Curative FLOTON ST20 User manual

FLOTON ST20 USER MANUAL
Sleep Apnea Breathing Therapy Device
ENGLISH

Floton Auto CPAP
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SYMBOL KEY 6
CAUTIONS AND WARNINGS 7
CAUTIONS! 7
WARNINGS! 8
LIABILTY 9
INTRODUCTION 10
INTENDED USE 10
CONTRAINDICATIONS 10
DESCRIPTION OF THE DEVICE AND HUMIDIFIER 11
FLOTON ST20 11
FRONT AND BACK VIEW 12
CONTROL PANEL 13
HUMIDIFIER 14
ACCESSORIES 15
ACCESSORIES AND PARTS 16
CONNECTING THE SYSTEM 16
HUMIDIFIER 17
MASK 17

Floton Auto CPAP
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PARAMETERS, KEYS AND DISPLAY 18
PARAMETERS 18
KEYS 19
ON/OFF KEY 19
INPUT KEYS 19
RETURN KEY 19
DISPLAY 20
MONITORING DISPLAY 20
MODE DISPLAY (ST/T/S/APCV/CPAP) 20
RAMP AND AUTO DISPLAY 20
FUNCTIONS THE DEVICE 21
I-SLOP (SPEED OF RISING PRESSURE) 21
E-SENS (SENSITIVITY OF EXPIRATION TRIGGERING) 21
SPONTANEOUS MODE: S MODE 21
TIMED MODE : T MODE 21
CPAP MODE 21
ST MODE / SPONTANEOUS-TIMED MODE 22
AUTOMATIC MODE 22
PRESSURE CONTROL MODE: APCV (ASSISTED PRESSURE CONTROL VENTILATION) 22
RAMP FUNCTION 22
ALARMS 23
POWER FAILURE 23

Floton Auto CPAP
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CHECKING THE POWER FAILURE ALARM 23
LEAKAGE 23
CLEANING AND MAINTENANCE 24
CLEANING THE FLOTON ST20 24
CHANGING THE FLOTON ST20 CLOCK BATTERY 24
CLEANING THE HUMIDIFIER 24
HUMIDIFIER FUSE 25
CHANGING FILTER 25
TROUBLESHOOTING 26
SERVICE 29
SPECIFICATIONS 29
DISPOSAL 30
QUALITY WARRANTY ERROR! BOOKMARK NOT DEFINED.
ELECTRIC MAGNETIC INFORMATION 31
GUIDANCE AND MANUFACTURERS DECLARATION OF ELECTROMAGNETIC IMMUNITY FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE SUPPORTING 31
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE FLOTON AUTO CPAP 34

Floton Auto CPAP
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DISCLAIMER OF WARRANTY AND LIMITATION OF CURASA ERROR! BOOKMARK NOT DEFINED.
CONTACT DETAILS 35

Floton Auto CPAP
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SYMBOL KEY
Attention!
Consult
accompanying
documents
Manufacturer
Date of
manufacture
Serial
number
Type B
applied part
Class II
Double
insulated
The device,
accessories
and the
packaging
have to be
disposed
correctly at
the end of
the usage.
Please
follow Local
Laws or
Regulations
for disposal
DC Power
Standby

Floton Auto CPAP
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CAUTIONS AND WARNINGS
CAUTIONS!
This device is restricted to sale by or on the order of a physician.
Do not use the device before the recommended therapeutic pressure is prescribed by a physician.
The device should be used with the external AC/DC adapter provided by manufacturer. Use of other AC/DC adapters may
damage the device or cause fire and electric shock hazards.
To prevent water entering the breathing circuit connection on the mask, the device must always be positioned below the
head.
Do not use the device at room temperatures above 35°C. If the device is used when temperature is above 35°C then the
temperature of the airflow may exceed 41°C, which could cause thermal irritation or injury to the patient’s airway.
Do not place the device near any items (curtains, bedding, couch) or heating devices (air conditioners, radiators, vents) that
may disrupt the airflow around the device.
Before carrying or packing the device you must empty the humidifier of water
The device should only be used with marked parts provided or recommended by your authorized dealer.
Check the alarm function regularly and if the device has not been used for a long time please check the power failure alarm
before use. If the Power failure alarm is invalid the device must be left in stand-by mode or left running for at least 12 hours
before checking the alarm again to make sure it is functioning normally.
If the device has recently been placed in a very hot or very cold environment, wait for 2 hours to allow temperature to
normalize before switching the device on.
The device can only be operated at temperatures between 5°C and 35°C.

