1.1 Contents of Simeox .......................................................................................................................................................4
1.2 Pathophysiology of respiratory diseases ...................................................................................................................5
1.3 Use of Simeox .................................................................................................................................................................6
1.4 Warnings and precautions ............................................................................................................................................7
1.6 Overview of Simeox ........................................................................................................................................................9
1.6.1 Control pad elements.................................................................................................................................................. 10
1.6.2 Elements on the front face ........................................................................................................................................ 11
1.6.3 Elements on the back face ......................................................................................................................................... 12
1.6.4 Elements on the top face ........................................................................................................................................... 13
1.7 Symbols used ................................................................................................................................................................ 15
2. Manual
2.1 Assembling and powering Simeox ........................................................................................................................... 16
2.2 Assembling the single patient respiratory kit ........................................................................................................ 17
2.4 Conducting a session .................................................................................................................................................. 19
2
3. Cleaning / Maintenance
3.1 Changing the respiratory kit ...................................................................................................................................... 20
3.2 Remote control ............................................................................................................................................................. 21
3.3 Cleaning the device ...................................................................................................................................................... 22
7. How to contact us? ....................................35
3
1
Introduction
1.1 Contents of Simeox
Simeox contains the following components:
The device
Pneumatic vibrations generator unit Simeox
Remote control
Power cord
Carrying case
User manual
Accessories
Respiratory kit: a lter and a exible connection
tube (for a single patient for 3 or 10 sessions)
and a mouthpiece (disposable).
4
1.2 Pathophysiology of respiratory
diseases
Physio-Assist’s Simeox is intended for patients with
obstructive respiratory diseases congested with
abundant, sticky mucus.
Cystic brosis and COPD are the rst targets of
Simeox.
These patients, for whom bronchial decongestion
is a daily issue, may use Simeox during treatment
for better decongestion quality and autonomy in
its execution.
Physical principle
Simeox is the result of three years of research
at Physio-Assist on the study of bronchial mucus
rheology under the inuence of a vibratory
pneumatic signal. The “Simeox” medical assistance
device for bronchial decongestion is a negative
pressure vibration generator that uses the
thixotropic properties of respiratory mucus.
Laboratory tests and numerical simulations show
a signicant liquefying and draining eect of our
technology on bronchial mucus.
Principle of the medical device
The principle of Simeox is to combine the
liquefaction and drainage action of the bronchial
mucus by vibration of the air during the expiratory
phases.
Simeox allows the patient to perform long and
passive expirations by successive low pressure
signals. Between each low pressure signals,
the patient is reconnected to the atmospheric
pressure, which, combined with passive expiration,
avoids physiological airway collapse, the main
obstacle to decongestion of the peripheral airways.
Simeox transmits to the patient’s bronchial
tree the liquefying and draining signal to thin
and transport secretions in order to facilitate
their disposal. It delivers a succession of low
pressure vibrations at low frequencies to mobilise
secretions and clear the airways. Throughout the
session, the patient spits up the secretions himself.
Use of Simeox is provided in a hospital or
healthcare care.
5
1.3 Use of Simeox
To perform a session Simeox, the patient should always inspire with the device disconnected. During the
expiratory phase, he should begin with a slow expiration into the mouthpiece while operating the remote
control, and then allow the lungs to be emptied by Simeox.
The patient should be relaxed position facing Simeox. The patient is then totally passive during the
expiratory mechanism to prevent airway collapse caused by contraction of the respiratory muscles.
The Simeox liquefying and draining signal will be transmitted throughout the bronchial tree and optimises
drainage of the secretions in the patient’s distal tract.
After a 20 to 30-minute session, the patient is drained. He has coughed naturally throughout the session.
The thinning and drainage of mucus occurs in three phases:
1. Placing of the mouthpiece in the mouth during expiration;
2. Liquefaction of the mucus under the eect of a vibration stimulus during the expiration phases:
thixotropy;
3. Expectoration of liqueed mucus.
Liquefaction and drainage of the congested bronchial tree
6
1.4 Warnings and precautions
WARNING: This section indicates the risk of injury to the user or the operator and the risks of damage to the
device.
