PhysioAssist SIMEOX User manual

User manual
SIMEOX

1
1 INTRODUCTION TO SIMEOX ......................................... 3
1.1 About this user manual.......................................... 3
1.2 Signalling alerts, warnings and
recommendations ....................................................3
1.3 Intended use, indications....................................... 4
1.4 Contraindications..................................................... 4
1.5 Operating principles of SIMEOX........................... 5
1.5.1 Physical principle ............................................. 5
1.5.2 Principle of the medical device .................... 5
1.6 Contents of the packaging..................................... 6
2 GENERAL ALERTS, WARNINGS AND
RECOMMENDATIONS ..................................................... 7
2.1 Alerts........................................................................... 7
2.2 Warnings .................................................................... 9
2.3 Recommendations for use..................................10
3 DESCRIPTION OF SIMEOX............................................11
3.1 Components on the back panel.........................11
3.2 Components on the front panel ........................12
3.3 Components on the top panel and the
remote control ...................................................... 13
3.4 Control pad components.....................................14
3.5 Additional information on the SIMEOX user
interface ................................................................... 15
3.6 The expiratory kits ................................................16
4 USE OF SIMEOX..............................................................17
4.1 Composition and assembly of the expiratory kit..17
4.1.1 Composition of the expiratory kit..............17
4.1.2 Assembly of the expiratory kit....................18
4.1.3 Installing the wrist strap...............................19
4.2 Installing and setting up SIMEOX.......................20
4.2.1 Connecting the expiratory kit to SIMEOX.....20
4.3 Starting up SIMEOX ...............................................21
4.4 Pairing the remote control with SIMEOX ....................22
4.5 Operational check............................................................23
4.6 SIMEOX settings ...............................................................24
4.7 Conducting a therapy session ...........................25
4.8 Protection of the expiratory kit during the pause..26
4.9 Drying the tube .....................................................26
4.10 Shutting down SIMEOX .....................................27
Contents

5 CLEANING AND DISINFECTION...................................28
5.1 Cleaning and disinfecting SIMEOX.....................29
5.2 Cleaning and disinfecting the remote control ....... 29
5.3 Cleaning and disinfecting the accessories .....30
5.3.1 Wrist strap ........................................................30
5.3.2 Carrying bag.....................................................30
5.4 Cleaning and disinfecting the expiratory kits.... 31
5.4.1 Maintenance of the lter ..............................31
5.4.2 Maintenance of the tubes and mouthpieces...32
5.4.2.1 Expiratory kits TUB03_EU and TUB10_EU..32
5.4.2.2 Expiratory kits TUB25_EU....................................33
6 PREVENTIVE MAINTENANCE........................................34
7 CONTACTING US............................................................35
8 TRANSPORTING SIMEOX..............................................36
9 SYMBOLS USED ON THE LABELS
AND PACKAGING............................................................37
10 TECHNICAL SPECIFICATIONS....................................39
10.1 Compliance with standards and regulations ....39
10.2 Weight and dimensions .....................................39
10.3 Materials used that may come into contact
with the patient....................................................39
10.4 Operating life........................................................39
10.5 Compatible accessories.....................................40
10.5.1 Expiratory kits...............................................40
10.5.2 Accessories ...................................................40
10.6 Communications .................................................40
10.7 Stipulated environmental conditions .............40
10.8 Electrical characteristics ....................................40
10.8.1 Supply voltages............................................40
10.8.2 Applied parts (according to standard EN 60601-1) .... 40
11 ELECTROMAGNETIC COMPATIBILITY......................41
12 IN THE EVENT OF BREAKDOWN...............................43
13 WARRANTY CONDITIONS...........................................45
14 END-OF-LIFE, RECYCLING..........................................46
14.1 Expiratory kits.......................................................46
14.2 Remote control batteries ..................................46
14.3 SIMEOX...................................................................46

