve ventilator systems, to provide ventilatory

assistance to patients with respiratory insufficiency and respiratory failure.

• to be used on adult patients (>30 kg), requiring non-life-support ventilatory

assistance.

• for single-patient use, for a maximum of seven days, in the hospital or clinical

environment.

. WARNINGS and CAUTIONS

• This mask must not be used without qualified supervision for patients who are

unable to remove the mask by 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 the mask leak.

• If oxygen is used with the ventilator, the oxygen flow must be turned off when

the ventilator is not operating. Explanation: When the ventilator is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the ventilator enclosure. Oxygen accumulated in the ventilator enclosure will create a risk of fire. This warning applies to most types of ventilators.

• Please refrain from smoking while oxygen is in use.

• Leak or variation in the leak may cause mistriggering of the ventilator.

• In determining ventilator settings, and in particular the tidal volume for volume-

cycled ventilators, make appropriate allowance for mask dead space and leak.

• As with all mask ventilation systems, significant leak may occur between the

mask and the patient's face. The leak may vary depending on such factors as the patient ventilation, potentially producing profound hypoventilation or hyperventilation. The magnitude of this effect depends on the ventilator's ability to compensate.

English

About the Mask

• This mask does not contain latex, PVC or DEHP materials. If the patient has any

reaction to any part of the mask system, discontinue use.

• ResMed has tinted the Hospital NV Full Face Mask elbow blue to identify it as a

non-vented mask for use with active exhaust non-invasive ventilator systems only.

• The mask has a standard female 22 mm tapered fitting (ISO5356-1) for external

connection to the ventilator.

Fitting the Mask

The ResMed Hospital NV Full Face Mask is supplied fully assembled.

Note: Inspect the mask and replace it if any parts are damaged.

headgear

side strap

top strap

port cap

quick release clip

side arm

1 Select the correct mask size using the fitting template provided on the package. 2 Place the mask cushion over the patient’s nose and mouth and pull the headgear

over their head.

3 Gently tighten the headgear straps:

a first pull the side straps back along the side of the patient’s face b then adjust the top strap.

Note: Make sure the side straps pass below the patient’s ears. The side arms on the mask bend back as you tighten the side straps. Do not overtighten the straps, as air fills the dual-wall cushion and provides a comfortable seal.

4 Connect the mask to the ventilator system, and initiate air flow, according to the

ventilator system operating instructions.

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.

elbow

Back view

Removing the Mask

To remove the mask, squeeze one of the quick release clips, and pull the mask and headgear up over the patient’s head.

Cleaning the Mask

This mask is disposable and should be discarded if heavily soiled. If lightly soiled, the mask may be cleaned by wiping with a 70% v/v isopropyl alcohol swab. Do not disassemble the mask.

CAUTIONS

• Do not use solutions containing bleach, chlorine, aromatics, moisturisers,

antibacterial agents, or scented oils to clean any part of the system or air tubing. These solutions may cause damage and reduce the life of the product.

• Do not expose any part of the system or tubing to direct sunlight as it may

deteriorate.

• If any visible deterioration of a component is apparent (cracking, tears, etc),

replace the mask.

Technical Specifications

When determining ventilator settings, and in particular the tidal volume for volume cycled ventilators, make appropriate allowances for mask dead space and leak.

Unintentional Mask Leak

The Unintentional Mask Leak comprises leak between the cushion-frame and elbow-frame interfaces.

Pressure (cm H Maximum leak (L/min): 6 12

Dead Space

Dead space is the empty volume of the mask up to the elbow. The dead space of the mask varies according to cushion sizes but is less than 342 mL.

Standards

CE designation in accordance with EC directive 93/42/EEC, class IIa. EN ISO 14971, ISO 5356-1, ISO 594-1, ISO 10993-1 and ISO 13485.

Operating Pressure

0 to 40 cm H2O

Resistance

Drop in pressure measured: at 50 L/min: 0.4 cm H2O, at 100 L/min: 1.2 cm H2O

Dimensions

H = 158 mm, W = 230 mm and D = 105 mm (Medium)

Environmental Conditions

Operating temperature: +5°C to +40°C Operating humidity: 10%–95% relative humidity non-condensing Storage and transport: -20°C to +60°C Storage and transport humidity: 10%–95% relative humidity non-condensing

Disposal

This mask contains no hazardous materials and may be disposed of in accordance with local environmental regulations.

0): 4–20 20–30

English

Symbols

Caution, consult accompanying documents

REF

Part number Temperature limitation

Humidity limitation Does not contain latex

LOT

Lot number

Manufacturer Single use

Small Medium Large NV: Non-vented

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.

Ordering Information

REF Item

60735 ResMed Hospital NV Full Face Mask, Small

60736 ResMed Hospital NV Full Face Mask, Medium

60737 ResMed Hospital NV Full Face Mask, Large

60711 Headgear (10 pk.)

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