YEL

SLEEP BREATHING DEVICE

USER MANUAL
CPAP, AUTOCPAP, BIPAP, BIPAP AUTO,
BIPAP S/T, BIPAP S/T AVAPS, ASV, Elite
TABLE OF CONTENTS
1 INTRODUCTION 4
1.1 Description of the YEL Sleep Breathing Devices 5
1.2 Intended Use 6
1.3 Indications 6
1.4 Contraindications 8
1.5 About This Manual 8
1.6 ICONS 9
2 SAFETY INFORMATION 9
2.1 General User Precautions 9
2.2 Electrical Safety 10
2.3 Environmental Conditions 10
2.4 Electromagnetic Conditions 11
2.5 Usage of Patient Circuit 11
2.6 Usage of Filters 12
2.7 Cleaning and Maintenance 12
2.8 Adverse Patient Symptoms 12
2.9 Usage of the Humidifier 13
2.10 Usage of Oxygen 13
3 PRODUCT DESCRIPTION 14
3.1 Main Parts (Components) 14
3.2 Accessories used with YEL Sleep Breathing Device: 14
3.3 The YEL Sleep Breathing Device’s Front Panel 15
3.3 The Front View of YEL Sleep Devices 19
3.4 The View of YEL Sleep Breathing Device Back Panel 20
4. SETTINGS OF THE YEL SLEEP BREATHING DEVICE 20
4.1Clinical Setting 20
4.2 Adjustable and Applicable Parameters 21
5 USING THE YEL SLEEP BREATHING DEVICE 22
5.1Checking the YEL Sleep Breathing Device before Use 22
5.2 Switching the YEL Sleep Breathing Device (On and Off) 22
5.3 Using the Menu 22
5.4 Transferring Data between the YEL Sleep Breathing Device and PC 22
5.5 Using the Integrated Humidifier 22
5.6 Using with an External Battery and Lighter Cord 23

2
6 PREPARING THE YEL SLEEP BREATHING DEVICE FOR USE 23
6.1 Installing the YEL Sleep Breathing Device 23
6.2 Placing the YEL Sleep Breathing Device 23
6.3 Connecting the YEL Sleep Breathing Device to the Power Source 23
6.4 Connecting the Patient Circuit 23
Troubleshooting Table & Alarm Codes Table 24
7 MAINTENANCE 24
7.1Cleaning the YEL Sleep Breathing Device 24
7.2 Patient Filter Replacement and Cleaning 26
7.3 Regular Maintenance Control 26
7.4Service and Repair 26
7.5 Storing YEL Sleep Breathing Device 26
7.6 Disposal of YEL Sleep Breathing Apparatus 27
8 SPECIFICATIONS OF YEL SLEEP BREATHING DEVICE 27
8.1 Technical Characteristics 27
8.2 Environmental Characteristics 28
8.3 Physical Properties 28
8.4 Electrical Properties 28
Compliance with Standards; 28
IEC 60601-1Classification; 32
Electromagnetic Compatibility (EMC) 32
Software Information; 33

3
 1 INTRODUCTION

WARNINGS
The YEL Sleep Breathing Device should only be used under the following conditions:
It should be used for the treatment indicated in this manual.
It should be used in accordance with the instructions given by the competent and responsible
clinical staff.
It must be used in accordance with the operating and operating conditions specified in this
manual.
It must be used in conjunction with original and unmodified accessories and accessories
specified or approved by Foras Medical.
Any use other than these may cause personal injury.
YEL Sleep Breathing Device can not be used for any kind of life support treatment.
Read this book carefully. Before starting to use the device, fully understand and learn how to
operate and maintain the YEL Sleep Breathing Device. In this way, correct operation, maximum
performance and maintenance will be ensured.
To verify that the YEL Sleep Breathing Device operates in full performance and in accordance
with the set values, perform a calibration at least once a year and maintain and adjust the
device according to the values.
If power is cut off or the power plug is disconnected while the device is running, the device
emits an audible warning.
Authorized suppliers and persons can enter the settings menu with the password they have.
It is not recommended to be used by children, lactating women, and pregnant women because
there is no clinical study about the use of them.
The device should not be used in units with high ionizing radiation levels such as X-ray
chamber, MR room.
The shelf life of the accessories (hose and mask) is 3 years.
Replacement of accessories should be carried out at least once a year.
Make sure that the power cord and plug are in good condition and the equipment is not
damaged.
Keep the power cord away from hot surfaces.
Avoid electric shock. Do not immerse the device, adapter or adapter cable in water. If liquid is
spilled in or on the device, unplug the appliance and allow the parts to dry.
Always unplug the appliance before cleaning. After cleaning, do not plug in the appliance
before the appliance parts have dried.
Do not use with additional oxygen while smoking or there is fire in the open.
The device should not be used side by side with other equipment or over the other equipment.
Never attempt to open the device. There are no user-serviceable components inside.

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 CAUTION!
Foras Medical reserves the right to make changes to this product without any prior
notification.

CAUTION!

Use only YEL parts and accessories with the device. Parts other than these may
reduce treatment efficiency and / or damage the device.
Place the device where no one is going to hit and the power cord will not be caught.
Make sure that the area around the appliance is dry and clean, and that there are no
sheets, clothing or objects that could clog the air inlet or cover the adapter.
Do not turn the device sideways or reverse. If you have to move the device, make sure
there is no water in the humidifier.
Do not use solutions such as bleach, chlorine or anti-bacterial soap when cleaning the
device. These solutions can reduce the shelf life of the humidifier.
If using the humidifier, always place the device on a flat surface lower than your head
to prevent the mask and air tube from filling with water.
Use the device in accordance with the environmental requirements in this manual.
When you encounter a problem while using the YEL Sleep Breathing Device, refer to
the troubleshooting table.
The contact information of Foras Medical is available on the last page of this manual
for help or notification.
Do not use the YEL Sleep Breathing Device in an extremely dusty environment.
Carry out the YEL Sleep Breathing Device in its bag.
The temperature of the tray under the YEL water tank can be 65 C. After stopping the
device, wait for 10 minutes to cool down and proceed.
Only water should be filled in the YEL water tank. Do not add any drugs or chemicals.
If it is necessary to use the device, a spare device should be available.
Does not contain animal tissue, human blood or human residues and phtalath.

1.1 Description of the YEL Sleep Breathing Devices

YEL Sleep Breathing Device (Cpap, AutoCpap, Bipap, Bipap Auto, Bipap S/T, Bipap S/T
AVAPS, ASV and Elite humiditation) is a non-invasive breathing apparatus that provides
continuous positive pressure in patients who can breathe spontaneously.
YEL AUTOCPAP is a non-invasive breathing apparatus that automatically adjusts the
continuous positive pressure application according to patient needs.
YEL BIPAP is a non-invasive breathing apparatus that provides a two-level positive
airway pressure during breathing, giving low pressure during exhalation.

