Respirox E-20A User manual

English
Respirox®E-20A System
User Manual
0123

E-20A System User Manual V2.11
English
Table of Contents
1. Symbols ···································································································· 1
1.1 Control Buttons·················································································· 1
1.2 Device Symbols·················································································· 1
2. Warning, Caution and Important Tip ·································································2
3. Intended Use ······························································································ 2
4. Contraindications ························································································· 3
5. Specifications······························································································ 4
6. Available Therapies······················································································· 5
7. Glossary ···································································································· 6
8. Model ······································································································· 7
9. Package Contents························································································· 8
10. System Features························································································· 9
11. First Time Setup························································································10
11.1 Placing the Device············································································10
11.2 Installing the Air Filter and Filter Cap·····················································11
11.3 Connecting to Power·········································································11
11.4 Assembling the Tube and Mask ····························································12
11.5 Using Oxygen with the Device ·····························································13
11.6 Inserting the SD Card (Only for the device that equipped with SD card)··········13
11.7 Using the SpO2 Kit ···········································································14
11.7.1 Connecting the SpO2Kit to the Main Device ··································14
11.7.2 Removing the SpO2Kit from the Main Device·································15
11.8 Using the H60 Heated Humidifier ·························································17
11.9 Starting Treatment ···········································································17
12. Routine Use ·····························································································17
12.1 Connecting the Tube·········································································17
12.2 Adjusting the Tube ···········································································17
12.3 Turning on the Airflow ·······································································17
12.4 Heating the Water in the Humidifier ······················································17
12.5 Using the Ramp Button······································································18
12.6 Turning the Device Off·······································································18
13. Navigating the Patient Menu·········································································19
13.1 Steps to Navigating the Patient Menu ····················································19
13.1.1 Accessing the Main Interface ····················································19
13.1.2 Bringing up the Initial Setup Interface ·········································19
13.1.3 Accessing the Setup Interface ···················································19
13.1.4 Selecting Options···································································20
13.1.5 Adjusting Options ··································································20
13.1.6 Confirming Adjustments ··························································20
13.1.7 Turning Pages·······································································21
13.1.8 Exiting the Patient Menu··························································21
13.2 Options of the Patient Menu and Corresponding Descriptions ·······················22
14. Alert ······································································································23
15. Cleaning and Disinfection·············································································24
15.1 Cleaning the Mask and Headgear ·························································24
15.2 Cleaning the SpO2Kit········································································24
15.3 Cleaning the Water Chamber of the Humidifier·········································24
15.4 Cleaning the Enclosure ······································································24
15.5 Cleaning the Tube ············································································24
15.6 Replacing the Air Filter ······································································25
15.7 Disinfection ····················································································25
16. Traveling with the Device·············································································26

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17. Transferring the Device to Another Patient························································27
18. Reordering·······························································································27
19. Technical Support ······················································································27
20. Disposal··································································································27
21. Troubleshooting ························································································28
21.1 Common Problems in Patients and Corresponding Solutions·························28
21.2 Common Problems in the Device and Corresponding Solutions ·····················30
22. EMC Requirements·····················································································31
23. Limited Warranty·······················································································36

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1. Symbols
1.1 Control Buttons
Ramp Button
Mute Button
Knob
1.2 Device Symbols
Follow Instructions for Use
Operating Instructions
Type BF Applied Part (mask)
Class II (Double Insulated)
AC Power
DC Power
IP22
≥ 12.5 mm Diameter, Dripping (15°tilted)
Hot Surface
No SpO2Alarm
Serial Number of the Product
Manufacturer
EC REP
Authorized Representative in the European Community
European CE Declaration of Conformity
SD Card
Water Filling Prohibited Here
Water Inlet
Directional Indicator for Removing the Water Inlet Cap
Directional Indicator for Screwing the Water Inlet Cap

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2. Warning, Caution and Important Tip
WARNING!
Indicate the possibility of injury to the user or operator.
CAUTION!
Indicate the possibility of damage to the device.
IMPORTANT TIP!
Place emphasis on an operating characteristic.
Warnings, Cautions, and Important Tips appear throughout this manual as they apply.
3. Intended Use
The E-20A system is a CPAP (Continuous Positive Airway Pressure) device designed for the
treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home.
The device is to be used only on the instruction of a licensed health care professional. Your
home care provider will make the correct pressure settings according to your health care
professional’s prescription.
Several accessories are available to make your OSA treatment with this device as convenient
and comfortable as possible. To ensure that you receive the safe, effective therapy prescribed
for you, use only Ece accessories.
WARNINGS!
•This device is intended for adult use only.
•This device is not intended for life support.
•The instructions in this manual are not intended to supersede established medical protocols.
• Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may
cause unacceptable risk to the patient or damage to the device or MR medical devices. The
device and accessories have not been evaluated for safety in an MR environment.
• Do not use the device or accessories in an environment with electromagnetic equipment such
as CT scanners, Diathermy, RFID and electromagnetic security systems (metal detectors) as it
may cause unacceptable risk to the patient or damage to the device. Some electromagnetic
sources may not be apparent, if you notice any unexplained changes in the performance of this
device, if it is making unusual or harsh sounds, disconnect the power cord and discontinue use.
Contact your home care provider.
CAUTION!
•This device is restricted to sale by or on the order of a physician.
IMPORTANT!
• Read and understand the entire user manual before operating this system. If you have any questions
concerning the use of this system, contact your home care provider or health care professional.