Precautions
Only use the device as recommended by a
healthcare professional.
Change the consumables between each patient
for single patient consumables (lters, tube), and
after each use of the mouthpiece
Monitor the device during use and discontinue
use in case of malfunction.
Only use the consumables for one patient /
single use provided by Physio-Assist.
Always disconnect the device during the
inspiratory phase.
Start the session with minimal power and nd
your desired setting by increasing the signal
strength during the session.
Do not use or store the device where it might
fall, in a wet environment or in extreme heat.
Unplug the unit in case of contact with water or
any liquid substance.
Do not use the device in its carrying case.
Do not disassemble the generator; there no
parts that need to be replaced by the user. Only
changing the remote control battery, according
to the manual, is your responsibility. Only
authorised personnel may repair the device.
Only use the power cords supplied by Physio-
Assist for Simeox to avoid overheating and
damaging the device.
Do not block Simeox against a wall so that the
mains switch is accessible.
The use of any accessories not recommended
by Physio-Assist is prohibited.
See the EMC section of this document to comply
with the distances of use and avoid interference
with other medical devices.
The Simeox mouthpiece is intended to come
into contact with the patient’s mouth. In case of
irritation, tingling or allergies, stop using Simeox
and consult a specialist.
Never use Simeox if the cord or plug is
damaged, if the device malfunctions or has
fallen, been damaged or immersed in water.
7
Warnings
Position Simeox so as not to obstruct the hole
in the front and the aeration of the device.
It should not be used near other equipment
or be stacked on them. Contact a healthcare
professional if in doubt.
Never use the appliance if the Simeox lter is
not tted.
Turn the device o when not in use.
Keep the cord away from heated surfaces.
Do not sterilize the device or consumables
regardless of the method.
1.5 Contraindications
Simeox should not cause any patient discomfort or pain. In case of pain, immediately stop the session and
consult a healthcare professional.
Any use is to be made on the recommendation of a medical professional. Simeox is not
recommended for patients:
With a contraindication for bronchial chest
physiotherapy;
With pneumothorax;
With heart disease;
Who have received a lung transplant;
Who are prone to emphysema bubbles;
Who have had recent thoracic surgery;
Who have undergone a recent chest trauma;
Who are pregnant or breastfeeding.
8
1.6 Overview of Simeox
9
1.6.1 Control pad elements
4
1
“On / O” button
This button switches on the device.
When the LED is yellow, the device is “O”
When the LED is blinking blue, the device is “On,” but is inactive because it has not detected new
Simeox consumables
When the LED is constant blue, the device is active
Programme adjustment button
2
This button allows the health professional to preset the programme for the patient according to his tolerance:
PROG 1: Programme 1 is selected for a session of 4x6 respiratory cycles
PROG 2: Programme 2 is selected for a session of 4x8 respiratory cycles
PROG 3: Programme 1 is selected for a session of 4x10 respiratory cycles
Power adjustment button
3
This button adjusts the signal sent to the patient. It can be adjusted at any time during the session based on
what the patient feels.
Remote control indicator
4
This light turns orange when the batteries in the remote control need changing.
Performance indicator
5
This visual feedback allows you to view the performance of the device. It must light up a maximum of green
LEDs. If a red LED lights up, stop the expiration and release the remote control or the mouthpiece.
10
1.6.2 Elements on the front face
1
2
1
“Go” button
This button is a reminder in case of failure of the remote control. This button starts the Simeox vibration.
It must be kept pressed throughout the expiratory phase. If the patient experiences any discomfort, he releases
the button and the device stops.
2
Connection consumables
Location of the air lter connection.
11
1.6.3 Elements on the back face
1
2
3
1
Power switch
The I/O switch turns the Simeox device on and o: “I” to turn on and “O” to turn o.
Mains lter fuse
2
This location is intended for the mains lter fuse.
Power outlet
3
This connector is for the Simeox AC power cable.
