GE iVent 201 Series, User'S Reference Manual

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Appendix G: Accessories
243
DISPOSABLE BREATHING CIRCUIT
These instructions refer to the following breathing circuits:
Breathing Circuit REF
Breathing Circuit 1.8M M1162026/ 620B0020-A0
Breathing Circuit 3.85M M1173406/ 620B0035-01
Breathing Circuit with heated wire M1162013/ 620B0022-A0
WARNING U.S. Federal law restricts the sale of this device and its use by, or on the
order, of a physician.
The patient circuit shall be replaced before new patient connection.
Single use circuit, shall not be used longer than 30 days.
This single-use product is not designed or validated to be reused. Reuse
may cause a risk of cross-contamination, affect the measurement
accuracy, system performance, or cause a malfunction as a result of the
product being physically damaged due to cleaning, disinfection, re-
sterilization, or reuse.
CAUTION Single patient use only. Not intended for sterilization.
This circuit is intended for use only by properly trained medical personnel.
This device contains Phthalates
Risks and Precautionary Measures related to Phthalates:
This instruction pertains to the phthalate symbol marked on the device or its
packaging. If this device is used for the treatment of children, or treatment of
pregnant or nursing women; please note that the following types of procedures
may increase the risk of exposure to phthalates: Exchange transfusion in
neonates, total parenteral nutrition in neonates, multiple procedures in sick
neonates, haemodialysis in prepuberal males, male foetus and male infant of
pregnant women, and lactating women; and massive blood infusion into trauma
patients. Although these procedures have the potential for increased risk of
exposure, conclusive evidence of human health risks has not been established. As
a precautionary measure, to reduce the potential for unnecessary exposures to
phthalates, the product must be used in accordance with the instructions for use,
and practitioners should refrain from using this product beyond the period of
time the product is medically necessary or needed.
Single patient use only, not intended for sterilization.
This circuit is intended for use only by properly trained medical personnel.