Evaluation: Xiaoniu AS100A Continuous Positive Airway Pressure (CPAP) Unit
December 30, 2019 | Evaluations & Guidance
- The AS100A is used to provide noninvasive positive airway pressure breathing therapy for the treatment of OSA in spontaneously breathing adult patients. It must be used with a CPAP mask (full face mask, nasal mask, or nasal pillow). The mask and tubing can be either purchased together with the device or purchased separately. It is not a life-support device and does not provide continuous breathing support.
- Major components and software features:
- Main unit
- Size: 24.7 × 14.8 × 9.9 cm (9.7 × 5.8 × 3.9 in)
- Weight: Approximately 1.26 kg (2.78 lb)
- Multilingual selection available: Chinese, English, Polish, Russian, and Spanish
- Integrated heated humidifier with removable water reservoir. It can be switched off; adjustable from level 1 to 5.
- Therapeutic pressure range: 4 to 20 cm H2O. Adjustable in the clinician's interface only.
- Two modes available, which can be changed in the clinician's interface only:
- CPAP: Clinician sets a therapeutic pressure between 4 and 20 cm H2O, which the device maintains throughout the night.
- Automatic positive airway pressure (APAP): The clinician sets both a minimum pressure above 4 cm H2O and a maximum pressure below 20 cm H2O. The device will adjust the therapeutic pressure between these settings throughout the night in response to the frequency of apnea episodes. We did not test the APAP algorithm as part of this Evaluation.
- Comfort features:
- Pressure ramp (Start Pressure): Start Pressure starts at the selected low pressure and slowly increases to the therapeutic pressure (Treat Pressure) over a short period of time. i) Start Pressure is adjustable from 4 to 20 cm H2O. ii) Ramp time is adjustable from 0 to 60 min, in five-minute increments.
- AS-Elex expiration pressure relief: AS-Elex reduces the pressure during exhalation by a few cm H2O. It can be switched off and is adjustable from 1 to 7.
- Mask wear: Allows patient to check for leaks around the mask.
- Memory: Up to five years of data on the 16 GB SD card.
- 3.5-inch color LCD, touchscreen display
- Accessories and consumables
- Flexible plastic nonheated tubing to connect device to mask: Length of 1.8 m (5.9 ft) with internal diameter of 19 mm (0.75 in)
- Air filter must be replaced every three months.
- Mask: Patient can select type of mask depending on preference: Nasal mask, full face mask, or nasal pillow. Note: While the device must be used with a CPAP mask, the mask can either be purchased with the device or purchased separately. Any CPAP mask with a passive exhalation port can be used with this unit. Noninvasive ventilation (NIV) masks do not have a passive exhalation port and can only be used with ventilators that have an active exhalation valve. Using an NIV mask with this or any CPAP unit will result in rebreathing a potentially dangerous amount of CO2.
- Carry bag
- User manual
- NeoRead software that can be downloaded to a clinician's computer to allow the clinician to read data from the patient's SD card or device and display therapy data.
- NeoAiP mobile apps that can be downloaded to the patient's Android phone to allow the patient to adjust therapy parameters and generate a report. The report can then be sent to the clinician via e-mail or a messaging platform such as WhatsApp or WeChat. This mobile app is currently available in China only.
- Main unit
- The AS100A is primarily used in the patient's home but can...