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Trilogy200 clinical manual
4
Personnel
Qualications
Trilogy200 is a restricted medical device designed for use by
Respiratory Therapists or other trained and qualied caregivers under
the supervision of a physician.
The prescription and other device settings should only be changed on
the order of the supervising physician.
The operator of the ventilator is responsible to read and understand
this manual before use.
Modes of
Ventilation
The device can provide therapies typically associated with both
ventilator dependent and non-dependent patients. The mode of
ventilation, circuit type, and alarm strategies should be chosen after a
clinical evaluation of each patient’s needs.
C-Flex, Bi-Flex, and AVAPS are intended for use by adult patients.
SD Card
Prescription
Changes
When you change the device prescription, alarms, and other settings
using the SD card, Trilogy200 requires that the caregiver review and
verify the changes prior to the changes being used by the device. The
caregiver or health care professional is responsible to ensure that the
prescription settings are correct and compatible with the patient after
using this feature. Installing the wrong prescription for a particular
patient may result in improper therapy, lack of appropriate safety
monitoring, and risk of death or injury to the patient.
Electrical
Interference
This device is intended for use in the electromagnetic environment
specied in Chapter 13 of this manual. The user of this device should
make sure it is used in a compatible environment.
Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than the
recommended separation distance calculated using the information
provided in Chapter 13 of this manual.
Battery Back-up
Power
The internal battery is NOT intended to serve as a primary power
source. It should only be used when other sources are not available or
briey when necessary; for example, when changing power sources.
The ventilator 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. Complete power failure and loss of therapy is imminent.