12
1.6.4 Elements on the top face
1
2
3
4
1
Control pad
The Simeox control pad (see 1.6.1)
Carry handle
2
This handle allows Simeox to be transported.
Controller remote control
3
Simeox remote control
“Go” button of the remote control
4
This button starts the Simeox vibration. It must be kept pressed throughout the expiratory phase. If the patient
experiences any discomfort, he releases the button and the device stops.
13
1.6.5 Respiratory kit
2
3
1
1
Respiratory lter
Single patient. Maximum 10 uses
The lter is positioned in the Simeox output. It is equipped with an RFID tag that controls that it is used for the
maximum 10 times. The tube must be connected to the lter and the mouthpiece should be connected to the
tube to complete the patient circuit.
Flexible tube
2
Single patient. Maximum 10 uses
Connection tube between the machine lter and the mouthpiece.
3
Mouthpiece
Single use
The mouthpiece is at the end. The patient should pinch it between his lips in the expiratory phase.
14
1.7 Symbols used
CE marking
Conforms to European
Union directives
Alternating current.
The equipment must only be operated
in AC.
Circuit breaker: fuse
Refer to the instruction manual
Refer to the instruction manual
General safety sign
Applied part, type BF (CEI 60601-1)
Note 1 – B = Body.
Note 2 – F = Floating applied part.
Name and address of the manufacturer.
Lower and upper temperature
limits
Humidity limitation
Pressure limitation
Simeox disposal
Do not reuse
Store in a dry place.
Fragile, handle with care.
Top, this way up.
IP20
Device using RF transmitters.
Device protected against solid foreign objects of 12.5 mm diameter and greater.
Device not protected against water drops
falling vertically.
Hand clean.
Use by date
Catalogue reference
Serial number
Batch code
15
2
Manual
Before each use, check the condition of the device and its consumables.
Check the packaging of the consumable is not damaged before opening. In case of damage to
the package, dispose of the consumable directly.
2.1 Assembling and powering Simeox
Simeox is contained in the carrying case. To assemble Simeox:
1. Lift Simeox out of the case and place it on a
stable, level surface;
3. Connect the power cable of the Physio-Assist
to a power outlet;
2. Make sure the air intake areas at the front
and under Simeox are not blocked. The air must
circulate freely around the device;
4. Turn on the device by setting the power switch
to the “On” position (I) on the back of the device.
The LED on the “On / O” button of the control
pad turns yellow.
16
2.2 Assembling the single patient
respiratory kit
With Simeox, Physio-Assist provides breathing kits for 3 to 10 uses on a single patient in a closed
bag. The kit can be resealed and the patient’s name must be written on it.
The kit consists of:
123
1. Respiratory lter equipped with an RFID tag
(adhesive sticker);
2. A corrugated tube;
To assemble the respiratory kit:
1
4
1. Take with respiratory lter equipped with an
RFID tag on the outer part (part connecting to
Simeox);
2. Connect either end of the tube to the other
end of the air lter;
3. A mouthpiece (disposable).
2
3
3. Connect the mouthpiece to the other end of
the tube;
4. The sleeve of the tube is used to connect the
remote control to be used as a trigger and to
keep one hand free.
17
2.3 Device start-up
4
After powering the device and assembling the consumables, to start it up:
1. Press the “On / O” button on the control pad
and verify that the LED above the button ashes
blue;
2. Place the assembled respiratory kit in the
place provided for this purpose (by the free part
of the respiratory lter containing the RFID tag);
3. Verify that the “On / O” button LED of the
control pad stops ashing. This veries that the
supplies are new and provided by Physio-Assist;
4. The session programme and the tolerated
power can now be set by the healthcare
professional;
5. Start the session.
18
2.4 Conducting a session
The Simeox control pad sets two adjustments.
Session programme: “CYCLE”
After the device start-up, the healthcare professional chooses the programme for the patient. The number
of LEDs on the circle around the “clock” symbol indicates the number of expiratory cycles that the patient
should do during each part of the session. A session consists of four parts (4 to 8 minutes) with a pause (45
seconds to 1 minute) between each, for a total duration of 20 to 30 minutes.
