F&P AIRVO 2 User manual

Tube and Chamber Kit
900PT563
(with nebulizer adapter)
AIRVO
TM
2
SYM-1 REV T ENGLISH A4_condensed
Manufacturer Fisher&Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, Auckland 2013, PO Box 14348 Panmure, Auckland 1741, New Zealand Tel:+6495740100 Fax:+6495740158
Email:inf[email protected] Web: www.fphcare.com Importer/ Distributor Australia
(Sponsor) Fisher&Paykel Healthcare Pty Ltd, 19-31 King Street, Nunawading, Melbourne, Victoria 3131. Tel:+61398714900
Fax:+61398714998 AustriaTel:0800293123 Fax:0800293122 Benelux Tel:+31402163555 Fax:+31402163554 Brazil Fisher&Paykel do Brasil, Rua Sampaio Viana, 277 cj 21, Paraíso, 04004-
000, São Paulo–SP, Brazil Tel:+551125487002 China 代理人/售后服务机构:费雪派克医疗保健（广州）有限公司, 广州高新技术产业开发区科学城科丰路31号G12栋301号电话: +862032053486 传真
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Fisher&PaykelHealthcareSAS, 10 Av. du Québec, Bât F5, BP512,
Villebon-sur-Yvette,91946 Courtaboeuf Cedex, France Tel:+33164465201 Fax:+33164465221 Email:[email protected] Germany
Fisher&Paykel Healthcare GmbH & Co. KG, Deutschland, Österreich, Schweiz,
Wiesenstrasse49, D73614Schorndorf, Germany Tel:+497181985990 Fax:+4971819859966 HongKongTel:+85221160032 Fax:+85221160085 India Tel:+918023096400 Ireland
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İthalatçı Firma: Fisher Paykel Sağlık Ürünleri Ticaret Limited Şirketi, İletişim Bilgileri: Ostim Mahallesi 1249. Cadde No:6,
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Fisher&Paykel Healthcare Ltd, Unit 16, Cordwallis Park, Clivemont Road, Maidenhead, Berkshire SL67BU, UK
Tel:0800132189 Fax:+441628626146 USA/Canada Tel:18004463908 or +19494534000 Fax:+19494534001
F&P and Airvo are trademarks of Fisher & Paykel Healthcare Limited
REF 900639 REV A 2022-01 © 2022 Fisher & Paykel Healthcare Limited
9
10 11
12 13
87
5 6
43
1
2
2
14
OPT970
ONLY
USE WITHOUT A NEBULIZER USE WITH
A NEBULIZER
(albuterol
sulfate only)
Single
Use

Performance:
Albuterol sulphate (1 mg/mL, 2.5 mL) 10 L/min 20 L/min 30 L/min
Total delivered dose (μg)* 1362.9 - 2087.7 548.6 - 1938 383.3 - 1461.8
Total respirable dose (μg, 1-5μm)* 1035.9 - 1550.3 470.7 - 1428.2 387.9 - 837.3
Respirable fraction (%) 63 - 87.1 59.3 - 93.8 31.3 - 100
Coarse particle dose (μg, >4.7μm)* 206.6 - 528.2 0 - 507.8 0 - 531.9
Coarse particle fraction (>4.7μm) 14.9 - 27.6 4.7 - 32.4 0 - 47.2
Fine particle dose (μg, <4.7μm)* 1111.3 - 1604.5 519 - 1500.8 448.5 - 987.4
Fine particle fraction (<4.7μm) 72.4 - 85.1 67.6 - 95.4 52.8 - 100
Mass-Median Aerosol Diameter
(MMAD) (μm)*
2.67 - 2.94 2.41 - 3.05 2.08 - 3.00
Geometric Standard Deviation (GSD)
(μm)*
1.56 - 2.30 1.18 - 2.58 0.1 - 4.91
* 95% condence intervals
Testing carried out with one Aerogen Solo nebulizer, three sets of Airvo 2, 900PT563 kit and
OPT970 interface and three tests per set. Cascade impactor testing conducted at 15 L/
min using NGI.
WARNINGS:
• For single patient use only. Reuse may result in transmission of infectious substances.
Attempting to reprocess will result in degradation of materials and render the product
defective.
• Using the breathing tube for longer than the specified time can result in serious injury,
including infection.
• Do not use the auto-fill MR290 chamber if it has been dropped or been allowed to run dry as
this could lead to the chamber over-filling.
• Do not use the MR290 chamber if the water level rises above the maximum water level line as
this may lead to water entering the patient’s airway.
• Never operate the unit if the breathing tube has been damaged with holes, tears or kinks.
• Do not block the flow of air through the unit and breathing tube.
• California residents please be advised of the following, pursuant to Proposition 65: This
product contains chemicals known to the State of California to cause cancer, birth defects
and other reproductive harm. For more information, please visit: www.fphcare.com/prop65
To avoid burns:
• Do not allow the breathing tube to remain in direct contact with skin for prolonged periods
of time.
• Do not use in the presence of a naked flame, to avoid fires.
• Do not add heat to any part of the breathing tube e.g. covering with a blanket, or heating it in
an incubator or overhead heater for a neonate, as this could result in serious injury.