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WARNINGS!
The device cannot be used whilst mobile.
This device is for adult use only and not for use by children or persons with certain disabilities who would require supervision
in order to use the device safely.
The device cannot be used for life support.
Do not use the device in the presence of nitrous oxide or flammable anesthetic mixtures in combination with oxygen or air.
In the event that the device noise level becomes higher than normal, the devices output of air becomes too hot, the device
has an abnormal smell or if any part of the device becomes broken, stop using it immediately contact an authorized dealer.
The device can only be switched off completely when the power supply is disconnected from the wall socket.
Make sure the exhalation opening in the mask or swivel is open so that the exhaled air containing CO2can escape.
To avoid rebreathing do not wear the mask for more than 3 minutes when the device is not switched on. (Note. At low
pressures the airflow may not be sufficient to remove all exhaled gas (CO2) therefore some rebreathing may occur.) Relevant
to curative?
The air inlet of the device should never be covered.
To avoid electric shock:
oDo not use the device if the device if the casing or cables are damaged.
oDo not use the device of it has been dropped in water.
oKeep device away from water.
oBefore cleaning the device pull the power plug out of the socket.

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This device is for single patient use only and should not be shared with other patients.
If the patient experiences mucous membrane dryness in the nose and pharynx, frontal sinus trouble, earache, a running nose
or skin sensitivity etc. you should consult your physician immediately.
Operation of the device may be adversely affected by:
-Electromagnetic fields exceeding the level of 3V/m in the test conditions of EN 60601-1-2
-The operation of high frequency (diathermy) equipment.
-Defibrillators, or short wave therapy equipment
-Radiation (e.g., X-ray, CT)
-Magnetic fields (e.g., MRI).
-Do not sterilize the device with high pressured steam
LIABILTY
The manufacturer shall not be held liable for any damages in case of:
Tampering, modifying, adding expansion features or repair by persons who have not been authorized by the manufacturer.
Using accessory or spare parts that are not recommended by us, or not officially registered.
Using the device in a way that was not instructed in the manual.

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INTRODUCTION
INTENDED USE
The Floton ST20 respiratory sleep apnea breathing therapy device is for use by patients with sleep apnea or hypopnea syndrome to
reduce the frequency of sleep apnea, hypopnea and increases nocturnal SaO2.
It provides a stable continuous positive airway pressure whilst the humidifier provides warm and humid air which helps to avoid
nose and airway dryness increasing the comfort for the patient.
The therapeutic pressure is prescribed by a physician according to patient’s condition.
CONTRAINDICATIONS
The use of positive airway pressure may be contraindicated if the patient suffers from the following pre existing conditions:
Pneumothorax
Pneumomediastinum (Air in mediastinum)
Cerebrospinal fluid leakage
Pneumocephalus
Extremely low blood pressure or shock
Confusion or coma resulting in the patient not been able to co-operate with or accept the mask
Excessive secretions in the airway as well as not coughing effectively and weak voluntary breathing.

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DESCRIPTION OF THE DEVICE AND HUMIDIFIER
FLOTON ST20

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FRONT AND BACK VIEW
Front
Back
Attention! The data transmission interface is only used during production or service when transmitting data to RS232 or
the USB of a PC.
Equipment connected to the analog or digital interfaces must comply with the respective IEC standards (e.g. IEC 950 for data
processing equipment and IEC 60601-1 for medical equipment). All configurations shall comply with the current version of the
standard for SYSTEMS IEC 601-1-1. If you are in doubt consult the technical service department or your local representative. RS232
and the USB port are only for technical use.

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CONTROL PANEL

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HUMIDIFIER
Warning! The humidifiers DC power jack can only be used to connect to the device with the provided power cable for
the humidifier. Do not connect it with the other devices.