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YEL AUTOBiPAP is a non-invasive breathing apparatus that adjusts the two-level
positive airway pressure according to the patient's needs to avoid intense titration and
pressure change.
The YEL BIPAP S/T is a non-invasive breathing apparatus that can adjust the inspiration
/ expiration time (I: E ratio), back-up rate and rise time when applying two-level positive
airway pressure.
YEL BIPAP s/t AVAPS is a non-invasive breathing apparatus that automatically adjusts
the pressure to provide the patient with the set tidal volume.
YEL ASV is a closed-loop controlled non-invasive breathing apparatus that determines
and applies positive airway support automatically in every breath according to the
patient's minute tidal volume requirement.
YEL Elite; CPAP is a non-invasive inhaler that can adjust the positive airway pressure
according to the selected mode, including AutoCPAP, BiPAP, BiPAP Auto, BiPAP s/t,
BiPAP s/t AVAPS, ASV modes.
The YEL Sleep Breathing Device is not intended for life support or life-sustaining
applications or for transport of critical care patients.
1.2 Intended Use
The Sleep Breathing Device function is intended to deliver continuous positive airway
pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more
than 30 kg).
1.3 Indications
CPAP;
It is used in patients with increased daytime sleepiness, cognitive affect, mood
disorders, insomnia or hypertension, ischemic heart disease, stroke or sleep-related
hypoventilation / hypoxemic syndromes provided that apnea Index (AI) is at least 30 or
apnea-hypopnea index (AHI) is at least 30, or apnea, hypopnea and respiratory effort,
showing the number of awakening breathing index (RDI) is determined to be at least 30
or AHI or RDI is between 5-30.
AutoCPAP;
It is used in patients with increased daytime sleepiness, cognitive affect, mood
disorders, insomnia or hypertension, ischemic heart disease, stroke or sleep-related
hypoventilation / hypoxemic syndromes in addition, who cannot tolerate high pressure or
cannot tolerate treatment with constant pressure devices (CPAP) provided that apnea
Index (AI) is at least 30 or apnea-hypopnea index (AHI) is at least 30, or apnea,
hypopnea and respiratory effort, showing the number of awakening breathing index
(RDI) is determined to be at least 30 or AHI or RDI is between 5-30.
BiPAP;
It is used in patients with increased daytime sleepiness, cognitive affect, mood
disorders, insomnia or hypertension, ischemic heart disease, stroke or sleep-related
hypoventilation / hypoxemic syndromes in addition, who cannot tolerate high nasal
airflow, have significant air leakage in the CPAP mask, or have difficulty breathing
against positive pressure, or sleep-related hypoventilation / hypoxemic syndrome
(restrictive lung disease, chronic obstructive pulmonary disease, obesity-hypoventilation
syndrome, pulmonary Patients with parenchymal or hypoventilation / hypoxemia due to
vascular pathologies etc. that apnea Index (AI) is at least 30 or apnea-hypopnea index
(AHI) is at least 30, or apnea, hypopnea and respiratory effort, showing the number of
awakening breathing index (RDI) is determined to be at least 30 or AHI or RDI is
between 5-30.

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BiPAP Auto;
BiPAP indication is used in patients who cannot tolerate the applied BiPAP pressure or
who cannot decide on the appropriate treatment pressure because the effective BiPAP
pressure is very variable.

BiPAP S/T;
It is used in patients with increased daytime sleepiness, cognitive affect, mood
disorders, insomnia or hypertension, ischemic heart disease, stroke or sleep-related
hypoventilation / hypoxemic syndromes in addition, who cannot tolerate high nasal
airflow, have significant air leakage in the CPAP mask, or have difficulty breathing
against positive pressure, or sleep-related hypoventilation / hypoxemic syndrome
(restrictive lung disease, chronic obstructive pulmonary disease, obesity-hypoventilation
syndrome, pulmonary Patients with parenchymal or hypoventilation / hypoxemia due to
vascular pathologies etc., inspiratory pressure (IPAP ≥ 20 cm H2O) or patients with
apnea at the time of intensive care that apnea Index (AI) is at least 30 or apnea-
hypopnea index (AHI) is at least 30, or apnea, hypopnea and respiratory effort, showing
the number of awakening breathing index (RDI) is determined to be at least 30 or AHI or
RDI is between 5-30.

AVAPS;
This treatment is used to patients who polysomnography-guided BPAP s/t titration is not
provided with adequate tidal volume, or in patients with respiratory failure cannot be
eliminated and patients who with sleep-related hypoventilation-hypoxemia (restrictive
lung disease) due to neuromuscular and / or chest wall disorders. (ALS, obesity-
hypoventilation syndrome, kyphoscoliosis, etc.)

ASV;
ASV therapy is used for patients that with central apnea or Cheyne-Stokes respiration
during polysomnography examination, CPAP, BPAP s/t treatments, sleep-related
breathing disorders cannot be prevented or patient compliance and continuous use
cannot be achieved during the titration night or that without CPAP, BPAP s/t treatments
during pressure titration with central apnea or Cheyne-Stokes breathing in the
foreground or in patients with congestive heart failure with an ejection fraction of less
than 40% during the first night polysomnography examination.

Elite;
The device is a multi functional therapy that includes Cpap, AutoCpap, Bipap, Bipap
Auto, Bipap S/T, Bipap S/T Avaps and ASV treatments. It can be used in all respiretory
support patients from Cpap patient to ASV patients thanks to the mode options.Can not
be used as a life support unit. It is designed to be used as a breathing support device to
remove sleep apnea. There is no connect with the patient. The device is supplied air to
the patient through the mask and hose.

YEL Water Tank;

It is a plastic container that can be integrated top of the device in order to enable the
humidifier of the YEL Sleep Breathing Device to be active.

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1.4 Contraindications
Therapy with the YEL Sleep Breathing Device should not be prescribed when the
following specific diseases or conditions are present:
 Bullous lung disease
 Pathologically low blood pressure
 Severe cardiac arrhythmias
 Coronary artery disease
 Unstable angina pectoris
 Decompensated cardiac failure or hypotension, particularly if associated with
intravascular volume depletion
 Recent thoracic surgery
 Pneumothorax
 Pneumomediastinum (lack of air an gas in the mediastinal connective tissue)
 Massive epistaxis or previous history of massive epistaxis (risk of recurrence)
 Pneumoencephalus,recent trauma or surgery that may have produced cranio -
nasopharyngeal fistula
 Cerebral spinal fluid (CSF) leaks
 Acute or unstable respiratory failure or insufficiency
 Caution should be used when prescribing BiPAP S/T therapy for susceptible
patients, such as patients with abnormalities of the cribriform plate, or prior
history of head trauma.
 The use of Sleep Breathing Device therapy may be temporarily contraindicated if
the patient exhibits signs of a sinus or middle ear infection.

1.5 About This Manual

Always read this manual before setting up and using the YEL Sleep Breathing Device or
performing maintenance on the YEL Sleep Breathing Device, to ensure correct usage,
maximum performance and serviceability.
Foras Medical reserves the right to make changes to the contents of this manual without
any prior notification.
This manual is primarily intended for care providers, clinical personnel, physicians and
others who require a working knowledge of the YEL Sleep Breathing Device system.
The manual comprises detailed information on the settings and functions of the YEL
Sleep Breathing Device to be handled by trained health care personnel only.

