Actegy REVITIVE AEROSURE User manual

Model number: 3481AJ
PLEASE READ THE USER’S
MANUAL CAREFULLY BEFORE
USING THIS PRODUCT
USE ONLY AS DIRECTED
If symptoms persist, consult
your healthcare professional.
User’s Manual
You should also consult with
your healthcare professional
before use
•If you have an existing
medical condition
•If you are unsure about the
suitability of REVITIVE
Aerosure or the cause of
your symptoms

23
Contents
Parts and Controls ____________________________ 4
Introduction to REVITIVE Aerosure
Indications for use ________________________ 5
Important Safeguards
Contraindications _________________________ 6
Warnings ______________________________ 7-9
Instructions for use
Step 1: Before Use_______________________ 10
Step 2: Powering REVITIVE Aerosure____ 11-12
Step 2: Using REVITIVE Aerosure _______ 12-13
Step 3: Re-charging REVITIVE Aerosure ____ 15
Step 4: Cleaning and storing ___________ 16-19
Replacing the heads _____________________ 19
Environmental notice_________________________ 19
Technical Specifications_______________________ 20
Symbols_____________________________________ 21
Guarantee________________________________ 22-23

45
Parts and Controls
A
B
C
D
E
F
G
H
I
1
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
Charger Indicator
F
G
H
I
Introduction to REVITIVE Aerosure
INDICATIONS FOR USE
• Reduce breathlessness in healthy people, and
patients with asthma and COPD
• Produce beneficial effects in terms of increased
respiratory fitness in healthy people and in
patients with cystic fibrosis, COPD, and asthma
• Improve sputum clearance in patients with cystic
fibrosis and bronchiectasis; and
• Improve quality of life in patients with COPD,
bronchiectasis, asthma and cystic fibrosis.
Before operating REVITIVE 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.

67
• Use of this device does not replace the requirement
for any prescribed medication. Do not stop taking
your medication or change the dosage without first
consulting your doctor
• 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
REVITIVE Aerosure, stop using it immediately and
rest. If these symptoms persist, consult your doctor.
• Use of this device at excessive pressures may have
adverse effects.
• It is not advised to use this device in the case of users
with neurological disorders, end-stage respiratory
disease (incl. COPD and CF) unless under medical
supervision.
• In the Mucus Relief mode the mucus is dislodged from
the airways and lungs - you must then clear this mucus
through effective coughing. 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.
IMPORTANT SAFEGUARDS
• Are pregnant
• Have epilepsy
• Are coughing up blood (Active haemoptysis)
• Have acute sinusitis or an active nosebleed
• Have a broken rib until this is completely healed
•Have recently had thoracic (chest) or upper gastro-
intestinal tract (duodenum, stomach, oesophagus)
surgery or trauma until completely healed
•Currently have or previously had a collapsed lung
(Pneumothorax)
•Have abnormally high or low blood pressure, very slow
or very fast heart rate (Haemodynamic instability
including severe right-sided heart failure with
hypotension)
•Currently have a blood clot in the blood vessels in the
lungs (Current Pulmonary embolism)
•Have enlarged veins in the oesophagus (Oesophageal
varices)
• Had recent dental, head, neck, ear, nose & throat
surgery or trauma until completely healed
• Have abnormally high pressure in the skull and brain
(Raised intracranial pressure)
• You are experiencing a sudden worsening of
breathlessness. For example (but not limited to)
exacerbations of asthma.
Do not use if you (contraindications): Warnings

89
• Swallowing air should be avoided as this may lead to
an increased likelihood of vomiting and aspiration
• If you experience a sore or dry throat, stop using the
device until these symptoms go away or try drinking
some water. If symptoms persist, consult your doctor.
• 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 16].
• 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.
• 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.
• 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.
IMPORTANT SAFEGUARDS
Warnings (continued)
SAVE THESE INSTRUCTIONS

10 11
REVITIVE 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 16].
• 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 16].
Please ensure that all of the following checks are
carried out before each use of REVITIVE Aerosure.
IMPORTANT: REVITIVE Aerosure will require a full
charge prior to first use, approximately 12 hours.
Instructions for use
STEP 1 :
BEFORE USE
STEP 2 :
POWERING REVITIVE AEROSURE
• The mode indicator lights (G) (H) will flash repeatedly in
sequence to indicate the unit is charging [see picture 3].
The charger Plug is intended as the means of
isolation from the supply mains. Do not position
the plug or charger in a position where it is difficult
to disconnect from the supply mains.
3
• Plug the charger (D) into an electrical
outlet.
• Place the handle unit (C) onto the charger
base [see picture 2].
2

