Aerosure Medic User manual

USER’S MANUAL

Please read the user’s

manual carefully before

using this product.

Use only as directed. If

symptoms persist, consult

your healthcare professional.

Model:

AEROSURE MEDIC

Before operating AEROSURE, please read these instructions

in full and save this manual for future reference. Please contact

the manufacturer if you require further advice for using or

maintaining your device or experience any unexpected issues.

INTENDED USE

AEROSURE is intended to:

• Reduce shortness of breath and relieve breathlessness with

regular use.

• Increase respiratory ﬁtness with regular use.

• Improve mucus and phlegm clearance.

Do not use AEROSURE if you suffer from:

• Epilepsy

•Current or previous Pneumothorax (collapsed lung)

•Haemodynamic instability including severe right-sided

heart failure with hypotension (abnormally high or low blood

pressure, very slow or very fast heart rate)

•Current Pulmonary embolism (blood clot in the blood vessels in the lungs)

•Oesophageal varices (enlarged veins in the oesophagus)

•Recent thoracic or upper gastro-intestinal tract surgery or

trauma until completely healed. (chest, duodenum, stomach or oesophagus)

•Recent dental, head, neck, ear, nose & throat surgery or

trauma until completely healed

•Broken rib until this is completely healed

•Acute sinusitis or nosebleed

•Active haemoptysis (coughing up blood)

•Raised intracranial pressure (abnormally high pressure in the skull and brain)

•If you are pregnant

For further warnings refer to pages 7 and 8.

CONTRAINDICATIONS

WELCOME TO AEROSURE!

If you are unsure of the suitability of the Aerosure for you or

are unsure about the cause of your symptoms, you should

consult with your healthcare professional before use.

2

CONTENTS

3

Welcome to AEROSURE______________________________________ 2

Contents ________________________________________________________ 3

Quick Reference Guide:

•Product Diagram ______________________________________ 4

•Connecting and Charging ____________________________ 4

•Holding your AEROSURE_____________________________ 5

•Mode Description ___________________________________5-6

Warnings ______________________________________________________7-8

Before use_______________________________________________________ 8

Charging_________________________________________________________ 9

Cleaning recommendations__________________________________10

Storage:

• Environmental notice (Battery)______________________11

• Technical speciﬁcations ______________________________11

Symbols_________________________________________________________12

Guarantee ______________________________________________________13

Warranty _________________________________________ 19-20

QUICK REFERENCE GUIDE

A

B

C

D

E

F

G

H

I

1

*Indicates an applied part.

A

B

C

D

E

MOUTHPIECE*

VALVE HEAD*

HANDLE*

CHARGER

VENT

ON/OFF BUTTON AND MODE

SELECTION BUTTON

MUCUS RELIEF MODE INDICATOR

BREATHE EASIER MODE INDICATOR

CHARGE INDICATOR

F

G

H

I

CONNECTING AND CHARGING

2

• Plug the charger (D) into an electrical outlet.

• Place the handle unit (C) onto the charger base.

• The mode indicator lights (G) (H) will ﬂash

repeatedly in sequence to indicate the unit is

charging.

• The product will require a full charge prior to

ﬁrst use: approximately 12 hours.

Before operating AEROSURE MEDIC please read the user’s

manual in full.

4

QUICK REFERENCE GUIDE

4

Turn the product on by pressing and holding

the Power Button for 2 seconds (see picture 4).

The Mucus relief Mode indicator will now be lit

(see picture 5).

• You will also hear the motor and valve head

begin to rotate.

• Place the product in your mouth.

• Breathe 15-20 times through the Valve Head (B) and then remove

the device from your mouth and huff and/or cough to aid the

clearance of mucus normally.

• It is important that you remove AEROSURE from your mouth

before coughing to clear any mucus. Do not attempt to clear

loosened mucus by coughing through the Valve Head (B).

MUCUS RELIEF MODE:

5

HOLDING YOUR AEROSURE

3

IMPORTANT: Never obstruct the vent (E).