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1.6 ICONS
In this manual, icons are used to highlight specific information. The meaning of each
icon is explained in the table below.
Read This manual thoroughly
before connecting the Sleep Serial Number
Breathing Device to the patient.
Direct Current
Caution

Read “Disposal” for information

Body Floating (IEC 60601-1 Type about recycling and disposal.
BF, isolated Applied Part)

Storage Temperature
Manufacturer

Protected against solid objects

Keep away from sunlight greater than 12.5 mm and against
dripping water. IP21

Class II Equipment; double

Keep Dry insulation

CE Marking applies in
accordance with the directive SD Card
MDD 93/42/EEC

2 SAFETY INFORMATION
2.1 General User Precautions
• YEL Sleep Breathing Devices should not be used for any life support treatment.
• YEL Sleep Breathing Devices should only be used by patients with spontaneous
breathing.
• If the patient is hospitalized or undergoes any other type of medical treatment, he /
she should always inform the relevant health personnel that receiving medical
ventilation treatment.
• YEL Sleep Breathing Devices must be used under the following conditions:
- It should be used for the treatment specified in this manual and in accordance
with the instructions given by the competent and responsible clinical personnel.
- It must be used in accordance with the conditions of use and operation specified
in this book.
- It must be used with the original and only accessories specified or approved by
Foras Medical.
• In the event of suspicious damage to the device, in case of unpredictable or
sudden pressure, performance or sound changes during operation of the device,
YEL Sleep Breathing Device should not be used and contacted with the Foras
Medical Representative if the air supplied from the YEL Sleep Breathing Device
is abnormally hot or emits an odor.
• The treatment settings of YEL Sleep Breathing Devices must be performed by
authorized clinical personnel in accordance with medical recommendations.
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 • The YEL Sleep Breathing Devices Control procedures should always be applied
before use.
• Inadequate use of the device or accessories may result in loss of treatment or
poor performance.
• Patient and clinical staff should read this book thoroughly and understand its use
thoroughly and learn it before installing and using the YEL Sleep Breathing
Devices.
• YEL Sleep Breathing Devices should be handled with care and used carefully.
• Sleep Breathing Devices should not be used or operated in the bag.
• Use of masks that do not allow spontoneous breathing may cause suffocation

2.2 Electrical Safety

• The YEL Sleep Breathing Device should not be operated and should not be used
if a damaged power cord, power supply or protective coating is present.
• The YEL Sleep Breathing Device may not work properly if any part has been
dropped, damaged, or submerged.
• To avoid electric shock, the power supply cable of the YEL Sleep Breathing
Device should be unplugged before cleaning. YEL Sleep Breathing Device should
not submerged in any liquid.
• The YEL Sleep Breathing Device power supply cable should not be plugged in
while the humidifier is being held or hand held.
• If an external battery is used, this connection should always be interrupted when
the YEL Sleep Breathing Device is switched off. Otherwise, there is a risk of
battery discharge.
• Since the device has no internal battery, when the power is cut off, the device
alarms and switches off. Precaution shall be taken for the patient safety against
power failure.

2.3 Environmental Conditions

• The YEL Sleep Breathing Device should not be used in any toxic environment.
• The YEL Sleep Breathing Device must not be used in the presence of explosive
gases or other flammable anesthetic agents. Do not approach with fire against
risk of flammability.
• Storage conditions are between -20 ° C and 50 ° C.
• The YEL Sleep Breathing Device should not be used under the following
conditions, because the performance of its will be degraded.
• Ambient temperature below + 50C (41OF) and above 400C (1040F)
• Where the relative humidity is below 15% RH and above 95% RH
• Atmospheric pressure below 700 mbar and above 1060 mbar.
• Conditions exposed to a warm place such as direct sunlight
• Do not use outside the humidity limits mentioned in this book.
• Do not use the YEL Sleep Breathing Device in extremely dusty places.
• The sound level of the device was measured as 28 dB (A) at 10 cm H2O
pressure.
• The pressure deviation of device is ± (3,0 hPa + %5 of setting pressure)

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2.4 Electromagnetic Conditions
The device complies with the EMC requirements of standards. Necessary measures
should be taken in order to assure that field levels exceeding 10 V/m are avoided, since
this may impair the safety and performance of the YEL Sleep Breathing Device.
Measures should include but not be limited to:
- In order to minimize the accumulation of electrostatic current, normal precautions
should be taken regarding relative humidity and permeability characteristics of the
garments.
- Radio transmitters should be avoided for use more than 1 m from the YEL Sleep
Breathing Device. Radio transmitters, such as mobile phones or wireless phones,
microwave ovens and high-frequency surgical instruments, should not be brought
closer to the YEL Sleep Breathing Device than 1m.
• YEL BiPAP S/T, any accessories and all replaced parts must be disposed of in
accordance with the local environmental regulations
• The performance of the YEL BiPAP S/T and treatment of the patient may
deteriorate if the operation conditions in “Technical Specifications” are not fulfilled.
Do not use the YEL BiPAP S/T immediately after storage or transport outside the
recommended operating conditions.
Note: Electromagnetic compaitibility tables are viewed in the Electromagnetic
Compatibility section of the book.

2.5 Usage of Patient Circuit

• The YEL Sleep Breathing Device should only be used with the mask and patient
hose recommended by Foras Medical and authorized-qualified medical
personnel.
• Do not breathe with the patient circuit connected to the device unless the YEL
Sleep Breathing Device is switched on and not working properly.
• Patient hoses or tubes made of static or electrically conductive materials should
not be used.
• The YEL Sleep Breathing Device should be used with a new mask and hose
when used by a new patient.
• For proper and effective operation of the YEL Sleep Breathing Device, the parts
and filters connected to the patient should be replaced regularly. All replaced
parts must be disposed of and disposed of according to local environmental rules
and regulations on disposal of used parts.
• If the patient is wearing a full mask (covering and covering the mouth and nose),
the mask must have a safety discharge valve.
• Ensure that the ventilation hole in the mask or the valve connections of the
ventilation valve is not blocked and blocked. These devices are used to ventilate
the mask to prevent the inhaled air from being inhaled again. Repeated inhalation
of the exhaled air for more than a few minutes may cause drowning in some
cases.
• At low device pressures, the air flowing through the ventilation holes in the mask
or the adjacent ventilation valve may not be sufficient to clean the entire exhaled
gas from the mask. Some reinhalations may occur.

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2.6 Usage of Filters
• The YEL Sleep Breathing Device should always be used with an air entry filter
installed. Only the filters specified in this book should be used.
• For proper and effective operation of the YEL Sleep Breathing Device, the filters
should be replaced or cleaned regularly, especially when the patient changes.
Failure to replace the filter or clean a dirty filter may cause the YEL Sleep
Breathing Device to operate at a higher temperature than intended.
• When using the YEL Sleep Breathing Device, make sure that the air entry and
filter are not blocked.

2.7 Cleaning and Maintenance

• The YEL Sleep Breathing Device should be cleaned and maintained in
accordance with the provisions of this book.
• The YEL Sleep Breathing Device should not be autoclaved and sterilized.
• Wipe with residual materials such as alcohol against residual risk in case of
prolonged use of the device.
• Any applicable updates regarding the maintenance, service and control of the
YEL Sleep Breathing Device must be carried out according to the Foras Medical
service instructions.
• The YEL Sleep Breathing Device should only be repaired and modified by
qualified service technicians authorized by Foras Medical, in accordance with
Foras Medical service books, technical bulletins and any special service
instructions.
• Under no circumstances should persons not authorized to do so should service or
repair the YEL Sleep Breathing Device. The manufacturer will not accept any
responsibility for the performance and safety of the YEL Sleep Breathing Device if
the device is serviced or repaired. Also in this case the warranty will not apply.