During a session, the number of lit LEDs is the number of expiratory cycles to be completed. During the
pause, the LEDs blink.
1. Programme 1: 4 x 6 = 24 expiratory cycles
2. Programme 2: 4 x 8 = 32 expiratory cycles
Signal strength: “POWER”
The arrows around the “POWER” indication decrease (down arrow) and increase (arrow up) the power of
the intra-pulmonary vibration. This setting is kept throughout the session. The patient should maximize the
power, but should not in any case feel discomfort, pain or chest discomfort.
The power can be adjusted over the session because tolerance may increase.
Performance
The indicator to the right of the control keypad with 9 LEDs shows in real time the performance of the
device. The performance must be optimised without the patient feeling any pain or discomfort.
In case of overpressure, red LEDs light up and tell the patient he must instantly stop the expiration, releasing
the remote control and / or the mouthpiece.
Remote control
The remote control is a “dead man” switch that should remain pressed throughout the patient’s expiratory
cycle. If the button is released, the vibration stops.
During the session, the patient inspires normally, and when ready to expire, pinches the mouthpiece
between his lips and starts the passive expiration ensured by Simeox by pressing the “Go” button.
This button is a set on the front of Simeox in case of failure of the remote control.
The remote control must be used within one metre of Simeox for proper operation.
3. Programme 3: 4 x 10 = 40 expiratory cycles
19
3
Cleaning / Maintenance
3.1 Changing the respiratory kit
The Simeox respiratory kit is for a single patient and the mouthpiece may not be reused in any case.
The used respiratory kit must be provided by Physio-Assist and can be implemented by any operator.
ActionOperation to performFrequency
Using a
respiratory kit
After starting and setting up Simeox, connect a
new respiratory kit.
Simeox recognises a new respiratory kit allowing
it to be used.
Mandatory at each
session
20
3.2 Remote control
Battery indicator
When the remote control battery is low, an orange visual indicator lights on the lower right of the control
pad.
Changing the battery
The remote control is equipped with a CR2032 battery. When the battery is low, an orange visual indicator
lights on the lower right of the control pad. The operator can change the battery.
To change the battery:
1. Unscrew the screws
2. Open the remote control by turning the
bottom cover
3. Push out the battery
4. Change the Energizer CR2032 battery.
Slide using your nger the new battery with
the + sign towards you
21
Synchronisation of a new remote control
Any remote control can operate any device. In case of a battery change or replacement of a remote control,
the operator must synchronise it with the device.
To synchronise the remote control:
13
2b
2a
1. Turn o Simeox;
2. When the On / O LED button is yellow, press
and hold the “POWER” button (down arrow) and
press the “On / O” button. The device enters
the synchronisation mode with a new remote
control;
A beep indicates that the remote control is synchronised and ready for use.
3. Press the “Go” button on the remote control
to synchronise it
3.4 Cleaning the device
The outer surface of the device should be cleaned before and after each use:
1. Unplug the device and clean the outside of
the housing with a clean cloth moistened with
water or a mild detergent;
2. After cleaning, check that no water bubbles
remain on the device;
3. Let the device dry before reconnecting the
power cord.
22
3.5 Operating incidents
In case of an incident:
Do not attempt to repair the device yourself;
Do not dispose of the medical device in
question;
The device does not start:
The power cord is not properly connected to
the electrical outlet or to the device. Verify the
cord connections;
The aspiration is insucient:
Verify the settings with the healthcare
professional.
The oscillations do not occur:
Report the incident immediately.
Turn the power o (button on the back);
Report the incident immediately to the
healthcare professional or directly to the
distributor (see contact information in section 6).
A fuse may be damaged.
Report the incident.
Verify that the elements interlock with each
other as there may be a leakage between the
connections of the removable elements.
Liquids or solids have been introduced into the housing:
Report the incident immediately.
23
4
EMC information
Warning! Portable and mobile radio frequency communication devices, such as cordless
telephones may aect the operation of Simeox.