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4. Contraindications
Studies have shown that the following pre-existing conditions may contraindicate the use of
positive airway pressure therapy for some patients:
Absolute Contraindications:Pneumothorax, mediastinal emphysema; cerebrospinal fluid
leak, traumatic brain injury, or pneumocephalus; shock caused by a variety of conditions before
treatment; active epistaxis; upper gastrointestinal bleeding before treatment; coma or impaired
consciousness making the use of mask during therapy impossible; giant vocal fold polyp, etc.
Relative Contraindications: Severe coronary heart disease complicated with left ventricular
failure, acute otitis media, excessive respiratory secretions and weak cough, weak spontaneous
breathing, nasal or oral tracheal intubation and tracheotomy, severe nasal congestion caused
by a variety of conditions, lung bullae, and allergies to breathing masks, etc.
The following side effects may occur during treatment:
- Dryness of the mouth, nose and throat
- Abdominal bloating
- Ear or sinus discomfort
- Eye irritation
- Skin irritation due to the use of a mask
- Chest discomfort
IMPORTANTS!
•An irregular sleep schedule, alcohol consumption, obesity, sleeping pills, or sedatives may
aggravate your symptoms.
• Please use the mask which meets ISO17510:2015.
CAUTION!
•Contact your health care professional if symptoms of sleep apnea recur. Contact your health
care professional if you have any questions concerning your therapy.

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5. Specifications
Device Size
Dimensions: 170 mm × 180 mm × 118 mm, or 290 mm × 180 mm × 134 mm (with the
humidifier)
Weight: 1.5 kg, or 2.5 kg (with the humidifier)
Product Use, Transport and Storage
Operation Transport and Storage
Temperature: 5°C to 35°C (41˚F to 95˚F) -25°C to 70°C (-13˚F to 158˚F)
Humidity: 15% to 93% Non-condensing 15% to 93% Non-condensing
Atmospheric Pressure: 760 to 1060 hPa 760 to 1060 hPa
Mode of Operation
Continuous
Work Mode
CPAP, Auto
SD Card
The SD card can record patient data and fault information.
AC Power Consumption
100 - 240 V AC, 50 / 60 Hz, 2.0 A max
Main Device offer to USB Communications Port
5 V 2.0 A
Main Device offer to Humidifier
24 V 1.5 A
Type of Protection Against Electric Shock
Class II Equipment
Degree of Protection Against Electric Shock
Type BF Applied Part
Degree of Protection Against Ingress of Water
IP22
Pressure Range
4 to 20 hPa (in 0.5 hPa increments), ≤30 hPa under single fault conditions.
Pressure Display Accuracy
± (0.5 hPa＋4%)
Static Pressure Stability
± 0.5 hPa
Ramp
The ramp time ranges from 0 to 60 minutes.

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Sound Pressure Level
< 30 dB, when the device is working at the pressure of 10 hPa.
Sound Power Level
< 38 dB, when the device is working at the pressure of 10 hPa.
Maximum Flow
Test Pressures (hPa)
4
8
12
16
20
Measured Pressure at the
Patient Connection Port (hPa)
3
7
11
15
19
Average Flow at the Patient
Connection Port (L/min)
80
92
91.5
91
96
SpO2
Range: 0 ～100%
The margin of error for SpO2between 70% and 100% is ± 3%. No strict accuracy requirements
for SpO2below 70%.
Pulse Rate
Range: 40 ～240 BPM
Margin of Error: ± 3%
Wavelengths
Red: 663 nanometers
Infrared: 890 nanometers
Maximal Optical Output Power
Less than 1.5 mw maximum average.
Tube
Length: 6 ft. (1.83 m)
The Form and the Dimensions of the Patient Connection Port
The 22 mm conical air outlet complies with ISO 5356-1.
6. Available Therapies
The device delivers the following therapies:
CPAP – Delivers Continuous Positive Airway Pressure; CPAP maintains a constant level of
pressure throughout the breathing cycle. If your health care professional has prescribed ramp
for you, you can press the Ramp Button to reduce the pressure and then gradually
increase the pressure to the therapeutic pressure setting so that you can fall asleep more
comfortably.
Auto – Delivers CPAP therapy and provides an air pressure no less than the prescribed one
based on the patient’s needs.

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7. Glossary
Apnea
A condition marked by the cessation of spontaneous breathing.
Auto-CPAP
Adjust CPAP pressure automatically to improve patient comfort based on monitoring of apnea
and snoring events.
Auto Off
When this feature is enabled, the device automatically discontinues therapy whenever the mask
is removed.
Auto On
With this feature, the device automatically initiates therapy when you breathe into the mask.
This feature is always enabled.
CPAP
Continuous Positive Airway Pressure.
iCode
A feature that is intended to give access to compliance and therapy management information.
The “iCode” consists of six separate codes displayed in the Patient Menu, each code is a
sequence of numbers. The “iCode QR” and “iCode QR+” display two-dimensional codes.
LPM
Liters Per Minute.
OSA
Obstructive Sleep Apnea.
Patient Menu
The display mode in which you can change patient-adjustable device settings, such as the
starting pressure for the Ramp feature.
Ramp
A feature that may increase patient comfort when therapy is started. It can reduce pressure
and then gradually increase the pressure to the prescription setting so the patient can fall
asleep more comfortably.
Reslex
A therapy feature that is enabled by your home care provider to provide pressure relief during
exhalation.
Standby State
The state of the device when power is applied but the airflow is turned off.

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min
Means the time unit “minute”.
h
Means the time unit “hour”.
yy mm dd / mm dd yy / dd mm yy
Means the date.
8. Model
Model
Product Description
Product
Contents
Optional
Accessory 1
Optional
Accessory 2
Work
Mode
Maximum
Work
Pressure
(hPa)
E-20A-H-O
Main device
(3.5-inch LCD)
Heated
Humidifier
SpO2 Kit
CPAP,
Auto
20
E-20AJ-H-O
Main device
(2.4-inch LCD)