2.8 Adverse Patient Symptoms

• If the patient experiences any of the following symptoms while using the YEL
Sleep Breathing Device, a physician or responsible clinician shall be contacted
immediately:
• Bloated feeling from excessive swallowing of air while awake
• Air continually leaking from the mouth while sleeping
• Dryness of air passages or nose
• Ear pain, runny nose or sinus discomfort
• Day time sleepiness
• Disorientation (Loss of ability to adapt to the environment), memory lapse, decline
in the ability to remember
• Mood change or irritability
• Skin sensitivity
• Morning headache

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2.9 Usage of the Humidifier
• Humidifier and YEL Sleep Breathing Devices are designed for non-invasive use.
• When using a humidifier, the YEL Sleep Breathing Device should be placed
below the patient to prevent injury and injury from accidental spills.
• If the room humidifier is used, it should be placed at least 2 meters away from the
YEL Sleep Breathing Device.
• The humidity in the patient circuit must be checked periodically. It should be
established if there is moisture. The circuit should be removed from the YEL
Sleep Breathing Device to prevent water from escaping into the YEL Sleep
Breathing Device before starting the circuit. The frequency to which moisture
controls should be performed depends on the patient's position and the condition
of the device used.
• If the density in the patient circuit is too high, the water humidifier in the circuit
should be mounted to the heated humidifier.
• The water trap prevents any condensed water in the patient circuit from escaping
into the patient's airways and thereby causing personal injury.
• The water in the humidifier must be drained during transport.
• Clean water (heated and boiled) should be placed in the water tank.

2.10 Usage of Oxygen

• The presence of oxygen accelerates the ignition and combustion of flammable
and combustible substances.
• If oxygen use is desired and prescribed, the oxygen supply pipe should be
connected to the appropriate oxygen inlet of the nasal mask or respiratory system
connection.
• In the complementary oxygen flow at constant flow rate, the concentration of
inhaled oxygen varies depending on the given pressure, the patient's respiration
structure, the mask chosen and the rate of leakage.
• When using the YEL Sleep Breathing Device with oxygen, the oxygen flow should
be switched off when the YEL Sleep Breathing Device is not operating. If the
oxygen flow continues while the YEL Sleep Breathing Device is not functioning,
the oxygen supplied to the patient tube and circuit may accumulate inside the
machine. The oxygen accumulated in the machine creates a fire danger.
• The room should be adequately ventilated after and after oxygen use.
• Smoking should not be used in the room where oxygen is used.
• Light bulbs and other ignition, ignition and contact sources should be kept at least
2 meters away from the oxygen tube or any other parts of the patient circuit.
• Aerosol or solvent should not be used near the oxygen supply even if the oxygen
cylinder or source is closed.

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3 PRODUCT DESCRIPTION
3.1 Main Parts (Components)
The YEL Sleep Breathing Device system contains the following components.
Parts Function
1 Carrying Bag To protect YEL Sleep Breathing Device
2 User Manual Product and usage information
3 Mask Nasal and Oro-Nasal
4 Patient Tube Device with mask connection material
5 Power Supply Operation of YEL BiPAP S/T
6 AC Power Cord Power Cable
7 Filter (grey: washable) Inlet Air Filtration
YEL Sleep Breathing Device
8 Device
Main Unit
Note: If there are missing parts, contact your supplier

Product Life: Product life is 10 years. This time is valid for use as specified in the
operating instructions. For example; blower motor is broken when used without filter
cleaning or water enters the device, if the humidifier is not used as described.Such
conditions affect the life of the devices.

3.2 Accessories used with YEL Sleep Breathing Device:

Mask: It is used to give positive air pressure from the device to the patient. It differs
according to use as mouth-nose, nose and full face masks. Their size varies according
to the patient face type. The use of masks is according to the doctor's recommendation.
Hose: It is used to deliver positive air pressure from the device to the patient. Provides
connection between device and mask. 22mm in adult patients and 15mm in diameter in
pediatric patients should be used. Recommended hose length is 180cm.
Adapter: The devices operate with an external 24 Volt DC 3 Ampere adapter. The
connector output of the adapters is only compatible with the YEL Sleep Breathing
Device. The cable length of the adapter is 130 cm and the cable length of the plug is 140
cm.

3.3 The YEL Sleep Breathing Device’s Front Panel

YEL Sleep Breathing Device is controlled by
touch screen.
You can see the time, date, active language
and active mode in the top bar of the opening
screen. To change the time, date, and active
language option, go to the Setup Screen and
the Clinical Setup Screen to change the active
mode.Use the on-off button on the left to start
therapy. From the menu on the right, you can
access the information page, setup page, and
clinical setup pages.

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 Information Page

At the beginning of this page is the name of

the YEL Sleep Breathing Device and the
second line contains the serial number of the
device. Below is the total running time of the
device and the therapy times of the last
appliance. Using the QR code on the right, you
can access our website at the bottom of the
screen.The clock key in the lower right corner
of the screen is used to reset the user therapy
time. To return to the opening screen, use the
reverse button on the lower left.

Setting Page

Setting Page
The smart breath value on the setting page is unique to the CPAP mode and allows you
to breathe easier. The active YEL Sleep Breathing Device mode in the top right corner is
not on the screen unless CPAP is present.
You can set ramp pressure, ramp time from this screen. The ramp feature is not
activated when ramp time is 0.
You can adjust the humidity level of the humidifier in the 0-10 range. When set to 0, the
humidifier is not activated.
The brightness of the screen and the darkening time of the screen are set on this page.
Brightness adjustment is 10 levels. Screen darkening time is expressed in minutes.
When set to 0, the screen will not darken.
By tapping the time at the top of this page, you can switch to the date display by tapping
the date on the clock display. When you touch the flag, the language tab will open. You
can change the language of the device by selecting the desired language from the
options.
15
 Language Tab
Language selection can be choose from
this menu as shown in the left figure.

Settings Bar
The adjustment bar appears when you
touch the object you want to change and is
uncomplicated to use. Adjust the values
by sliding the bar or using the “<” and “>”
at the top right and top left. Then click the
OK icon to confirm the change.

Time Page
Tap the clock on the settings page to
access this page. In this page, you can set
the time display, time and set the alarm.
When setting the clock, make sure that the
value you enter corresponds to the 24-hour
format. To return to the setting screen, use
the back button at the bottom left.

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 Date Page
Tap the date on the settings page to
access this page. On this page, you can
set the date and date of the display.
When you set the date, consider the
format you are using. Use the last 2 digits
of the year (example: 2018 18). To
return to the setting screen, use the back
button at the bottom left.

Clinical Setting Page

The YEL Sleep Breathing Device mode
parameters that are active when you
enter the Clinical Setting Page are
displayed. On this page, you can select
the operating mode of the device from
the top right corner. You can view and
change the values that can be adjusted
according to this operating mode.

The Parmeters of Clinical Settings

Parameters found in the CPAP clinical
setting screen;
Pressure: Determines the target pressure
value.
Parameters found in the A-CPAP clinical
setting screen;
Pressure Min: Determines the lower limit
of the PAP value to be set automatically.
Pressure Max: Determines the upper limit
of the PAP value to be set automatically.

17
Parameters found in the BPAP clinical setting screen;
Epap: Determines the pressure given during exhalation.
Ipap:Determines the pressure given during inhalation.
Etrig: Determines the exhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Itrig: Determines the inhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.

Parameters found in the A-BPAP clinical setting screen;

Epap Min: Determines the lower limit of the Epap value to be set automatically.
Epap Max: Determines the upper limit of the Epap value to be set automatically.
Ipap:Determines the pressure given during inhalation.
Etrig: Determines the exhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Itrig: Determines the inhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.

Parameters found in the BPAP-ST clinical setting screen;

Epap: Determines the pressure given during exhalation.
Ipap:Determines the pressure given during inhalation.
Etrig: Determines the exhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Itrig: Determines the inhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Bpm: Sets the minimum number of breaths per minute.
Inhalation Time: Determines inhalation time in seconds.

Parameters found in the AVAPS clinical setting screen;

Epap: Determines the pressure given during exhalation.
Ipap min:Inhalation determines the minimum value of pressure to be given according to
target tidal.
Ipap max: Inhalation determines the maximum value of pressure to be given according
to target tidal.
Etrig: Determines the exhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Itrig: Determines the inhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Bpm: Sets the minimum number of breaths per minute.
Inhalation Time: Determines inhalation time in seconds.
Tidal Volume: Specifies the target tidal volume.

