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Section 1: Introduction
1.1 Package Contents
The OmniLab Advanced + system may include the following components. Some components are optional accessories
that may not be packaged with the device.
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OmniLab Advanced + device 6 Power cord retainer and screw
2 Humidier (optional) 7 AC power adapter
3 Clinical manual 8 Reusable gray foam lter
4 Flexible tubing (1.8 m x 22 mm) 9 Disposable white ultra-ne lter
5 Power cord 10 SD card (optional)
1.2 Intended Use
The OmniLab Advanced + is intended to provide non-invasive ventilation for pediatric patients 7 years or older
>18.2 kg (40 lbs) with Respiratory Insufciency or Obstructive Sleep Apnea (OSA). It is also intended to treat adult
patients >30 kg (66 lbs) with Respiratory Insufciency or Obstructive Sleep Apnea caused by central and/or mixed
apneas and periodic breathing. The device is intended for use in the hospital.
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex, C-Flex+ or AVAPS therapy features or the autoSV
mode has not been established for pediatric patients at this time.