3
Introduction to Simeox
1
The purpose of this manual is to guide you in the safe use of SIMEOX.
This manual applies to devices with the references:
Simeox_H_EU to be used in Europe, operating on 230 VAC /50Hz.
Simeox_H_NA to be used in North America, operating on 120 VAC /60Hz.
Please read the instructions contained in this manual carefully and in full before using the device.
Keep this manual close to the equipment for subsequent use.
This user manual contains alerts, warnings and recommendations for use signalled by pictograms:
This pictogram is used to signal an alert.
An alert indicates a risk of injury for the patient or user.
This pictogram is used to signal a warning.
A warning indicates a risk of damaging SIMEOX, its expiratory kits or its accessories.
This pictogram is used to signal a recommendation.
A recommendation indicates an action that allows improved use of SIMEOX, its expiratory kits and its
accessories.
It is your responsibility to read this information and to comply with it, for the safety of the patient and the user.
1.1 About this user manual
1.2 Signalling alerts, warnings and recommendations

4
The SIMEOX from PHYSIO-ASSIST is a medical device
intended to be used by adults and children over 8 years
of age suering from a lung disease and who have
diculty in clearing bronchial secretions.
The SIMEOX device is indicated to help to liquefy and
transport secretions from the small bronchi of the distal
part of the lung to the large bronchi so that they can
then be removed by coughing.
The main conditions targeted by SIMEOX are cystic
brosis, Chronic Obstructive Pulmonary Disease (COPD),
bronchiectasis, primary ciliary dyskinesia.
SIMEOX is intended to be used in healthcare facilities, in
medical or paramedical practices, or at home.
In the context of home use, the patient is the intended
user of the device.
In the context of use in medical or paramedical
practices, or in a healthcare facility, the patient can also
be the user.
It is therefore recommended:
That a healthcare professional (doctor,
physiotherapist) be consulted beforehand to assure
you that the use of SIMEOX is not contraindicated in
your case.
That you be trained in the use of SIMEOX beforehand
in order to use it under optimal treatment conditions
There are no absolute contraindications to using
SIMEOX.
The relative contraindications to its use are the
following:
Pneumothorax that has not been treated or
drained,
Unstable cardiovascular pathologies (recent heart
attack, unstable angina, uncontrolled rhythm
disorders, unstable cardiac failure)
Massive haemoptysis
If you are in one of these situations, it is recommended
that you consult a healthcare professional before
using SIMEOX to assess whether the treatment is
appropriate for your situation (positive benet-risk).
SIMEOX should not cause any signicant discomfort
or pain in the patient: in the event of signicant pain
or discomfort, stop using SIMEOX immediately and
consult a healthcare professional.
In the event that a new unexpected symptom appears
or an existing symptom worsens, stop using SIMEOX
immediately and consult a healthcare professional.
1.3 Intended use, indications
1.4 Contraindications

5
1.5.1 Physical principle
SIMEOX is the result of ve years of research at PHYSIO-ASSIST studying the rheology of bronchial mucus under the
inuence of a vibratory pneumatic signal.
SIMEOX generates a succession of very short negative pressure pulses of a constant air volume at a frequency
similar to that of the vibrating cilia of the bronchial epithelium during relaxed expiration by the patient, spreading
a vibratory pneumatic signal throughout the whole bronchial tree which acts directly on mucus viscosity and
mobilisation.
Laboratory tests and digital simulations demonstrate that our technology exerts a signicant liquefying and draining
action on bronchial mucus.
1.5.2 Principle of the medical device
The patient uses SIMEOX during successive relaxed expirations.
SIMEOX sends a low frequency vibratory pneumatic signal throughout the whole patient’s bronchial tree, liquefying
the mucus and transporting it from the most distal parts of the peripheral airways to the central trunks to promote
its removal by the patient when they expectorate at the end of the session or after the sessions.
Between each very short negative pressure pulse generated by the vibratory pneumatic signal, the patient is
reconnected to atmospheric pressure. The patient is thus maintained largely at atmospheric pressure for most
of the expiration time (70%) in order to avoid any risk of bronchial collapse, the main obstacle to clearance of the
peripheral airways.
1.5 Operating principles of SIMEOX