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ACCESSORIES
Power supply cord and power supply adapter
Connecting tube
Hose with a pressure tube
WARNING! The device should be used only with the external AC/DC adapter provided by manufacturer. Use of other
AC/DC adapters may cause damage to the device and cause fire and electric shock hazards.
MAX. water line

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ACCESSORIES AND PARTS
1 Floton ST20 device (including one fine filter)
1 Humidifier
1 Power supply adapter (including one power supply cord for AC input)
1 Hose with an inserted pressure tube
1 Mask (connector diameter 22mm)*
1 Headgear (for use with mask)*
1 Connecting tube
Note: Items with * can be supplied by the manufacturer or purchased from other vendors that are CE-marked.
CONNECTING THE SYSTEM
Check whether the device is damaged and if any accessories or parts are missing.
Put the device on a stable and even surface. Make sure the air inlet in the back of the device is not blocked.
Connect the power supply adapter with the power supply cord and then connect the DC output of adapter with DC power
jack on the back of the device.
Connect the two ends of the hose to the device’s air outlet and mask separately.
Connect the pressure tube to the pressure port in the device.
Connect to the power supply. Power supply adapter: AC input voltage range: AC 100-240V (50/60Hz); DC output: 24VDC2.5A
Max. When the device is on the power indicator light will illuminate and the display will show the preset parameters.

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HUMIDIFIER
Before the first use of the Floton ST20 humidifier please clean it thoroughly.
When filling the humidifier with water please disconnect it from the device
Fill the Floton ST20 humidifier with purified or distilled water only. The water must be cool, contain no other additions and
be below the maximum water line.
The temperature range of the humidifier can be adjusted according to patient’s requirement.
When humidifier is connected correctly and the device is turned on and is delivering airflow, the humidifier automatically
heats and the indicator will light green. When it reaches the set temperature the indicator light will switch off. Use the knob
to adjust the heating level.
MASK
For information on use of the mask please refer to separate instructions provided with the mask.

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PARAMETERS, KEYS AND DISPLAY
PARAMETERS
Function
Introduction
Range
IPAP
Inspiratory Positive Air Pressure
4 to 20cmH2O [0.5 cmH2O per step]
EPAP
Expiratory Positive Air Pressure
4 to 20cmH2O [0.5 cmH2O per step]
VT
Tidal Volume
N/A
BPM
Breaths per minute
5 to 40, 1bpm per step
Leak
Leakage Volume per minute
N/A
I-SLOP
Speed of rising pressure
1 to 6, 1 per step
E-SENS
Sensitivity of expiration triggering
1 to 6, 1 per step
MODE
Operation mode
APCV, S, T, ST, CPAP
IE%
The percentage of inspiration time in a respiration cycle,
applicable with T or ST mode
10% to 80% - 1% per step
RAMP
Ramp Time
0 to 60min, 1min per step
AUTO
Automatic operation mode
ON/OFF

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KEYS
ON/OFF KEY
Press the key down gently for about 1-2 seconds to turn on the device.
When the device is turned on the background light of LCD display will be illuminated. It will be turned off if no any action is
performed within 5 seconds. When the Power supply is plugged in the device is in stand-by mode. The power indicator will be
continuously on when the device is in stand-by mode.
Device On/Off means that motor is On or Off.
Power On/Off means that power supply is On or Off.
INPUT KEYS
Input keys are used for selecting functions and adjusting the parameters of a given function.
RETURN KEY
Return key is used for accessing edit mode and confirming changes of parameters.
To access edit mode to adjust parameters press the key once so that the editing function field blinks.
With the input keys change the value of the selected parameter.
Press key again to confirm and move to next parameter automatically.

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DISPLAY
MONITORING DISPLAY
MODE DISPLAY (ST/T/S/APCV/CPAP)
RAMP AND AUTO DISPLAY
Warning! IPAP cannot be set lower than
EPAP.
When CPAP is enabled, then IPAP and
EPAP are limited to 20cmH2O.
Warning! High EPAP pressure could
cause discomfort to the patient.
Carefully evaluate the patient if you set
the EPAP level above 15cmH2O.