12 13
• REVITIVE Aerosure is charging. 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.
• The product will require a full charge prior to first use:
approximately 12 hours.
• A full charge enables approximately one and a half
hours of use.
Instructions for use
STEP 3 :
USING REVITIVE AEROSURE
4
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.
5
Turn the product on by pressing and
holding the Power Button for 2
seconds [see picture 5].
The Mucus relief Mode indicator will
now be lit [see picture 6].
• You will also hear the motor and
Valve Head begin to rotate.
• Place the Mouthpiece (A) in your
mouth.
• Breathe 15-20 times through the Mouthpiece (A) 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 REVITIVE Aerosure from
your mouth before coughing to clear any mucus. Do not
attempt to clear loosened mucus by coughing through
the Mouthpiece (A).
MUCUS RELIEF MODE:
• Breathe through REVITIVE Aerosure according to the
instructions on the next two pages depending on the
Mode you wish to use.
OFF MODE 1 MODE 2
6

14 15
Turn the product on by pressing and holding the Power
Button for 2 seconds [see picture 5).
• 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 7].
• Place the Mouthpiece (A) in your
mouth.
• Breathe as hard as you are
comfortably able to, through the
Mouthpiece (A) for five minutes,
2-3 times per 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.
BREATHE EASIER MODE:
Instructions for use
STEP 4 :
RE-CHARGING REVITIVE AEROSURE
8
• If the rechargeable battery is low the
red low charge indicator light (I) will
flash when the product is in use [see
picture 8].Stop using the product and
put it on charge.
• A full charge will take approximately twelve hours.
• If the rechargeable battery is empty the motor will stop
and the REVITIVE Aerosure will not respond when the
power button is pressed and will need recharging.
OFF MODE 1 MODE 2
7

16 17
10
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.
DISINFECTING THE HEAD
Prepare an appropriate disinfectant solution in
accordance with disinfectant manufacturer’s instructions.
The disinfectant solution should be suitable for use on
equipment that comes into contact with the mouth1.
Remove the mouthpiece (A) and Valve Head (B) from
handle (C) and place both the mouthpiece and Valve Head
in disinfectant solution. Immerse Valve Head fully and shake
it gently to remove any air bubbles [see picture 9].
911
Instructions for use
STEP 5 :
CLEANING REVITIVE AEROSURE
Leave Valve Head to soak in solution for the minimum
time specified by the disinfectant solution instructions [see
picture 10].
After the specified soak time has passed remove the
mouthpiece and Valve Head from solution, rinse with clean
water and drain. Allow to air dry for at least 2 hours – to
ensure head drains adequately ensure that it is standing on
the rear vent opening [see picture 11].
1NOTE: The Valve Head has been tested using disinfectant
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.

18 19
1312 14
Remove the mouthpiece (A) from the Valve Head (B) and
rinse under warm running water (approximately 40oC) [see
picture 12].
With the Valve Head attached to the handle (C) and the
REVITIVE 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 13].
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 14]. Shake
the Valve Head and mouthpiece 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 15].
The handle and charger (unplugged from mains power
supply) should be cleaned as necessary with a damp cloth
only. IMPORTANT: No part of REVITIVE Aerosure is suitable
for dishwasher use.
15
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.
CLEANING THE HEAD
Instructions for use Instructions for use
Replacement Valve Heads are available for your
REVITIVE Aerosure and it is recommended that
you replace the Valve Head at least once every
6 months.
Replacement heads are available through your local
REVITIVE Aerosure retailer or distributor, or from the
REVITIVE website.
Please ask for the following part reference.
REVITIVE Aerosure Replacement Head Item Ref 1377.
STORING REVITIVE AEROSURE
REPLACEMENT HEADS

20 21
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
REVITIVE Aerosure in a well-ventilated room.
Materials have been selected and tested to ensure no irritation or allergic
reaction in accordance with biocompatibility standards.
Technical Specifications
Product Model 3481AJ
Software version
(shown by V#.#) See underside of handle.
Charging Voltage 110v-240v
Power supply rating 30mA – 50mA
Battery & Battery Life Ni-MH / 500 cycles
Fuse T500mAH250V
Operating Environment Temperature 0°C to 40°C Humidity 25 to 85% RH
Atmospheric pressure 86kPa - 106kPa
Storage and
Transportation Environment 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
Symbols
Contraindications. This describes situations
where you should not use the REVITIVE Aerosure
Warnings and cautions. Make sure you
understand these before using the REVITIVE
Aerosure
Type BF medical electrical equipment
Parts A, B and C (ref picture 1) are applied parts.
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 20).
Indicates the item model reference number
LOT
NiMH
REF
-18°C
50°C
25%
85%
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).

22 23
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 REVITIVE 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 REVITIVE 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.
Your International Two Year Warranty

24
Legal Manufacturer
Actegy Ltd.
Reflex, Cain Road
Bracknell, Berkshire, RG12 1HL
United Kingdom.
Country Distributors:
International and UK:
Tel: [phone]
Ireland
Tel: [phone]
Copyright © 2018 Actegy Ltd. All rights reserved. ACTEGY™, REVITIVE®
and AEROSURE™ are registered trademarks of Actegy Ltd. The REVITIVE
AEROSURE™ product is a proprietary design and is protected by applicable
design laws.
AW 3465 IFU01 14951442 P.D 01.2018.