• Hold the product with your hand cupped

around the lower section of the handle (C)

with the buttons and mouthpiece facing

towards you.

• Place the mouthpiece (A) in your mouth so that

your lips cover the outer shield to make a seal.

• Breathe through AEROSURE according to

the appropriate Mode (see picture 5).

QUICK REFERENCE GUIDE

5MUCUS RELIEF

MODE

BREATHE EASIER

MODE

POWER OFF

BREATHE EASIER MODE:

Turn the product on by pressing and holding the Power Button for 2

seconds (see picture 4).

• Press the power button once more.

• You will also hear the motor and valve head begin to rotate.

• The Breathe Easier Mode indicator will now be lit (see picture 5).

• Place the product in your mouth.

• Breathe through the Valve Head for ﬁve minutes, twice a day.

• Once your session is complete, turn off the product by pressing

the Power Button (F) to cycle through the modes until the motor

stops. Note: There is no separate OFF light. The product is off

when none of the indicators are lit.

6

• For hygiene reasons, this product is intended for a single user only.

Do not share the valve head or mouthpiece with any other users.

• If you feel light headed, dizzy or pain whilst using AEROSURE, stop

using it immediately and rest. If these symptoms persist, consult

your doctor.

• In the presence of an ineffective cough, additional assisted coughing

devices or techniques may be required and advice sought from a

qualiﬁed medical practitioner.

• Use this product only for its intended use as described in this manual.

• Do not use attachments which are not recommended by

the manufacturer.

• This product is not intended for use by children or persons with

reduced physical, sensory or mental capabilities, unless they are

supervised by a person responsible for their safety.

• Keep the product out of the reach of children.

• Clean the valve head and mouthpiece prior to ﬁrst use (see page 10).

• Always unplug before cleaning.

• Do not submerge the handle or charger in water or other liquid.

• Do not place or store the charger where it can fall or be pulled

into water.

WARNINGS

7

AEROSURE has been designed with home users in mind.

Please consult the contraindications and warnings prior to use.

• Ensure that both the valve head (B) and mouthpiece (A) are

securely in place.

• Ensure the airway between the mouthpiece (A) and the vent (E) is

both clean and dry. If not, please clean the product (see page 10).

• Ensure that there are no obstructions of any kind in the airway

between the mouthpiece (A) and the vent (E). If any obstruction is

found, please clean the product (see page 10).

Please ensure that ALL of the following checks are

carried out before each use of AEROSURE.

BEFORE USE

WARNINGS

• Do not reach for a charger that has fallen into water.

Unplug immediately.

• Do not touch the power plug with wet hands. This can cause an

electric shock.

• When unplugging, always hold the power plug instead of the cord.

• Do not use if the adaptor or cord is damaged. If the cord is damaged,

contact your local distributor. The power cord is not intended for

repair by service personnel. If damaged the whole charger unit will

require replacement.

• Do not modify, repair or disassemble any part of the product.

This may cause ﬁre, electric shock or injury. Consult your dealer or

contact your local distributor for information and assistance.

• Do not insert any object into the valve head or into any opening

of the product or charger.

• Ensure no particles or objects are lodged in the valve head and

obstructing airﬂow.

8

7

6

• A full charge enables approximately one and a

half hours of use.

• If the rechargeable battery is low the red low

charge indicator light (I) will ﬂash when the

product is in use [see picture 7].Stop using the

product and put it on charge.

• If the rechargeable battery is empty the motor will

stop and the AEROSURE will not respond when the

power button is pressed and will need recharging.

AEROSURE is charging [see picture 6]. Once fully charged, the indicator

lights will simultaneously ﬂash on and off for ten minutes. After this period

the product will turn off automatically to preserve battery life and no

indicator lights will be lit.

• A full charge will take approximately twelve hours.

CHARGING

The charger Plug is intended as the means of isolation from one

supply mains.Do not position the plug or charger in a position

where it is difﬁcult to disconnect from the supply mains.