4.1 Cables and accessories
Simeox comes with a 5-metre Decelect power cable, reference SPE191457.
Warning! Use of cable and accessories other than those listed above may aect the operation of Simeox. This may
result in increased emissions and / or decreased immunity of Simeox.
24
4.2 Guidelines and manufacturer’s declaration - electromagnetic emissions
Simeox is intended for use in the electromagnetic environment specied below. The customer or user of
Simeox must ensure that it is used in such an environment.
functions. Therefore, its RF emissions are very low
and are not likely to cause interference in nearby
electronic equipment.
Harmonic emissions
IEC 61000-3-2
Voltage uctuations
and icker emissions
IEC 61000-3-3
Warning! The use of Simeox when stacked on or near other equipment may aect its operation.
Not
applicable
Not
applicable
Simeox suitable for use in all premises other than
domestic premises and those directly connected
to the low voltage public grid of buildings for
domestic use.
25
4.3 Guidelines and manufacturer’s
declaration - electromagnetic immunity
Simeox is intended for use in the electromagnetic environment specied below.
Immunity testIEC 60601 standard Level of compliance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Fast transient
burst IEC 610004-4
NOTE: UT is the ac mains voltage prior to application of the test level: 230 V
± 6 kV on contact
± 8kV in air
± 2 kV electric power
lines
± 1 kV for input /
output lines
± 6 kV on contact
± 8kV in air
± 2 kV for electric
power lines
± 1 kV for input /
output lines
Electromagnetic environment
- guidelines
The oors should be wooden,
concrete or ceramic tile. If oors
are covered with synthetic
material, the relative humidity
needs to be at least 30%.
The quality of the power supply
network must be that of a
typical commercial or hospital
environment.
26
Immunity testIEC 60601 standardLevel of compliance
Electromagnetic environment
- guidelines
Voltage
dip, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Magnetic
eld at
the mains
frequency
(50/60 Hz)
IEC 610004-8
<5% UT (> 95%
dip in UT) for 0.5
cycle 40% UT
(60% dip in UT)
for 5 cycles 70%
UT (30% dip in
UT) for 25 cycles
<5% UT (> 95%
dip in UT) for 0.5
cycle 40% UT
(60% dip in UT)
for 5 cycles 70%
UT (30% dip in
UT) for 25 cycles
The quality of the power
supply network must be
that of a typical commercial
or hospital environment.
The quality of the power
supply network must be
that of a typical commercial
or hospital environment.
<5% UT (> 95%
dip in UT) for 5 s
<5% UT (> 95 %
dip in UT) for 5 s
If the Simeox user requires
continued operation
during breaks of the
power supply network,
it is recommended to
power Simeox by an
uninterrupted power
supply or battery.
3 A/m3 A/mThe magnetic elds in the
frequency of the electrical
network should have the
levels of a regular location
in a typical commercial or
hospital environment.
27
Immunity testIEC 60601 standardLevel of compliance
Electromagnetic environment
- guidelines
Tube RF
disturbances IEC
61000-4-6
Magnetic eld
at the mains
frequency (50/60
Hz) IEC 61000-4-8
3 Vrms 150 kHz to 80
MHz
3 V / m 80 MHz to 2.5
GHz
3 Vrms 150 kHz to
80 MHz
3 V / m 80 MHz to
2.5 GHz
Portable and mobile RF
communications should not
be used nearer any part of
Simeox, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
transmitter frequency.
Recommended separation
distance “d”:
d = (3.5 / 3) √P 150 kHz to 80
MHz
d = (3.5 / 3) √P 80 MHz to 800
MHz
d = (7 / 3) √P 800MHz to 2.5GHz
Where P is the maximum
output power of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
The eld strengths from xed RF
transmitters, as determined by
an electromagnetic site, should
be less than the compliance
level in each b frequency range
Interference may occur near
equipment marked with the
following symbol:
28
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people
a: Field strengths from xed transmitters, such as base stations for (cellular / cordless) radiotelephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
onsite electromagnetic investigation should be conducted. If the eld strength measured at the location
where the [EQUIPMENT or ME SYSTEM] is used exceeds the RF compliance level above, Simeox should be
observed to verify that operation is normal. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or repositioning of Simeox.
b: In the frequency range of 150 kHz to 80 MHz, eld strengths must be smaller than 3V / m.