6
SIMEOX is delivered in a box containing:
The SIMEOX device
A power cord adapted to the country of use
A carrying bag
A remote control containing a button battery
A wrist strap to be installed on the remote control
(see recommendations for using the wrist strap)
A user manual
The expiratory kits, essential for using SIMEOX, are supplied separately, in specic packaging.
Each expiratory kit is composed of a lter, a exible tube and mouthpieces.
1.6 Contents of the packaging
The plastic bags and small parts present a suocation risk: keep them out of the reach of children.

7
2.1 Alerts
Connect the device to a wall socket that supplies
the nominal voltage indicated on the machine.
In order to avoid any risk of arcing, connect the
power cord rstly to SIMEOX then to the wall
socket.
Likewise, once the device is switched o,
disconnect the cord from the wall socket before
disconnecting it from SIMEOX.
In order to avoid any risk of electrical discharge,
never plug in or unplug the device with wet
hands, do not use SIMEOX in damp rooms or in
bathrooms.
Monitor the device during use and stop using it in
the event of a malfunction.
Do not let a young patient use SIMEOX without
adult supervision.
The power cable and the tube of the expiratory
kits present a strangulation risk: keep them out of
the reach of children.
The mouthpiece and the remote control battery
present a suocation risk: keep them out of the
reach of children.
Only use the accessories and expiratory kits supplied
by PHYSIO-ASSIST.
SIMEOX is designed and manufactured to resist
spills of liquids falling vertically on the cover, but
as a safety measure, in the event of contact with
a liquid, immediately switch the device o and
disconnect it from the mains.
Never use SIMEOX if the plug or the power cord
is damaged, if the device presents an operating
fault or if it has been dropped, damaged or
immersed in water.
Never dismantle SIMEOX and do not try to
intervene if it breaks down: SIMEOX does not
contain any parts to be replaced by the user.
You are only responsible for replacing the remote
control batteries, as described in this manual.
Only approved personnel are authorised to
perform maintenance operations on SIMEOX.
Do not install SIMEOX against a wall; the main
switch must always remain accessible to switch
o SIMEOX in an emergency.
All modications to SIMEOX are prohibited.
The male mains plug can be used as a means of
separating SIMEOX from the electricity grid.
The SIMEOX mouthpiece is intended to make
contact with the patient’s mouth.
Although the materials used are biocompatible, in
the event of irritation, tingling or allergies, stop using
SIMEOX immediately and consult a specialist.
General alerts, warnings and
recommendations
2

8
Before cleaning, always switch o the device and
unplug it from the wall socket.
When cleaning or disinfecting expiratory kits, make
sure to remove all product residues.
Some chemical products used as disinfectants can
harm the organism and the expiratory kits of the
device.
After cleaning and drying, store the device and
its accessories in its carrying bag, in a dry place,
protected from sunlight and dust, at room
temperature.Please refer to the section in this manual
on storage temperatures for SIMEOX.
The Lithium button battery in the remote control
presents an ingestion risk, to avoid this risk take the
following precautions:
- Do not store new batteries within the reach of
children
- Do not store used batteries in your home, take
them to a collection point
- Do not replace the batteries in the presence of a
child
- Do not let children play with the batteries
- Never put the battery in your mouth to test it or
to keep your hands free
- Never place the battery beside your medicines, to
avoid mistaking it for a tablet
Ingesting a button battery may cause the
following injuries:
- necrosis and perforation of the oesophagus
through mechanical compression
- electrical burns caused by the heat from the
electrical current between the mucosa and the
battery.
In the event that you ingest a button battery
contact a doctor or the emergency services
immediately.
The base of the SIMEOX housing incorporates
openings intended to aerate the device and to
evacuate any condensed moisture.
At home in particular, make sure that no objects,
especially metal objects such as staples, paperclips,
etc. are introduced into the housing through these
openings.
Although the live parts cannot be accessed through
these openings, a small object could remain stuck in
the device and cause a short-circuit.
The wrist strap supplied is intended to ensure that
the remote control is held securely at the wrist
during treatment sessions, preventing it from being
dropped.
It is not pre-installed.
The user is free to install it if he chooses, depending
on the estimated contamination risk.
Keep the power cord away from all hot surfaces: the
heat could degrade the protective sheath and cause
a failure, or a risk of electric shock.
Do not position SIMEOX in such a way that it is
dicult to use the disconnection device (the male
mains plug).

