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Hospital Mask

NON-VENTED 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.

60834r1.book  Page 1  Friday, June 8, 2007  2:02 PM

Summary of Contents for 60735

Page 1: ...ixed 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...

Page 2: ...de 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...

Page 3: ...frame and elbow frame interfaces 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 C...

Page 4: ...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 REF Item 60735...

Page 5: ...5 Hospital Mask ResMed ResMed 30 7 ResMed 22 ISO5356 1...

Page 6: ...6 ResMed 1 2 3 a b 4 5 70...

Page 7: ...ISO 14971 ISO 5356 1 ISO 594 1 ISO 10993 1 ISO 13485 0 40 cm H2O 50 0 4 cm H2O 100 1 2 cm H2O 158 230 105 5 C 40 C 10 95 20 C 60 C 10 95 cm H20 4 20 20 30 6 12 NV 60735 ResMed 60736 ResMed 60737 ResMe...

Page 8: ...8...

Page 9: ...9 Hospital Mask ResMed ResMed 30 7 ResMed 22 ISO5356 1 ResMed...

Page 10: ...10 1 2 3 a b 4 5 70 cm H20 4 20 20 30 6 12...

Page 11: ...2 EEC IIa CE EN ISO 14971 ISO 5356 1 ISO 594 1 ISO 10993 1 ISO 13485 0 40 cm H2O 50 0 4 cm H2O 100 1 2 cm H2O 158 230 105 5 40 10 95 20 60 10 95 NV 60735 ResMed 60736 ResMed 60737 ResMed 60711 10 LOT...

Page 12: ...and France Germany Hong Kong India Japan Malaysia Netherlands New Zealand Norway Singapore Spain Sweden Switzerland UK USA see www resmed com for contact details ResMed Hospital NV Full Face Mask Prot...

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