Replacement valve heads are available for your AEROSURE and it is

recommended that you replace the valve head at least once every

6 months.

Replacement heads are available through your local AEROSURE retailer

or distributor.

Please ask for the following part reference.

AEROSURE Medic Replacement Head Item Ref 1377.

REPLACEMENT HEADS

9

CLEANING RECOMMENDATIONS

9

810 11

1NOTE: The Valve Head has been tested using cleaning solutions with the following

active ingredient:

• Sodium hypochlorite (CAS: 7681-52-9) 2% w/w diluted and used in line with the

manufacturer’s directions.

• Sodium dichloroisocyanurate (CAS: 2893-78-9) 19.5% w/w diluted and used in line

with the manufacturer’s directions.

It is recommended that after every use the mouthpiece (A) and valve head

(B) are cleaned according to the instructions below.

It is recommended that users who are currently suffering from a chronic

respiratory disease (e.g. cystic ﬁbrosis, chronic obstructive pulmonary

disease) or are prone to recurrent chest infections or have an immune

deﬁciency should soak the mouthpiece (A) and valve head (B) in a mild

disinfectant solution after every use.

It is recommended that other users should soak the mouthpiece (A) and

valve head (B) in a mild disinfectant solution at least once a week.

The disinfectant solution should be suitable for use on equipment that comes

into contact with the mouth1and should be used in accordance with the

manufacturer’s directions. After disinfection the mouthpiece (A) and valve head

(B) should be cleaned in accordance with the directions below.

Remove the mouthpiece (A) from the valve head (B) and rinse under warm

running water (approximately 40oC) [see picture 8].

With the valve head attached to the handle (C) and the AEROSURE switched

on rinse the valve head under warm running water to ensure that the valve head

and its internal components are completely cleaned [see picture 9]. Take care

not to put the handle under the running water.

Remove from under the water and with the motor still running allow the valve

head to drain. Switch off the product and remove the valve head [see picture

10]. Shake the valve head and mouth piece to remove any remaining water and

allow both to dry fully before reassembling. To help drain any residual water

from the valve head stand it upright on the vent opening (E) while drying [see

picture 11].

The handle and charger (unplugged from mains power supply) should

be cleaned as necessary with a damp cloth only. IMPORTANT: No part of

AEROSURE is suitable for dishwasher use.

10

This product contains rechargeable batteries. In the interest of

protecting the environment, please do not dispose of the product

in the household waste at the end of its useful life. Disposal can take

place by either returning to your local distributor or at approved

recycling or disposal locations in accordance with local regulations.

ENVIRONMENTAL NOTICE (Battery)

Store in a dry, dust free location in temperatures between -18°C and

50°C and 25% to 85% relative humidity. It is recommended that you

store your product in the case provided when it is not being

used or charged.

STORAGE

TECHNICAL SPECIFICATION

Product Model

Software version (shown by V#.#)

Charging Voltage

Power supply rating

Battery & Battery Life

Fuse

Operating Environment

Storage and

Transportation Environment

AEROSURE Medic

See underside of handle.

110v-240v

30mA – 50mA

Ni-MH / 500 cycles

T500mAH250V

Temperature 0°C to 40°C

Humidity 25 to 85% RH

Atomspheric pressure 86kPa - 106kPa

Temperature -18°C to 50°C

Humidity 25% to 85%RH

Protection rating against ingress

of water or particulate matter.

IP45 (protected against small tools and

wires >1mm and low pressure water jets)

Protection against electric shock Internally powered ME equipment. Class

II (for charging unit).Type BF applied part

(valve head, handle and mouthpiece).

Mode of operation Continuous

NOTE: Not intended to be sterilised. Not suitable for use in an OXYGEN RICH ENVIRONMENT -

If you are on oxygen we recommend you use your AEROSURE in a well ventilated room.

Materials have been selected and tested to ensure no irritation or allergic reaction in accordance

with biocompatibility standards.