Parameters found in the ASV clinical setting screen;

Epap: Determines the pressure given during exhalation.
PS Min:Determines the minimum value of additional pressure on epap in inhalation.
PS Max:Determines the maximum value of additional pressure on epap in inhalation.
Etrig: Determines the exhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.

18
Itrig: Determines the inhalation trigger level. It consists of 5 stages between 1-5.
Increased patient effort for the trigger increases as the stage rises.
Bpm: Sets the minimum number of breaths per minute.
Inhalation Time: Delivers inhalation time in seconds.

Operation Screen
Operation shows the instantaneous value
of the bar pressure at the right edge of the
screen. Below the screen there are tidal,
breathing and leakage values updated in
each breath. You can move to the chart
page in the upper left corner. To return to
the opening screen, use the back button
at the bottom left.

Chart Page
You can access this page from the work
screen and touch any point of the screen
to return to the work screen. On this page
you can view the instantaneous values of
pressure and flow values on the graph..

3.3 The Front View of YEL Sleep Devices

The Usage of YEL Sleep Breathing Devices Front Panel

2 3 4 5

6
9 7
1
8

19
 1.Rotary (Setting Button)
2.Clock
3.Date
4.Language Selection
5.Device Mode
6.Information Screen
7.Setting Screen
8.Clinical Setting Menu
9.On/Off

3.4 The View of YEL Sleep Breathing Device Back Panel

4. SETTINGS OF THE YEL SLEEP BREATHING DEVICE

• The configuration of the YEL Sleep Respiratory therapy settings must be
prescribed by an authorized, licensed doctor and must be set by an authorized
health care professional.
• Always record the values that were set before the patient returned home.

4.1 Clinical Setting

Clinical settings menu can be entered by authorized suppliers and persons with their
passwords.

The Ramp Function

The ramp function provides a pressure increase from the ramp start pressure to a set
IPAP and EPAP pressure within a specified time. It can be adjusted in 5 min intervals
between 0-60 minutes. Algorithm calculations are not enabled during the ramp.
Humidifier
The humidifier function can be adjusted in 0 - 10 steps for additional humidification of
the air supplied to
the patient. Optimum temperature setting; depends on the ambient temperature and
humidity of your room. If the room temperature is low and / or the relative humidity is
high, a lower temperature setting to prevent excessive condensation in the patient hose;
If the room temperature is high and / or the relative humidity is low, a higher temperature
setting will be required for comfort.

20
Mask Off
When the mask comes out or if there is too much leakage, the device is put on hold and
when you start breathing again, the device starts working from the initial values.

SD Card Usage
The SD card must be up to 8 GB and with the notched side facing up, the device must
be plugged in and disconnected from the electrical connection. For approximately 5
years, this card keeps the device usage information and details can be viewed with the
YEL software. The device does not store any information during the time that the SD
card is not inserted.

4.2 Adjustable and Applicable Parameters

EPAP 3-35 cmH2O (Resolution 0.5 cmH2O)

IPAP 3-35 cmH2O (Resolution0.5 cmH2O)
Ramp 0-60 min Interval: 5 min
Humidifier 0 – 10 (0 Closed Position))
Mask off Standby Application
I Trigger 1-5 level
E Trigger 1-5 level
Number of Breath 4-30 breath /min
Inhalation Time 0.3 – 5 second
Rising Time 1-5 level
Screen Light 0 - 5 min Interval: 0.5 min (0: display light always on)
Screen Brightness 1-10 level
Ramp Pressure 3-EPAP cmH2O (Up to the set EPAP value)

Humidifier Setting Table (25 ˚C %37 humidity)

Level 1 30±1 ˚C Level 6 49±1 ˚C
Level 2 34±1 ˚C Level 7 53±1 ˚C
Level 3 38±1 ˚C Level 8 58±1 ˚C
Level 4 42±1 ˚C Level 9 62±1 ˚C
Level 5 46±1 ˚C Level 10 66±1 ˚C

21
5 USING THE YEL SLEEP BREATHING DEVICE
5.1Checking the YEL Sleep Breathing Device before Use
Always make the following checks before using the YEL Sleep Breathing Device:
1.Install a cleaned circuit or a new patient circuit in the YEL Sleep Breathing
Device.
2.Connect the YEL Sleep Breathing Device to the mains power supply.
3.Check the patient settings.
4.Turn on the YEL Sleep Breathing Device by pressing the start button on the
front panel. Make sure that the YEL Sleep Breathing Device is working.
5.Attach the mask and adjust it so that it fits well.
Make sure that the settings are made as recommended. The YEL Sleep
Breathing Device is ready for use.
6.The YEL Sleep Breathing Device works with the touch screen system and is
pressed for 3 seconds on the screen.
5.2 Switching the YEL Sleep Breathing Device (On and Off)
1. Make sure the power supply is connected. After 3 seconds the main screen
comes, when power supply is connected.
2. On the front panel, the device is operated immediately by touching the on / off
button on the left. When the winding is running, touch the “Back” button to return
to the start screen. Press the On / Off button again to stop the device.
5.3 Using the Menu
See Page 14-22.
5.4 Transferring Data between the YEL Sleep Breathing Device and PC
The YEL Software must be installed on the PC to see and display the patient data
correctly. It can be loaded with USB connection or SD card.
Data transfer is made according to the software operating instructions.
5.5 Using the Integrated Humidifier
The Humidifier is intended to humidify the patient air. Due to integrate with the device,
using without humidifier is not possible. If necessary to use without humidifier, set of
humidifier must be adjust to “0”.

Caution! To prevent water spillage, do not carry water with the appliance.

Release and Lock of Humidifier : To release humidifier chamber from the device pull
the chamber
backwards from the top or holding holes while holding the latch. You can fit the chamber
again by pushing to the slot. You should hear the clicks of the latch. If you do not hear
this voice this mean the humidifier is not properly fit. Provide lifting the latch by pressing
or push the humidifier forwards sharply.
Setting the Humidifier
Setting of the humidifier may varied depends on the ambient temperature, set pressure
and air flow. The patient can determine the most optimum setting and for this a
temperature value must selected to avoid accumulate excessive water in tube.Do not
touch the heater when the chamber is not attached.

22
5.6 Using with an External Battery and Lighter Cord
Only use the YEL Sleep Breathing Device with external battery recommended by the
manufacturer.
Should be used with lighter cord that provided by manufacturer, otherwise the device
and the patient may have problems.

6 PREPARING THE YEL SLEEP BREATHING DEVICE FOR USE

6.1 Installing the YEL Sleep Breathing Device
When using the YEL Sleep Breathing Device for the first time, follow the instructions
below:
1. Check that all main components and ordered accessories have been delivered (refer
to the packing note or the invoice, if available).
2. Ensure that the equipment is in good condition.
3. Check that the mandatory grey patient air filter is installed.

6.2 Placing the YEL Sleep Breathing Device

1. Place the YEL Sleep Breathing Device on a solid and flat surface on facing the
patient. The YEL Sleep Breathing Device should be placed lower than the patient in
order to prevent the device from falling on the patient, as well as preventing condensed
water to reach the patient.
2. Make sure that nothing can block the patient air inlet at the rear side of the YEL Sleep
Breathing Device

6.3 Connecting the YEL Sleep Breathing Device to the Power Source
1. Plug the power cord into the power inlet of the YEL Sleep Breathing Device.
2 .Connect the power cord into the power supply.
3. Connect the power cord to the power source. Do not use connecting cable.