9
2.2 Warnings
Never plug the device into a faulty wall socket, which
could cause a short-circuit that could damage it
Never connect SIMEOX to other appliances
Never expose SIMEOX to the rain: when transporting
SIMEOX use the carrying bag supplied.
Do not use or store the device in a place liable to
cause it to fall, in a damp environment or in extreme
heat.
Please refer to the technical specications for the
temperatures and atmospheric conditions for
storage and use.
Do not use SIMEOX in its carrying bag; the device
would be poorly ventilated and could be damaged.
Do not install SIMEOX on a soft surface such as
a mattress or a carpet: the holes located on the
housing base could be obstructed and cause the
internal components to overheat.
Mettre le SIMEOX hors tension lorsqu’il n’est pas
utilisé.
Cleaning and disinfection of the device, of its
expiratory kits and its accessories, must be carried
out in accordance with our recommendations, please
refer to the corresponding section of the manual for
the relevant recommendations.
Only use the power cord supplied by PHYSIO-ASSIST
for SIMEOX, failing which the device may overheat and
be damaged.
Please keep the device in its carrying bag when
moving it, in order to protect it from liquids and
impacts.
After each use, store the device, its expiratory kits
and its accessories out of the reach of children, pets,
insects, etc.
The following are prohibited as they may damage the
power cord of the device:
- twisting the cord
- placing heavy objects on the cord
- pulling violently on the wall plug cord
- placing the cord in a damp area: risk of short-circuit
that may cause very serious physical and material
damage.
- modifying the cord
Consult the electromagnetic compatibility section
of this document: it contains important information
on how to install and use SIMEOX to avoid any
interference with other electrical devices, including
other medical devices.
Never put SIMEOX back in its bag immediately after
use.
The moisture present in the machine could
condense and cause damage to SIMEOX.
To avoid damaging SIMEOX when turning o the
device, please rst switch it o before unplugging it
from the wall socket.

10
2.3 Recommendations for use
Only use the device on the recommendation of a
healthcare professional.
Only use this device if you have been previously
trained in its use.
Begin the session on a 50% power setting and
adjust signal intensity according to patient
comfort and tolerance, depending on bronchial
stability and sensitivity and the ventilation
volume of the patient.
Do not place your tongue over the mouthpiece
opening, this may prevent the vibrations
from reaching the bronchial tree and reduce
treatment performance.
If the mouthpiece is obstructed, the
performance indicator lights illuminate in red.
In this case, stop using SIMEOX and adjust the
position of the mouthpiece.
Do not use SIMEOX if the lter of the
consumable is not correctly installed.

11
3.1 Components on the back panel
Power switch
This I/O switch turns the SIMEOX device on and o, “I” to turn on
and “O” to turn o.
Mains lter fuse
This location is intended for the mains lter fuses.
Power socket
This connector is for the SIMEOX C17 power cable.
1
1
2
2
3
Destruction of fuses can only be caused by a critical failure of the SIMEOX electronics, for example in
the event of exposure to very high electrostatic discharge, overvoltage, overcurrent, etc.
Tools are required to replace fuses and this must imperatively be carried out by an approved
technician who will rst examine the device to determine the cause of destruction.
Description of Simeox
3
3

12
3.2 Components on the front panel
1
1
2
2
“Go” button
This button is a backup button in the event that the remote control fails.
On both SIMEOX and the remote control, this button starts the SIMEOX vibratory pneumatic signal.
It must be pressed throughout the expiratory phases.
In the event of signicant discomfort or pain, the patient must release the GO button to stop the device.
During a cycle, passing from one expiratory phase to the next requires the “GO” button to be pressed for at least 1.5
seconds.
Connecting the expiratory kits
Location for connecting the lter of the patient expiratory kit.