11

Medical electrical equipment needs special precautions regarding EMC for installation and use

according to the EMC information provided in this user manual.

Wireless communication equipment such as wireless home network devices, mobile phones,

cordless telephones and their base stations or walkie-talkies can affect this equipment and

should be kept at least a distance of 3.3m away from the equipment.

(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone

with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m).

SYMBOLS

Contraindications

This describes situations where

you should not use the AEROSURE™

LOT

-18°C

50°C

25%

85%

Warnings and cautions

Make sure you understand these

before using the AEROSURE™

Type BF medical electrical equipment

Medical electrical equipment double insulated

Complies with European Medical

Devices Directive (93/42/EEC)

The Waste Electrical and Electronic Equipment Directive

(WEEE Directive). At the end of the product lifecycle, do not

throw this product into normal household waste, but take it

to a collection point for the recycling of electronic equipment

Legal manufacturer of the device

Consult instructions for use

Indicates the LOT number

Humidity and temperature limit

for storage and transportation

Indicates presence of NiMH battery.

(See page 12).

NiMH

Indicates the item model reference number

REF

12

YOUR INTERNATIONAL TWO YEAR GUARANTEE

It is important to retain the retailer’s

receipt as proof of purchase; we suggest

you staple your receipt to this manual for

future reference.

In the unlikely event of your product

proving to be faulty within 28 days of

purchase it should be returned to the

place where you bought it. If a fault

develops after this period we grant a 2

year limited guarantee on the product

commencing on the date of purchase.

Within the guarantee period we will

eliminate, free of charge, any defects

in the product resulting from faults in

materials or workmanship, either by

repairing or replacing the complete

product as we may choose.

To obtain service within the guarantee

period contact your local distributor. You

will be asked to return the product (in

secure, adequate packaging) together

with a copy of proof of purchase. Subject

to the exclusions set out below (see

Exclusions) the faulty product will then be

repaired or replaced within 7 working days

of receipt. The guarantee extends to every

country where this product is supplied by

Actegy or its appointed distributor.

If, for any reason, the product is replaced

during the 2 year guarantee period,

the guarantee on the new item will be

calculated from the original purchase date.

EXCLUSIONS

Actegy Ltd., manufacturer of AEROSURE,

shall not be liable to replace or repair the

goods under the terms of the

guarantee where:

• Damage or the fault is due to

improper use, normal wear or use

(especially regarding the valve head),

accidental use, misuse, negligent use

or use contrary to the manufacturer’s

recommendations or where the fault

has been caused by power surges or

damage carried out in transit

• Defects have a negligible effect on the

value or operation of the appliance.

• The device has been used on a voltage

supply other than that stated on the

product or used with a power adapter

other than the one supplied with the

product.

• Repairs have been attempted or

undertaken by a person other than our

service staff (or an authorised dealer)

or if original AEROSURE parts are

not used

• The device has been used for hire

purposes or non-domestic use.

• The device is second hand

Actegy Ltd are not liable to carry out

any type of servicing work under the

guarantee

This guarantee does not confer any

rights other than those expressly set out

above and does not cover any claims

for consequential loss or damage. This

guarantee is offered as an additional

beneﬁt and does not affect your statutory

rights as a consumer.

GUARANTEE

13

AUSTRALIAN WARRANTY

This device is guaranteed for 2 years

against faulty material, components

and workmanship.

This warranty is in addition and does

not affect your statutory rights.

Proof of purchase must be produced

for any warranty beneﬁt.

In the unlikely event of any device

proving to be faulty, securely pack

and return the item to the place of

purchase accompanied by the original

receipt or invoice.

Our goods come with guarantees

that cannot be excluded under the

Australian Consumer Law. You are

entitled to a replacement or refund for

a major failure and for compensation

for any other reasonably foreseeable

loss or damage. You are also entitled

to have the goods repaired or replaced

if the goods fail to be of acceptable

quality and the failure does not

amount to a major failure.

NOT COVERED BY THIS WARRANTY

(Australian only)

• If the device has not been used in

accordance with the manufacturers’

recommendations or Instructions.