6.4 Connecting the Patient Circuit

1. Connect the patient tube to the air outlet.
2 .Connect the other end of the patient tube to the mask. Make sure the leakage port is
available.

Mask Leakage Flow

The leakage from the mask should be at least 12 L/min at 4 cmH2O, to preventer-
breathing of exhaled air. The recommended mask leakage is 20-40 L/min at 10 cmH2O
pressure. This leakage may be achieved by:
. Small holes in the mask
. An adjoining ventilation valve
To achieve an applicable leakage Foras Medical Sleep Breathing Device Mask is
recommended.

23
Troubleshooting Table & Alarm Codes Table
Troubleshooting
Problem Solution

Mask leaks air Check the mask manual. Be sure to attach your mask correctly.

My mouth and / or nose is clogging
The air from the mask is high
The air from the mask is low
Humidifier is leaking water
The device alarms and stops when it is
running
The SD Card symbol is not active
The device does not give air, it does not
work
Device does not provide pressure settings
Check the humidity, if the current level is insufficient, try to use the
higher humidity setting.
Activate the ramp feature. For time and pressure, you can make the
appropriate adjustment by getting support from your supplier.
Check the ramp feature. If the ramp function is active, wait for the
ramp to expire.
Check the filling warning leaflet to ensure that you have filled the
humidifier
correctly. If the problem is not caused by the way of filling out,
unplug your device and contact your supplier.
Check that there is no mask off on the screen. Check the hose and
mask connections.
Remove and insert the SD card again when the device is in a power
cut position.
Unplug the device, reconnect it and keep it active by pressing the
On button for about 3 seconds. If the problem persists, contact your
dealer.
Check with the breathing circuit for air leaks in the YEL Sleep
Breathing Device. If the problem persists, contact your supplier.

Alarm Table
Alarm Format Definition Solution
Please check if there is electricity in the
main. If there is electricity, check the device
Three long beeps Power cut, device has been power cut.
connections with the adapter and plug it back
in.
When the mask off feature was active,
Mask off text on the
excessive leakage occurred in the device Check the mask, hose connections.
screen
and the device stopped.

7 MAINTENANCE
7.1 Cleaning the YEL Sleep Breathing Device
Patient connected parts and filter must be cleaned and replaced regularly to ensure
correct function of the YEL Sleep Breathing Device.
All replaced parts must be disposed of and recycled in accordance with the local
environmental regulations regarding the disposal of used equipment and waste.
To avoid electrical shock, disconnect the electrical supply to the YEL Sleep
Breathing Device before cleaning.
It is recommended that the YEL Sleep Breathing Devices should be maintained at
least once a year to verify the given values.
Do not immerse the YEL Sleep Breathing Device into any fluids.
. Always be careful when cleaning to ensure that you do not damage any equipment.
. Fluid must not be allowed to enter into the YEL Sleep Breathing Device.
. The time and date settings may not be retained if they are not plugged in for more than
a week. Therefore, make sure the time and date are correct before operating the device.
24
Main Unit
1. Switch off the YEL Sleep Breathing Device and disconnect the power supply.
2. Remove the patient circuits.
3. Detach the humidifier.
4. Disconnect all cables.
5. Clean the outside of the YEL Sleep Breathing Device using a lint-free cloth and a mild
detergent solution.
6. Reconnect cables and the patient circuit. Make sure all parts are dry before the YEL
Sleep Breathing Device is put into operation.

Humidifier
1. The humidifier of YEL should be cleaned regularly.
2. The humidifier can be released from the device by pushing to backwards of
device while holding the latch.
3. Upper lid of humidifier detached and under silicone gasket is removed;
4. Put the hot water in humidifier chamber up to the upper water limit against the
lime and the residue consisting in the YEL water chamber.
5. Add water to 15g citric acid. After waiting 30 minutes, clear by hand wash or
without detergent in the dishwasher in maximum 70 ° C. Use after thoroughly
dried.
6. Reassemble the humidifier placing the gasket and cover. Replace the humidifier
in case of damage
Technical Specifications : Dimensions (Width: 6mm, Length: 11,5mm, Height: 9mm),
Maximum water capacity 100ml, Polycarbonate Plastic housing,and Heater Aluminum
Base.
• Reassemble by placing the humidifier gasket and cover. In case of damage,
replace the humidifier.
• Continuously check the water in the humidifier tank. When the water is exhausted
according to the climate or region in which it is used, undesirable conditions may
occur as the patient's respiratory tract will dry.

Patient Circuit
The patient circuit should always be cleaned in accordance with the manufacturer’s
instructions.
Always replace the patient circuit with a new one when the YEL Sleep Breathing Device
is to be used by a new patient.
All parts that come into contact with the respiration gas must be cleaned as follows:
1. Place the dismantled parts in hot water containing washing-up liquid.
2 .Remove fouling with a brush.
3 .Rinse parts thoroughly under running hot water.
4 .Shake water out of all parts.
5 .Dry the parts completely.
6 .Store in dust-free location.
The patient circuit should be replaced regularly in accordance with the manufacturer’s
instructions. Check the patient circuit for damage regularly. In case of damage, replace
the circuit.

25
7.2 Patient Filter Replacement and Cleaning
The patient air filter is located on the back of the YEL Sleep Breathing Device.
Washable Filter (Grey)
Replace the washable filter at least once a year. Wash the filter at least once a week.
1. Wash the filter using warm water and a mild detergent.
2 .Rinse thoroughly.
3 .Dry the filter by squeezing it out in a towel. Do not wring the filter.
7.3 Regular Maintenance Control
The YEL Sleep Breathing Device should not require any regular maintenance
inspections if it is used
and maintained in accordance with the instructions in this manual.
Do not use the device and contact your responsible care provider for an
inspection of the device in the
event of:
. Unexpected patient symptoms during treatment.
. Unexplainable or sudden pressure, performance or sound changes during operation.
. Suspected damage to the device or power supply.
7.4 Service and Repair
The service and repair of the YEL Sleep Breathing Device must only be carried out by
authorized service personnel in accordance with Foras Medical service
instructions.Service inspections must always be carried out after any repair of the
device.
Authorized service workshops can order the YEL Sleep Breathing Device Service
Manual that contains all technical documentation required for the maintenance and
service of the YEL Sleep Breathing Device.
• The values given of The YEL Sleep Breathing Device must be verified at least
once a year by performing the necessary calibration and testing.
• Blower motor that used in the device needs to be replaced at 15.000 hours. This
time may be shortened in case of the filter is not clean and not replacement on
time and also extremely dirty and dusty using environment.
• The battery, located in the device that used as source of energy of clock and
alarm should be checked after every maintenance and repair. The battery must
be replaced if the device gives not any alarm in case of power failure or in case of
the clock is not operating normally. Batteries should be replaced at least once a
year.
7.5 Storing YEL Sleep Breathing Device
• Drain, clean and dry the humidifier before storing the YEL Sleep Breathing
Apparatus.
• Store the YEL Sleep Breathing Apparatus in its original box in a place that is not
suitable for the sun.
• Storage conditions are between -20 ° C and 50 ° C.

