SECTION 1
SERHT50NA A0808 1-1
OPERATOR’S RESPONSIBILITY FOR PATIENT SAFETY
The Operation manual (p/n OPRHT50-NA) contains information
intended to ensure safe and effective ventilator use. The label on
the inside of the front panel cover door is meant to complement not
replace the Operation manual.
The design of the HT50 ventilator, the Operating and Service
manuals, and the labeling on the ventilator take into consideration
that the purchase and use of the equipment is restricted to trained
professionals, and that certain inherent characteristics of the
ventilator are known to the operator. Instructions, warnings and
caution statements are therefore limited to the specifics of the
Newport HT50.
Caution Federal law restricts this device to sale by or on the
order of a physician.
This man
ual excludes references to various hazards which are
obvious to medical professionals and operators of this equipment,
to the consequences of product misuse, and to potentially adverse
effects in patients with abnormal conditions.
When the HT50 is used in home care and sub acute environments it
is important that the primary caregiver has received training and has
demonstrated competency in all equipment functions. A specific
written care plan must be established by the attending physician.
Transport of patients with the HT50 requires that medical staff have
a good working knowledge of the ventilator’s use and problem
resolution. Proper emergency back-up equipment must be
immediately available during transport.
HT50 operators must recognize their responsibility for implementing
safety monitoring mechanisms which supply appropriate
information on equipment performance and patient condition.
Patient safety may be achieved through a wide variety of means
such as electronic surveillance of equipment performance and
patient condition. However, equipment surveillance should not
replace direct observation of clinical signs. The HT50 operator is
solely responsible for selecting the appropriate level and method of
patient monitoring.
Product modification or misuse can be dangerous. Newport Medical
Instruments, Inc. (N
EWPORT) disclaims all liability for the
consequences of product alterations or modifications, as well as for
the consequences which might result from the combination of this
ventilator with other products, whether supplied by Newport or by
other manufacturers, unless such a combination has been
specifically endorsed by Newport.
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