Cautions:
• Avoid product contact with chemicals, cleaning agents, or hand sanitizers.
• Use only USP sterile/distilled water for inhalation, or equivalent.
• Nebulized medications may be emitted into the surrounding area.
• Condensate containing nebulized medication may be present after use. Wear appropriate
personal protective equipment such as gloves.
To prevent condensation:
• Use in a room warmer than 18 °C (64 °F).
• Remove/minimize the impact of anything that may cool the heated breathing tube, e.g. a fan,
air conditioning, open window.
To manage excessive condensation:
• Place the Airvo below patient head height.
• Drain condensate back into the water chamber. At higher target flow settings it may be
necessary to first reduce the target flow setting to 30 L/min, to ensure that the condensate
drains safely and eectively.
• Disconnect the patient interface from the heated breathing tube.
• Lift the patient end of the heated breathing tube, allowing the condensate to run into the
water chamber.
Airvo™ Tube and Chamber Kit with nebulizer adapter - 900PT563
Indications for use - Airvo nebulizer adapter:
When used with a nebulizer:
The nebulizer adapter is a medical device accessory for single-patient use to facilitate
aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow
humidified breathing gases via tracheostomy patient interface. Intended for use by
healthcare professionals in hospitals or long-term care facilities.
When used without a nebulizer:
For use in hospitals and long-term care facilities, for the delivery of humidified
respiratory gases to patients via nasal, tracheostomy and mask interfaces.
System Specications:
Circuit Length: 1.8 m (6 ft) + interface.
Use WITHOUT a nebulizer
• If never used with a nebulizer, the 900PT563 kit must be disposed of after a maximum of 14
days’ use.
• Do not soak, wash or sterilize.
Setup:
• Airvo 2 humidifier (“Airvo”) on a flat surface.
• For use at flows from 2 to 60 L/min depending on the patient interface.
• OPT316/OPT318/OPT942/OPT944/OPT946/OPT1042/OPT1044/OPT1046 nasal interfaces
OR OPT970 tracheostomy interface OR OPT980 mask adapter interface
WARNING: Use of a non-approved accessory could impair performance or compromise
safety.
Steps 1 - 7:
Assemble and connect water chamber.
Step 8:
Ensure water level is rising but not going over the maximum water level.
Incorrect water level
Replace MR290 chamber
Correct water level in the
MR290 chamber
Use USP sterile/distilled water for inhalation, or equivalent.
Step 9:
Connect breathing tube to Airvo.
Step 10:
Make sure blue connector is fully located into place.
Step 11:
Connect breathing tube to patient interface once the system has warmed up. Position
breathing tube below patient interface so that condensate flows away from the patient.
Step 12:
Connect breathing tube clip to patient clothing or bedding. Note: connecting to patient
clothing may not be suitable for all patient groups.
Step 13:
In the absence of a nebulizer, make sure the nebulizer port plug is firmly in place.
• WARNING: Loss of therapy may occur if the nebulizer port plug is not in place.
Use WITH a nebulizer
• If used with a nebulizer at any time, the 900PT563 kit must be disposed of after a maximum
of 7 days’ use, whether nebulization is continuous or intermittent during this time.
• Do not soak, wash or sterilize.
CAUTION: Using the kit with a nebulizer for longer than 7 days may cause damage to the
kit, particularly the water chamber, and eventually the Airvo itself.
Setup:
WARNING: Nasal delivery of nebulized drugs for lung deposition is not approved by FDA.
WARNING: Use of a non-approved accessory could impair performance or compromise
safety.
• Airvo 2 humidifier (“Airvo”) on a flat surface.
• For use at flows from 10 to 30 L/min using the OPT970 patient interface.
• OPT970 tracheostomy interface
• Aerogen Solo nebulizer
Compatible medications:
•
• This kit is compatible with the following medications only:
• Albuterol sulfate
Refer to drug manufacturers’ instructions for correct usage and restrictions.
• WARNING: Do not nebulize the following medications, as they are incompatible with
Airvo and its consumables and may cause patient harm:
• Alcohol-based medications
• Significantly acidic or basic medications eg. epoprostenol (Flolan)
• Saline
Step 14 (Nebulizer use):
• Follow Steps 1-13.
• Remove the nebulizer port plug from the nebulizer port and connect the nebulizer in
its place.
CAUTIONS:
• Refer to the nebulizer manufacturer’s instructions for setup and usage information.
• Do not add oxygen or other gases through the nebulizer port or use a flow-
generating nebulizer (eg. jet nebulizer) as this will cause discrepancies in humidity,
flow and oxygen outputs.
• Ensure the Airvo is switched on with humidified gas flowing before the nebulizer is
used.
• The medication delivery eciency decreases as the Airvo flow increases. Ensure
that the patient receives adequate flow at all times when adjusting flow during
nebulization. Titrate medication delivery as required.
• Nebulized medications can form residue and cause cosmetic discoloration of the
breathing tube and chamber during normal operation.
• Nebulization may cause increased levels of condensate in the breathing tube and
chamber.
• Avoid skin contact with condensate as it may contain nebulized medication.