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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.
INSTALLATION
These instructions describe how to connect a Dual Limb Patient Circuit to the
iVent
you connect the Exhalation Valve and its accessories to the ventilator, second
you connect the tubing.
NOTE
CAUTION
Reusable Barb/Luer Fitting
Reusable VersaMed's Y and Flow
Sensor
Reusable One-way Valve
Cap Red
Sleeve Cap
PEEP pressure line
This device contains Phthalates
201 ventilator. Connecting the Patient Circuit is a two step process: first
TM
Note: The instructions provided below only refer to devices in which the
Transport Mounting plate (PN M1169908) is installed. For additional
information regarding Transport Mounting plate installation, refer to your local
customer support
Insert the Exhalation valve and the Patient Circuit as shown in these instructions.
The Exhalation Valve should be cleaned or sterilized once a month. Follow the
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Appendix G: Accessories
M1161821
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