26
7.6 Disposal of YEL Sleep Breathing Apparatus
All accessories and replacement parts of the YELSleep Breathing Apparatus must be
disposed of and disposed of in accordance with local environmental regulations for
equipment and waste. All accessories and all replaced parts of the YEL Sleep Respirator
must be disposed of and disposed of in accordance with local environmental regulations
for equipment and waste. The European Directive 2012/19 / EU on Waste Electrical and
Electronic Equipment (WEEE) stipulates that electrical and electronic equipment must
be collected and disposed of separately from other unsorted municipal waste. The
garbage bin symbol with diagonal lines on it indicates that a separate collection is
required.
8 SPECIFICATIONS OF YEL SLEEP BREATHING DEVICE
8.1 Technical Characteristics
Technical Qualities of Cpap Technical Qualities of AutoCpap
Working Voltage : 24 Volt DC Working Voltage : 24 Volt DC
Pressure : 3-20 cmH2O EPAP- Pressure : 3-20 cmH2O
Dimensions : 14X22X11cm IPAP Pressure : 3-20 cmH2O
Dimensions : 14x22x11cm
Technical Qualities of Bipap Technical Qualities of AutoBipap
Working Voltage : 24 Volt DC Working Voltage : 24 Volt DC
EPAP Pressure : 3-25 cmH2O Epap Min Pressure : 3-24 cmH2O
IPAP Pressure : 3-25 cmH2O Epap Max Pressure : 3-24 cmH2O
Inhalation Trigger : Yes Pressure Support : 1-22 cmH2O
Exhalation Trigger : Yes Dimensions : 14x22x11cm
Dimensions : 14x22x11 cm Set Breath Number : 6
Set Breath Number : 6
Technical Qualities of Bipap S/T Technical Qualities of Bipap S/T
Avaps
Working Voltage : 24 Volt DC Working Voltage : 24 Volt DC
EPAP Pressure : 3-35 cmH2O EPAP Pressure : 3-35 cmH2O
IPAP Pressure : 3-35 cmH2O Ipap Min-Max Prs. : 3-35 cmH2O
Inhalation Trigger : Yes Inhalation Trigger : Yes
Exhalation Trigger : Yes Exhalation Trigger : Yes
Breath Rate : Adjustable Breath Rate : Adjustable
Inspiration Time : Adjustable Inspiration Time : Adjustable
Rise Time : 1-5 Target Volume : Adjustable
Technical Qualities of ASV Technical Qualities of Elite
Working Voltage : 24 Volt DC Working Voltage : 24 Volt DC
EPAP Pressure : 3-34 cmH2O EPAP Pressure : 3-35 cmH2O
Prs. Sup Min-Max : 1-32 cmH2O IPAP Pressure : 3-35 cmH2
Inhalation Trigger : Yes Inhalation Trigger : Yes
Exhalation Trigger : Yes Exhalation Trigger : Yes
Breath Rate : Adjustable Breath Rate : Adjustable
Inspiration Time : Adjustable Target Volume : Adjustable
27
The differences between the models are evaluated in the following table.
Differences of Devices
Devices Humidifier Ramp IPAP EPAP I.trg E.trg Rise Mask Target Pressure EPAP IPAP
time off Volume Support Min. Max.
Cpap * *
AutoCpap * * * * *
Bipap * * * * * * *
BipapAuto * * * * * * * * * *
Bipap S/T * * * * * * * *
Bipap S/T Avaps * * * * * * * * * *
ASV * * * * * * * * *
Elite * * * * * * * * * * * *
Dynamic Short-term Pressure Accuracy; (According to ISO 80601-2-70: 2015)
Maximum Flow Rate: (in accordance with ISO 80601-2-70: 2015)
Parameter Test Pressure
IPAP Presure (cmH2O) 7 12 19 25

EPAP Pressure(cmH2O) 3 8 15 21

Measured IPAP Pressure (cmH2O) 7.1 12 18.9 25

Measured EPAP Pressure (cmH2O) 2.9 7.9 14.8 21.1

Flow(LPM) 86.8 155.7 160.1 154.7

8.2 Environmental Characteristics

Operating Temperature: +5 ˚C - +40 C
Storage Temperature: -20 ˚C to +50 C
Relative Humidity (operation and storage): 15% to 95% (non-condensing)
Atmospheric Pressure: 70 kPa - 106 kPa (700 mbar - 1060 mbar)

Keep dry during transport.

8.3 Physical Properties

Dimensions: 16.5 x 16.5 x 13.5 cm
Weight (only device): 1.127 kg

8.4 Electrical Properties

DC Power Consumption; 24 VDC, 3 A
Number of Poles: 1
Declared Voltage (Un): 230 VAC
Declaration Operating Voltage (Ue): 230 VAC
Declaration Current (In): 0.5 A
Declaration Frequency (fn): 50 Hz
Fuse: The device has no user replaceable fuse.

Compliance with Standards;

The device is designed to comply with the following standards.
IEC 60601-1 Medical Electrical Equipment- General Requirements for Safety of Medical
Electrical Equipment IEC 60601-1-2 Medical Electrical Equipment-General

28
Requirements for basic Safety and essential performance-Collateral Standard:
Electromagnetic disturbances- Requirements and tests
IEC 60601-1-8 AMD 1 Medical Electrical Equipment – Part 1-8: General Requirements
for basic Safety and essential performance – Collateral Standard: General
Requirements, tests and guidance for alarm systems in medical Electrical Equipment
and medical Electrical systems
IEC 60601-1-6 Medical Electrical Equipment – Part 1-6 General Requirements for basic
Safety and essential performance - Collateral Standard : Usability
IEC 60601-1-10 Medical Electrical Equipment – Part 1-10 General Requirements for
basic Safety and essential performance - Collateral Standard- Requirements for
Development of physiologic closed-loop controllers
IEC 60601-1-11 Medical Electrical Equipment – Part 1-11 General Requirements for
basic Safety and essential performance Collateral Standard : Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare
environment
ISO 80601-2-70 Medical Electrical Equipment-Particular requirements for basic safety
and essential performance of sleep apnoea breathing therapy equipment
ISO 80601-2-74 Medical Electrical Equipment- Particular requirements for basic safety
and essential performance of respiratory humidifying equipment

Residual Risks
Risk Analysis is a statement of residual risks from the evaluation table.
1a) Risk of Line Voltage : Operating with any power source without reading the User
Manual
1b) Voltage Leakage to The Patient: Failure to do 60601-1 discharge tests to the patient
for voltage leakage
1c) Electric Shock: Contact, leakage current and patient leakage tests are not performed
1d) Electric Field: Non-compliance with the electrical information in the book
1e) Magnetic Field/Radiation: Use outside the declared area in the User Manual
2a) Ionizing Radiation: Use outside the declared area in the User Manual
2b) Non-Ionizing Radiation: Use outside the declared area in the User Manual
3a) High Temperature: Incorrect installation of sensor
3b) Low temperature: Incorrect installation of sensor
4a) Lower the Device: Lower the device too high
4b)High sound emission of the device: Failure to use critical components passing testing
4c) Vibration: Failure to produce according to the instructions of the User Manual
4d) Torsion, shear and strain : Failure to observe the operating instructions
4e) Acoustic Energy: Failure to observe the operating instructions
4f) Injection of liquid into the device: Not to be used according to the User Manual
5a) Gases formed by chemical waste: Failure to read the User Manual
5b) Medical Gases: Failure to read the User Manual