13
As SIMEOX is not watertight and does not withstand being dropped, it is preferable to use the bag
provided to transport it. In this way your SIMEOX will be best protected from water and impacts.
3.3 Components on the top panel and the remote control
Control pad
The SIMEOX control pad (see below)
Carry handle
This handle is used to transport SIMEOX.
Remote control
The SIMEOX remote control.
Remote control “Go” button
This button starts up the SIMEOX vibratory pneumatic signal.
It must be pressed throughout the expiratory phases.
In the event of signicant discomfort or pain, the patient must release the GO button to stop the device.
During a cycle, passing from one expiratory phase to the next requires the “GO” button to be pressed for at least 1.5 seconds.
1
1
2
3
4
2
3
4

14
3.4 Control pad components
“Standby/On” button
This button activates operation of SIMEOX and its “standby” mode.
When the light is yellow-orange, the device is in standby.
When the light is blinking blue, the device is active but is not
yet usable as it has not detected a valid accessory (usable
SIMEOX expiratory kit): either the expiratory kit used is not
supplied by PHYSIO-ASSIST, or the SIMEOX consumable
allowed use counter is depleted.
In this case: you must replace the accessory to be able to use
SIMEOX.
When the light is steady blue (no blinking), the device is
active and usable.
In order to avoid unintentionally placing SIMEOX on
standby, this operation requires the “Standby/On” button to
be pressed continuously for 3 seconds.
Program adjustment button
This button allows the program to be adjusted to the patient
according to their tolerance:
PROG 1: program 1 is selected for 6 expiratory phases per
cycle
PROG 2: program 2 is selected for 8 expiratory phases per
cycle
PROG 3: program 3 is selected for 10 expiratory phases per
cycle
It is possible to change the program at the end of each cycle, or
during the 45-second pause.
For each program: The last two phases have a frequency that
is lower than that of the preceding phases, in order to increase
transport of the mucus.
This button also triggers a tube dehumidication cycle, see
below.
Power adjustment button
This button adjusts the power of the signal sent to the
patient. It can be adjusted at any time in the session
based on how the patient feels.
It is possible to change the power setting at any time:
during the session, at the end of each program, or
during the 45-second pause.
Remote control battery indicator
This light changes to orange when the remote control
batteries need to be replaced.
Performance indicator
This visual feedback enables the operating quality of the
device to be viewed.
The number of green lights illuminated (between 1 and 5) is
an indicator of the quality of transmission of the pneumatic
signal in the lower airways
The ve green lights should illuminate when the patient
expires.
If the red lights illuminate, the expiration must be stopped
by releasing the remote control button or removing the
mouthpiece.
1
2
3
5
1
2
3
5
4
4

15
3.5 Additional information on the SIMEOX user interface
The SIMEOX interface displays other visual information.
This information is:
On start-up, all lights illuminate for 1.5 seconds allowing the user to check that all lights are working properly.
When pairing the remote control, the “CYCLE” lights illuminate successively clockwise to let the user know that the
pairing has been carried out successfully.
If the remote control pairing is lost, the “CYCLE” lights successively illuminate counterclockwise to allow the user to
know that he will have to pair again the remote control, as communication between the SIMEOX and the remote
control has been interrupted.
In the event of obstruction, the four red lights of the performance indicator light up.
If these lights are illuminated, before resuming the treatment session, the user must stop using SIMEOX
immediately and determine what has caused these lights to come on, for example a blocked lter, a use problem
such as introducing the tongue into the mouthpiece, etc.

