PhysioAssist SIMEOX Operation and maintenance manual

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SIMEOX
User notice

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1. Introduction
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
1.5 Contraindications ............................................................................................................................................................8
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
1.6.5 Respiratory kit ............................................................................................................................................................... 14
1.7 Symbols used ................................................................................................................................................................ 15
2. Manual
2.1 Assembling and powering Simeox........................................................................................................................... 16
2.2 Assembling the single patient respiratory kit........................................................................................................ 17
2.3 Device start-up.............................................................................................................................................................. 18
2.4 Conducting a session .................................................................................................................................................. 19
Table of contents

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3. Cleaning / Maintenance
3.1 Changing the respiratory kit ...................................................................................................................................... 20
3.2 Remote control ............................................................................................................................................................. 21
3.3 Cleaning the device...................................................................................................................................................... 22
3.4 Operating incidents ..................................................................................................................................................... 23
4. EMC Information
4.1 Cables and accessories............................................................................................................................................... 24
4.2 Guidelines and manufacturer’s declaration - electromagnetic emissions..................................................... 25
4.3 Guidelines and manufacturer’s declaration - electromagnetic immunity...................................................... 26
4.4 Communications........................................................................................................................................................... 31
4.5 Medical devices designed to operate with Simeox and its accessories ......................................................... 31
5. Technical specications ...........................32
6. Warranty / Customer services ................34
7. How to contact us? ....................................35

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Introduction
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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).

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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 inuence 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 signicant liquefying and draining eect 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.
1.2 Pathophysiology of respiratory
diseases

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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.
Liquefaction and drainage of the congested bronchial tree
1.3 Use of Simeox
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 eect of a vibration stimulus during the expiration phases:
thixotropy;
3. Expectoration of liqueed mucus.

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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.
Never use Simeox if the cord or plug is
damaged, if the device malfunctions or has
fallen, been damaged or immersed in water.
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.
1.4 Warnings and precautions
Precautions
WARNING: This section indicates the risk of injury to the user or the operator and the risks of damage to the
device.

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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.
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.
Warnings
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:

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1.6 Overview of Simeox

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1.6.1 Control pad elements
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2
3
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“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
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
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
This light turns orange when the batteries in the remote control need changing.
Performance indicator
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.
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2
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5

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1.6.2 Elements on the front face
“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.
Connection consumables
Location of the air lter connection.
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2
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2

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1.6.3 Elements on the back face
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
This location is intended for the mains lter fuse.
Power outlet
This connector is for the Simeox AC power cable.
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2
3
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3

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1.6.4 Elements on the top face
Control pad
The Simeox control pad (see 1.6.1)
Carry handle
This handle allows Simeox to be transported.
Controller remote control
Simeox remote control
“Go”button 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.
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1.6.5 Respiratory kit
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
Single patient. Maximum 10 uses
Connection tube between the machine lter and the mouthpiece.
Mouthpiece
Single use
The mouthpiece is at the end. The patient should pinch it between his lips in the expiratory phase.
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1

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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.
Device using RF transmitters.
Device protected against solid foreign ob-
jects of 12.5 mm diameter and greater.
Device not protected against water drops
falling vertically.
Hand clean.
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.
Use by date
Catalogue reference
Serial number
Batch code
IP20

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Manual
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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.
Simeox is contained in the carrying case. To assemble Simeox:
2.1 Assembling and powering Simeox
1. Lift Simeox out of the case and place it on a
stable, level surface;
2. Make sure the air intake areas at the front
and under Simeox are not blocked. The air must
circulate freely around the device;
3. Connect the power cable of the Physio-Assist
to a power outlet;
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.

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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:
To assemble the respiratory kit:
2.2 Assembling the single patient
respiratory kit
1. Respiratory lter equipped with an RFID tag
(adhesive sticker);
2. A corrugated tube;
3. A mouthpiece (disposable).
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. 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.
1 2 3
1
2
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4

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After powering the device and assembling the consumables, to start it up:
2.3 Device start-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 veries 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.
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2
3
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5

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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.
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.
2.4 Conducting a session
1. Programme 1: 4 x 6 = 24 expiratory cycles
2. Programme 2: 4 x 8 = 32 expiratory cycles
3. Programme 3: 4 x 10 = 40 expiratory cycles

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Cleaning / Maintenance
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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.
Action Operation to perform Frequency
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