Ece Medical Respirox T-30T plus User manual

Respirox®BPAP System
T-30T plus
User Manual
0123

BPAP System T-30T plus User Manual V2.11
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····················································································· 6
7. Glossary ·································································································· 7
8. Model ····································································································· 8
9. Package Contents······················································································· 9
10. System Features······················································································10
11. First Time Setup······················································································11
11.1 Placing the Device··········································································11
11.2 Installing the Air Filter and Filter Cap···················································12
11.3 Connecting to Power·······································································12
11.4 Assembling the Tube and Mask ··························································13
11.5 Using Oxygen with the Device ···························································14
11.6 Inserting the SD Card (Only for the device that equipped with SD card)········14
11.7 Using the SpO2Kit··········································································15
11.7.1 Connecting the SpO2Kit to the Main Device ································16
11.7.2 Removing the SpO2Kit from the Main Device·······························16
11.8 Using the H60 Heated Humidifier ·······················································18
11.9 Starting Treatment ·········································································18
12. Routine Use ···························································································18
12.1 Connecting the Tube·······································································18
12.2 Adjusting the Tube ·········································································19
12.3 Turning on the Airflow ·····································································19
12.4 Heating the Water in the Humidifier ····················································19
12.5 Using the Ramp Button····································································19
12.6 Turning the Device Off·····································································19
13. Navigating the Patient Menu·······································································20
13.1 Steps to Navigating the Patient Menu ··················································20
13.1.1 Accessing the Main Interface ··················································20
13.1.2 Bringing up the Initial Setup Interface ·······································20
13.1.3 Accessing the Setup Interface ·················································20
13.1.4 Selecting Options·································································21
13.1.5 Adjusting Options ································································21
13.1.6 Confirming Adjustments ························································21
13.1.7 Turning Pages·····································································22
13.1.8 Exiting the Patient Menu························································22
13.2 Options of the Patient Menu and Corresponding Descriptions ·····················24
14. Alert ····································································································25
15. Cleaning and Disinfection···········································································27
15.1 Cleaning the Mask and Headgear ·······················································27
15.2 Cleaning the SpO2Kit······································································27
15.3 Cleaning the Water Chamber of the Humidifier·······································27
15.4 Cleaning the Enclosure ····································································27
15.5 Cleaning the Tube ··········································································27
15.6 Replacing the Air Filter ····································································28
15.7 Disinfection ··················································································28
16. Traveling with the Device···········································································29

BPAP System T-30T plus User Manual V2.11
17. Transferring the Device to Another Patient······················································29
18. Reordering·····························································································30
19. Technical Support ····················································································30
20. Disposal································································································30
21. Troubleshooting ······················································································31
21.1 Common Problems in Patients and Corresponding Solutions·······················31
21.2 Common Problems in the Device and Corresponding Solutions ···················33
22. EMC Requirements···················································································34
23. Limited Warranty·····················································································39

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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 (15ºtilted)
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
Respirox®BPAP System is a Bi-level Positive Airway Pressure device, which is intended to
provide non-invasive ventilation for patients with obstructive sleep apnea (OSA), 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.
CAUTIONS!
• This device is restricted to sale by or on the order of a physician.
• The device is intended for use by operators trained or experienced in similar equipment.
• The patient is an intended operator.
•Cleaning and disinfection can be performed by the patient.