NV Elbow F20 - Medical accessory ResMed - Free user manual and instructions

USER MANUAL NV Elbow F20 ResMed

ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia See ResMed.com for other ResMed locations worldwide. AirFit, AirTouch and Astral are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip ©2021ResMed. 638299/2 2021-11English 1

Non-vented elbow ENGLISH The NV (Non-Vented) Elbow F20 accessory replaces the existing vented elbow in the AirFit™ F20 / AirTouch™ F20 mask and converts it to a non-vented mask system. Intended use The NV Elbow F20 converts the AirFit F20 and AirTouch F20 Vented Masks into Non-Vented masks for the purpose of delivering non-invasive positive pressure ventilation. The converted Non-Vented mask systems are to be used with ventilators that have adequate alarms and safety systems for ventilator failure, to administer continuous or intermittent ventilatory support. The NV Elbow F20 (when used with the converted Non-Vented AirFit F20 and Non-Vented AirTouch F20 masks) is:

• to be used by patients weighing more than 30 kg

• 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 Refer to the AirFit F20 / AirTouch F20 User Guide for general warnings related to using the mask. The following additional warnings relate to the use of the NV Elbow F20.

• This mask, fitted with the NV elbow, is to be used with patients requiring non-life support ventilatory assistance.

• The NV elbow F20 is to be used with ResMed AirFit F20 and AirTouch F20 mask systems only.

• This mask, fitted with the NV elbow, must be used with an external exhalation device. This mask must be fitted, and therapy maintained by trained medical staff. Failure to monitor the patient may result in loss of therapy, serious injury or death.

• This mask, fitted with the NV elbow, must be used under qualified supervision for users who are unable to remove the mask by themselves or are at risk of not responding to an issue. This mask is not suitable for individuals predisposed to aspiration. Failure to use under supervision in these circumstances may result in serious injury or death.

• This mask, fitted with the NV elbow, does not contain an exhaust feature or anti-asphyxia valve (AAV). This mask must be used with a non-invasive ventilation (NIV) circuit with an exhaust system or a Positive Pressure Ventilator with an exhalation valve. When the ventilator is functioning properly, the exhalation valve allows exhaled air to escape to ambient. When the ventilator is not operating, exhaled air may be re-breathed. Re- breathing exhaled air can, in some circumstances, lead to suffocation and/or injury.2

• The mask, fitted with the NV elbow, should not be used unless the device is turned on.

• Follow all precautions when using supplemental oxygen.

• Oxygen flow must be turned off when the ventilator device is not operating (if used), so that unused oxygen does not accumulate within the device enclosure and create a risk of fire.

• 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.

• At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration varies, depending on the pressure settings, patient breathing pattern, mask, point of application and leak rate.

• If any visible deterioration of NV elbow is apparent (cracking, crazing, tears etc), the component should be discarded and replaced.

• The technical specifications of the mask fitted with the NV elbow are provided to check that the mask is compatible with the ventilator device. If used outside specification or if used with incompatible devices optimum therapy may not be achieved.

• Discontinue using this mask if the patient has ANY adverse reaction to the use of the mask, fitted with the NV elbow, and consult a physician.

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

• Refer to the appropriate ventilator device manual for details on settings and operational information.

• Avoid connecting flexible 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.

• Always follow cleaning instructions. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours.

• As part of good hygiene, always follow cleaning instructions to prevent the growth of germs.

Remove all packaging before use.

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. ResMed has tinted the NV Elbow F20 blue to identify it as a non-vented accessory. The elbow has a standard female 22mm tapered fitting for external connection to the ventilator. Refer to the Technical specifications section in this user guide for information about mask leak (pressure-flow), deadspace and resistance. Assembly

1. If the vented elbow is still assembled to the mask, squeeze the side buttons and pull the elbow

away from the frame.

2. Attach the NV Elbow F20 to the mask by pushing the elbow into the frame, ensuring it clicks in

and is firmly secured.English 3

Disassembly Remove the NV Elbow F20 from the mask by squeezing the top and bottom side buttons and pulling away from the frame. Cleaning Daily/After each use: Refer to the AirFit F20 / AirTouch F20 User Guide. The cleaning instructions for the elbow apply to the NV Elbow F20. Discard if heavily soiled. Reprocessing between patients Reprocess this component when using between patients. Refer to the AirFit F20 / AirTouch F20 reprocessing instructions available on ResMed.com/downloads/masks. Technical specifications The following specifications apply to the NV Elbow F20 with the AirFit F20 / AirTouch F20 mask. Compatible devices Astral™ Deadspace Empty volume of the mask up to the end of the elbow. The mask deadspace varies according to cushion size. AirFit - Small: 206 mL, Medium: 226 mL, Large: 247 mL AirTouch - Small: 227 mL Medium: 251 mL Large: 288 mL Therapy pressure 3 to 40 cm H

O: < 6 L/min Resistance Drop in pressure measured (nominal) at 50 L/min: 0.2 cm H

at 100 L/min: 0.6 cm H

Materials Polycarbonate Environmental conditions, mask gross dimensions and service life: Refer to the AirFit F20 / AirTouch F20 User Guide.

Storage and disposal Refer to the AirFit F20 / AirTouch F20 User Guide for storage and disposal. Symbols The following symbols may appear on your product or packaging. Non-vented mask Medical device. Importer. Not made with natural rubber latex 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. See symbols glossary at ResMed.com/symbols. Warranty Refer to the AirFit F20 / AirTouch F20 User Guide for warranty information. Further information For the most up to date information and instructions in other languages, go to ResMed.com/downloads/masks.Deutsch 1

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ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia See ResMed.com for other ResMed locations worldwide. AirFit, AirTouch and Astral are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip ©2021ResMed. 638299/2 2021-11