29
Simeox is intended for use in the electromagnetic environment specied below.
Radiated RF are controlled. The Simeox customer or user can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications devices (transmitters)
and Simeox, as recommended below, according to the maximum power emission of the communications
device.
Maximum as-
signed output
power of the W
Separation distance according to frequency of the m transmitter
For transmitters whose assigned maximum transmission power is not given above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum transmission power of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the highest range of frequencies is applied.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
30
4.4 Communications
Simeox uses cordless communications in the following bands:
BLE Bluetooth: [2.400 GHz - 2.4835 GHz] with
a bandwidth of 2 MHz per communication
channel;
Warning! Because of its Bluetooth and RFID operations, Simeox can be subject to interference from other
products, even if they comply with CISPR emission requirements.
To communicate via Bluetooth, Simeox uses GFSK modulation for an eective radiated power of 3 mW on
the band [2.400 GHz-2.4835 GHz].
To communicate via RFID, Simeox uses ASK modulation for a radiated power of 0.2512 µA / m in the frequency of 13.56MHz
RFID : 13.56 MHz.
4.5 Medical devices designed to operate
with Simeox and its accessories
The Simeox medical device;
The Simeox remote control;
The Simeox accessories: Filter and tube, mouthpiece;
The Decelect power cable, reference SPE191457.
Warning! Using the Simeox cables and accessories with medical devices other than those listed
above may aect the operation of the medical device in question.
This may result in increased emissions and / or decreased immunity of this medical device.
31
5
Technical specications
Environment
OperationStorage
Temperature10 °C to 30 °CAmbient temperature
Relative humidity
Atmospheric pressure800 hPa to 1,020 hPa< 2000m
5 to 80%
(non-condensing)
Physical specications
Simeox dimensions: l 278 mm x w 215.5 mm x h 174.1 mm
Weight: 4.6 kg
Electrical specications
Voltage source: 90-264 VAC 50/60Hz
Power: 100 VA
Dry place
32
Displayed settings
The settings displayed on the PERFORMANCE indicator are purely indicative.
Disposal
This product conforms to CE marking standards of the DEEE Directive (2012/19 / EU). The presence of this
label indicates that this electrical / electronic device may not be disposed of with household waste.
Destruction of Simeox: Return the device, the power cable and the remote control to the distributor who will
forward it to the manufacturer who has sole authority to disassemble and recycle the Simeox components
(according to the DEEE in force).
33
6
Warranty / Customer services
Physio-Assist guarantees Simeox for one year for all
defects of material and workmanship from the date
of sale of the device.
In case of malfunction, Physio-Assist repairs or
replaces the equipment, or the faulty component.
This warranty does not cover damage caused by
accident, misuse, abuse, modication or other
defects not related to material or workmanship.
Physio-Assist disclaims all liability for economic loss,
loss of prots, overheads or consequential damages
that may be reported as resulting from sale or use
of this product. Some countries do not allow the
exclusion or limitation of incidental or consequential
damages. The above limitation or exclusion may
not apply in your case. Accessories and spare parts,
including but not limited to the circuits, tubes, lters,
mouthpieces and fuses, are not covered by this
warranty.
This warranty supersedes all other express
warranties. In addition, any implied warranties,
including any warranties of merchantability or
tness for a particular purpose, are limited to one
year. Some countries do not authorise the period of
limitation of implied warranties; therefore, the above
limitation may not apply in your case. This warranty
gives you specic legal rights, and you may have
other rights, which vary by country.
To exercise your warranty rights, contact your
Physio-Assist dealer or contact Physio-Assist. Our
contact details are in the “how to contact us?”
section. These details may change. You can nd our