Flight Medical Innovations 60 Series Service Manual page 4

Legal Notice
Legal Notice
Disclaimer
FLIGHT MEDICAL INNOVATIONS Ltd. (FLIGHT MEDICAL) provides this Service Manual
in its commitment to help reduce patient risk and injury. However, this manual is not
intended to in any way replace or substitute duty of care to a patient, professional
responsibility, or professional judgment, nor is it intended to provide any warranty,
promise, guarantee, assumption of risk or duty, release, or indemnity. Physicians
shall at all times maintain responsibility for patient treatment and outcomes, and
FLIGHT MEDICAL further assumes no liability for patient treatment or outcome or for
physician's negligence, breach of duty of care, or malpractice.
The FLIGHT 60 Ventilator operator is solely responsible for selecting the appropriate
level and method of patient monitoring.
Product modification or misuse can be dangerous. FLIGHT MEDICAL 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 FLIGHT MEDICAL or by other manufacturers, unless
such a combination has been specifically endorsed by FLIGHT MEDICAL.
The design of FLIGHT 60 Ventilator, the Operator's 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 FLIGHT 60
Ventilator.
Federal law (US) restricts this device to sale by or on the order of a physician.
This Operator's Manual excludes references to various hazards which are obvious to
medical professionals and operators of this equipment, to the consequences of
product misuse, and to potential adverse effects in patients with abnormal conditions.
When the FLIGHT 60 Ventilator is used in homecare and subacute environments, only
properly trained personnel should operate the ventilator. The FLIGHT 60 Ventilator is
a restricted medical device designed for use by respiratory therapists or other
properly trained and qualified personnel under the direction of a physician and in
accordance with applicable state laws and regulations.
Transport of patients with the FLIGHT 60 Ventilator requires that medical staff have a
good working knowledge of the ventilator's use and problem resolution. Proper
emergency backup equipment must be immediately available during transport.
FLIGHT 60 Ventilator 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
ii | FLIGHT 60 Service Manual