• If the fault is deemed to be

caused by abuse, misuse, neglect,

modiﬁcations or improper use and

or care.

• Connection to incorrect voltage or

used with an incorrect power

adaptor to that stamped or

supplied with the product.

• Unauthorised repairs.

• Device used other than for

domestic purposes.

• Excluding accessories such

replacement heads.

• Freight and insurance costs.

If for any reason this item is replaced

during the 2 year guarantee period,

the guarantee on the new item will

be calculated from original purchase

date. Therefore it is vital to retain

your original receipt or invoice

to indicate the date of original

purchase.

Actegy Ltd’s policy is to continually

improve quality design and product

quality. The company therefore

reserves the right to change any

speciﬁcations or to carry out

modiﬁcations as deemed worthy at

any time.

GUARANTEE

14

NOTES

...................................................................................................................

NOTES

...................................................................................................................

NOTES

...................................................................................................................

Legal Manufacturer

Actegy Ltd.

8 Queens Square

Ascot Business Park

Lyndhurst Road, Ascot

Berkshire, SL5 9FE

United Kingdom

Country Distributors:

International and UK:

Tel: +44 (0)845 871 5989

Ireland

Tel: 01677 0164

Australian Sponsor

Actegy Pty Ltd.

Unit 4 / 1 Newspaper Place

Maroochydore

QLD, 4558

Tel: 1800 505 108

New Zealand Sponsor

Actegy Ltd.

24B Mooreﬁeld Road

Johnsonville

Wellington 6037

Tel: 0800 484 325

The AEROSURE™ product is a proprietary design and is protected by applicable design laws. AWv11.0. 10.2013.

The AEROSURE warranty plan

gives you peace of

mind, knowing our

customer care

team is only a

phone call away,

ready to help

you out in case

of any issues.

Peace of Mind - Your AEROSURE Warranty

We stand behind our product quality

which is why we offer a full

manufacturer’s warranty

To activate your warranty, register online

at www.warranty.actegy.com or complete the form

overleaf and mail it to your country location ofﬁce:

WARRANTY

Australia New Zealand United Kingdom

Actegy Ltd

24B Mooreﬁeld Road,

Johnsonville, Wellington

6037, New Zealand

Tel: 0800 484 325

Actegy Ltd

8 Queens Square, Ascot

Business Park, Lyndhurst Road,

Ascot, Berkshire, SL5 9FE

Tel: 0845 871 5989

Actegy Pty Ltd

Unit 4 / 1 Newspaper

Place, Maroochydore

QLD, 4558, Australia

Tel: 1800 505 108

19

Device Details

TV Newspaper / Magazine Pharmacy / Store Catalogue Online Friend

How did you ﬁnd out about your AEROSURE product?

All personal information provided by this card, such as email, contact name or address is done so on a voluntary basis. Actegy Ltd uses the

information explicitly only as stated, i.e. to register your device, to maintain your customer account and to send relevant mail or emails about

Actegy’s latest offers.

If you do not wish to receive any offers or information from Actegy Ltd by mail or phone, please tick here

If you would like to receive offers and information from Actegy Ltd by email, please tick here

From time to time Actegy Ltd may share your information with carefully selected third parties to bring you relevant offers and information.

If you do not wish to receive third party offers, please tick here

Privacy & Security – Collection and use of personal information:

WARRANTY REGISTRATION FORM

To activate your AEROSURE warranty, register online at

www.warranty.actegy.com or complete the form below

and mail it to your country location office (overleaf)

Mr/Mrs/Ms/Miss Initials Surname

House Number Address

Postal Code

Telephone number

Email Address

Sex: Male Female Year of Birth

Date of purchase Q. Please specify where you purchased

your device from?

Q. What is your main ailment or condition that you’re using the device for?

Your AEROSURE LOT Number

(Device LOT number can be found on the box and base of handle)

Customer Details

AEROSURE MEDIC User manual

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