29
5c) Additives:Failure to follow the instructions and not to take the device to the
authorized service
5d) Residue on the device: Failure to read the User Manual
5e) Bacteria, viruses and other agents: Failure to read the User Manual
5f) Reuse or Cross infection: Failure to read the User Manual
6a) Toxicity : Using non-biocompatibility masks
6b) Allergy and Irritation: Using non-biocompatibility masks
7a) Cleaning and Contaminants: Failure to observe the manual
8a) Incorrect or Improper Function: Failure of final checks
8b) Incorrect Measurement: Not using the Test Form
8c)Incorrect Data Transfer: Failure to pay attention to the device screen or read the User
Manual
8d) Model Differences: Failure to observe the User Manual
9a) Misuse due to lack of attention: Failure to understand the User Manual
9b) Causing memory weakness: Failure to observe the User Manual
9c) Damage to the patient from its use: Not to use as described in the User Manual
9d) Lack of Knowledge: Failure to read the User Manual or get educated
9e) Frequent violations: Read the User Manual, no training,and habits
9f) Information about device accessories: Failure to read the User Manual
9g)Insufficient information before operating the device: Failure to read the User Manual
9h)Risks arising from long-term use: Failure to read the User Manual
9i)Side effects and insufficiency of warnings: Failure to follow the User Manual, and
symbols on the label
9j) Flammability: Failure to read the User Manual
9k) Extremely moist environments: Failure to read the User Manual
9l) The use at dusty environments: Failure to read the User Manual
9m)The use of children, pregnant and lactating women: Failure to read the User Manual
9n) Water entering the device: Failure to read the User Manual
10a)Problems from Critical Materials: Failure to follow the instructions of the User
Manual
10b) Adapter problems: Failure to read the the User Manual, no attention to the label
11a) Unsuitable raw material: Failure to follow the instructions of the User Manual
11b) Unsuitable semifinnished products: Failure to follow the instructions of the User
Manual
12a) Montage error: Failure to follow the instructions of the User Manual
12b) Plastic Production Error: Failure to act on the list of the User Manual
12c) Failure to program the device: Inattention of staff
12d) Semi-finished products: Production of non-trained personnel
13a) Adverse Events: Not knowing the responsibilities and authorities
30
13b) Recalls: Not knowing the responsibilities and authorities
13c) No Traceability: Prepared records and forms not to be filled
14a) Packaging: Failure to follow the procedure
14b) Missing material in the package: Failure to pay attention to the User Manual and
label
15a) Labeling: Failure to follow the instructions of the User Manual
16a) Lack of operational instructions: Failure to read the User Manual
16b) Improper use of accessories: Failure to read the User Manual
16c) What to do before operation: No reading of the User Manualor no training
16d) Long-term use: No reading of the User Manual or no training
16e) Device failure or malfunction: Not reading the User Manual, not paying attention to
the labels
16f) Disposal of the appliance: Failure to read the User Manual
16g) Not knowing the performance characteristics: No attention to label or the User
Manual
17a) Lack of side effects and warnings: Failure to read the User Manual
18a)Software not working: Failure of final checks
18b) Processor failure: No input controls, failure to follow instructions
18c) Sensor Errors: Failure of final checks
18d) Software communication problems: Non-compliance with production instructions
18e) Sensor Pressure does not meet: Failure to recognize the operation of the device
18f) Operation of the device outside the intended use: Device not tested
18g) Stopping the running device: No mask off control in test form
19a) Device does not work properly after service: Failure to follow the instructions of the
User Manual
19b) The problem of the device from the service: No communication with the customer
20a) The weather abduction of the mask: Failure to read the User Manual
20b) My mouth and / or nose is clogging: Failure to read the User Manual
20c) Producing high air volume from Device: Failure to read the User Manual
20d) Producing low air volume from Device: Failure to read the User Manual
20e) Leaking Water from Humidifier: Failure to read the User Manual
20f) Continuous alarm of the device: Failure to read the User Manual
20g) Unable to use SD card: Failure to read the User Manual
20h) The device does not produce air, does not work: Failure to read the User Manual
20i) The device's screen does not work: Failure to follow the instructions of the User
Manual
21a) Storage: Failure to read the User Manual

31
 Related Directives
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

IEC 60601-1Classification;
• Type of protection against electric shock: Class II
• Degree of protection against electrostatic impact: Type BF
• Degree of protection against impacts and water ingress: IP 21

Electromagnetic Compatibility (EMC)

YEL Sleep Breathing device is suitable for use in the electromagnetic environment
indicated in the table. User should ensure that the device is used in such environment.

Protection Test IEC 60601 Test Level Compatibility Degree Electromagnetic Environment- Guide
Floors should be wood, concrete or ceramic
Electrostatic Discharge (ESD) ± 8 kV contact ± 8 kV contact tile. If floors are covered with synthetic
IEC61000-4-2 ± 15 kV air ± 15 kV air material, the relative humidity should be at
least 30%.
Electrical fast transient/ burst IEC ±2 kV for power supply lines ± 2 kV Mains power quality should be that of a typical
61000-4-4 ±1 kV for input/output lines ±1 kV for input/output lines commercial or hospital environment

Surge ±1 kV differential mode ± 1 kV differential mode Mains power quality should be that of a typical
IEC 61000-4-5 ±2 kV common mode ± 2 kV common mode commercial or hospital environment

<5% UT (>95% dip in UT) 0% UT (100% dip in ut ) 0.5 Mains power quality should be that of a typical
for 0.5 cycle cycle - 20 ms commercial or hospital environment.

Voltage dips and short 40% UT (60% dip in UT) 0% UT (60% dip in ut ) 1 If the user of the device requires continued
interruptions, immunity related to for 5 cycles cycle- 100 ms operation during power mains interruptions, it
voltage changes is recommended that the device be powered
IEC 61000-4-11 70% UT (30% dip in UT ) for 70% UT (30% dip in ut ) 25 from an uninterruptible power source.
25 cycles cycles - 500 ms;

<5% UT (>95% dip in UT ) 5 0% UT (95% dip in ut ) 5

seconds seconds - 250 cycles
Power frequency magnetic fields should be at
Power frequency magnetic field 30 A/m (50 Hz, 60Hz) 30 A/m levels characteristic of a typical location in a
IEC 61000-4-8 typical commercial or hospital environment.

Portable and mobile RF communications

equipment should not be used closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.Adviced separation distance
Conducted 3 Vrms 150 kHz – 80 MHz ± 3 Vrms equation;
RF IEC 61000-4-6 d= 1.2 √P
d= 1.2 √P 80MHz - 800 MHz
d= 2.3 √P 800MHz-2.5GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).

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 Emmision Test Compatibility Electromagnetic Environment- Guidance
The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
RF emmissions CISPR 11 Group 1 in nearby electronic equipment
The device is suitable for use in all establishments, including domestic
RF emmisions CISPR Class B establishments and those directly connected to the public low-voltage
network that supplies buildings used for domestic purposes.
Harmonic Emissions IEC 61000-3-2 Class A
Voltage Fluctiations-Flicker Emissions
(IEC 61000-3-3) Complies

Software Information;
Device software is included in class A software security class. Class A: No injury or
health hazards. The version definition is used for the traceability of software updates.
The update operations are performed on all models. The current version of the YEL
Devices are 1.1. The “user time” reset and calculation feature has been added to this
version according to user demands. The device version can be accessed from the
device's info menu.

Foras Bilg. Elekt. Medikal San. Tic. Ltd. Şti

Ostim O.S.B. Mahallesi 1269.Cadde No: 35
Yenimahalle – ANKARA

MADE IN TURKEY
www.foras.com.tr / info@foras.com.tr
Tel: +90 312 395 77 66
Faks: +90 312 395 77 67

Notified Body: Kiwa Belgelendirme Hizmetleri A.Ş.

Address: İTOSB 9. Cadde No: 15
Tepeören mevkii / Tuzla – İSTANBUL - TÜRKİYE
e-mail: info@kiwa.com.tr

Document no : YEL001
Revision : 02
Revision Date : 02.09.2019
Publish Date : 03.09.2019

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