2
1.3 Warnings and Cautions
Warnings
A warning indicates the possibility of injury to the user or operator.
Patient Monitoring Prior to placing a patient on the device, a clinical assessment should be performed to determine:
• The device alarm settings
• Needed alternative therapy equipment
• If an alternative monitor (alarming pulse oximeter or respiratory monitor) should be used
Personnel
Qualications
OmniLab Advanced + is a restricted medical device designed for use by trained and qualied personnel.
This manual serves as a reference.The instructions in this manual are not intended to supersede
the health care professional’s instructions regarding the use of the device.
The operator should read and understand this entire manual before using the device.
Battery Back-up
Power
The device has a two-stage low battery alarm. The medium priority alarm indicates that
approximately 20 minutes of operation remain, and the high priority alarm indicates that less
than 10 minutes of operation remain. Actual run time may be more or less than this and varies
with battery age, environmental conditions, and therapy.
Immediately seek an alternate power source when the “Low Battery” alarm appears.
Operating and
Storage Temperatures
Do not use this device if the room temperature is warmer than 40˚ C (104˚ F) because the
temperature of the airow may exceed 43˚ C (109˚ F).This could cause thermal irritation or
injury to the patient’s airway.
Do not use the device while positioned in a warm place, such as direct sunlight.
Device Start-Up Make sure the device is working properly at start-up (when entering standby mode). Always
verify that the audible tone sounds and the alarm LEDs light red then yellow momentarily.
Contact Philips Respironics or an authorized service center for service if these indications do
not occur at start-up. See Sections 3 and 4 for more information about device start-up.
Bacteria Filter Philips Respironics recommends that a main line outlet bacteria lter be used whenever the
device is used on multiple patients.
Therapy Modes/
Features
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.
Patient Circuits The device should only be used with patient interfaces (ex. masks, circuits and exhalation ports)
recommended by Philips Respironics. Proper operation of the device, including alarms, with
other circuits has not been veried by Philips Respironics and is the responsibility of the health
care professional or respiratory therapist.
An exhalation port is required. Do not block the exhalation port. This can reduce airow and
result in rebreathing of exhaled air.
At low expiratory pressures, the ow through the exhalation port may be inadequate to clear
all exhaled gas from the tubing – some rebreathing may occur.
When using a patient circuit with a full face mask, the mask must be equipped with a safety
(entrainment) valve. Make sure that the safety (entrainment) valve is functioning properly with
the device.
Improperly
Functioning Device
If you notice any unexplained changes in the performance of the device, if it is making unusual
sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if
the enclosure is cracked or broken, discontinue use and contact Philips Respironics or an
authorized service center for service.
Circuit Disconnect You should not rely on any single alarm to detect a circuit disconnect condition.The Low Minute
Ventilation and Apnea alarms should be used in conjunction with the Circuit Disconnect alarm.
Test the operation of the circuit disconnect function whenever a change is made to the circuit.
An increase in circuit resistance can prevent proper operation of some alarms.