16
3.6 The expiratory kits
PHYSIO-ASSIST oers two types of expiratory kits:
Expiratory kits containing single use mouthpieces, whose packaging bears the symbol
Examples of lters:
the number of possible uses is clearly indicated, kits
with single use mouthpieces are dierentiated from
kits with reusable mouthpieces by the colour of the
lter.
Expiratory kits containing multiple use mouthpieces
In order to secure the number of permitted uses, PHYSIO-ASSIST lters are tted with an electronic
component containing the number of permitted uses for the expiratory kit model (RFID TAG). SIMEOX
reads this value before activating: once the number of uses is depleted, SIMEOX will not operate, you
must replace the expiratory kit.
For these kits, the number of mouthpieces supplied is that of the number of possible uses (e.g. 10
mouthpieces for 10 uses): the mouthpiece must be thrown away after each use.
In order to avoid any inter-patient contamination, the expiratory kits are always for single patient use.
According to the medical prescription, the expiratory kit will either contain single use mouthpieces, or
reusable mouthpieces, subject to following the cleaning and disinfection instructions recommended by
PHYSIO-ASSIST. In all cases, comply with the recommendations of the referent healthcare professional.
For these kits, 3 mouthpieces are supplied: it is recommended that the mouthpiece and tube be cleaned
after use for future reuse.

17
4.1 Composition and assembly of the expiratory kit
Expiratory kits are available in the form of resealable bags containing all the necessary components (lter, tube,
mouthpieces, user manual).
The bag contains basic instructions for use and maintenance, the details of these instructions are included in this
user manual.
The kit bag can be resealed hermetically for optimal hygiene.
A label on the bag identies the patient using the kit.
A lter tted with a RFID TAG. This electronic component is
intended to:
Identify PHYSIO-ASSIST expiratory kits: SIMEOX will not
operate with other expiratory kits
Count the number of uses of the accessory: once the
stipulated number of uses is depleted, the accessory is no
longer recognised and cannot be used
A tube
Mouthpieces
Simeox expiratory kits are single patient.
In healthcare facilities and in medical or paramedical practices, each expiratory kit must be allocated to
one patient.
The name of the patient and the date of rst use of the expiratory kit must be indicated on the label
provided for this purpose on the kit bag.
4.1.1 Composition of the expiratory kit:
Use of Simeox
4
1
2
2
3
3
1

18
4.1.2 Assembly of the expiratory kit
To assemble the expiratory kit:
Connect the mouthpiece to the other end: the
mouthpiece and the tube are keyed to enable the
mouthpiece to be installed in an optimal manner and any
risk of leakage or disconnection during the session to be
avoided.
If the mouthpiece packaging is damaged: do not use it and contact PHYSIO-ASSIST or your supplier for
information and to replace the kit.
The lter may already be installed on the tube when opening the bag. This does not mean that the
lter is attached to the tube: it can be removed without diculty for kit maintenance.
Open the bag taking care not to damage it,
as the bag is intended to protect the kit from
dust while not in use.
Pick up the lter.
Connect it to one end of the tube.
1
3
2
4

19
The remote control can be tted on the tube
end sleeve to be used as a “trigger” keeping one
hand free.
Slide the cord into the
hole of the remote
control
Pass the wrist strap through
the cord
Slide the wrist strap into
the cord, the installation is
nished
If you wish to install the wrist strap on the remote control, install as follows:
Note the date the kit was opened and the
patient’s name on the label provided for
this purpose.
Incorrect assembly: the connection
is not optimal
Keyed setup on the tube end
sleeve and the mouthpiece
Correct assembly: the two components
are connected in an optimal manner
5
1 2 3
6
4.1.3 Wrist strap installation
To disassemble the wrist strap, to wash it, carry out the same operations in the reverse order.