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LIFE2000 VENTILATION SYSTEM INTRODUCTION
SAFETY INFORMATION
Please read the following safety warnings and cautions in their entirety before using the Breathe Technologies®
Life2000® Ventilation System. Warnings and cautions can also be found throughout this
Instructions for Use
.
WARNING:
• The Breathe Technologies® Life2000® Ventilation System is a restricted medical device intended for use
by qualified, trained personnel under the direction of a physician.
• Use the Breathe Technologies® Life2000® Ventilation System only for patients who meet the Indications
for Use. If the ventilation system is used for patients that do not meet the Indications for Use, patients may
not receive appropriate respiratory therapy.
• If the Breathe Technologies® Life2000® Ventilation System is not functioning properly, respiratory therapy
may be compromised and may result in patient harm or death. Always have an alternate means of
ventilation or oxygen therapy available.
• The operator of the ventilation system is responsible for reading and understanding this manual before
use.
• Failure to read this
Instructions for Use
may result in product misuse, which may cause equipment damage
or patient mistreatment.
• The prescription and ventilation settings should only be changed on the order of the supervising physician.
• When the ventilation system is in use, keep it in a well-ventilated area to prevent it from overheating.
The ventilation system may overheat and be permanently damaged if it is used in an area that is not well
ventilated.
• Do not allow smoking near oxygen sources or near the ventilation system and do not place oxygen
sources or the ventilation system near any source of direct heat or open flame because flammable
materials burn more readily in the presence of oxygen.
• Do not submerge the ventilation system in liquids or pour liquids on it. Liquids may cause components in
the system to malfunction.
• Do not use the Breathe Technologies® Life2000® Ventilation System in magnetic resonance imaging (MRI)
environments. MRI equipment may cause electronic components in the system to malfunction. Use of the
ventilation system in an MRI environment may damage the ventilation system or other equipment and may
cause severe injury.
• Do not use the ventilator or compressor in the presence of flammable anesthetics.
• Do not use the ventilation system with oxygen in the presence of flammable anesthetics such as fluroxene,
cyclopropane, divinyl ether, ethyl chloride, ethyl ether, and ethylene, as they may form flammable or
explosive mixtures with oxygen.
• Do not use the ventilator with helium or helium mixtures.
• Do not use the ventilator with nitric oxide.
• Do not use the ventilator in a hyperbaric chamber.
• Do not eat, drink, or chew gum while using the ventilation system. Food or liquids that make contact with
the ventilation system may cause components in the system to malfunction. Eating, drinking, or chewing
gum while using the system may also increase the risk of choking.
• Do not power on or use the compressor without the filters and condensation tray properly installed.
• Do not insert foreign objects into any part of the ventilation system.
• The backside of the ventilator enclosure may reach 49°C in a 40°C environment.
• Unauthorized modifications can result in equipment damage, or patient injury or death.
