Dräger VentStar heated Instrucciones De Uso página 4

English / English US
kInstructions for use VentStar heated and VentStar dual heated en
VentStar heated and VentStar dual heated
Disposable breathing circuit
Trademarks
®
– VentStar
®
– Infinity
®
– Evita 4
®
– Evita XL
are trademarks owned by Dräger.
Safety information definitions
WARNING
A WARNING statement provides important information about a
potentially hazardous situation which, if not avoided, could result
in death or serious injury.
CAUTION
A CAUTION statement provides important information about a
potentially hazardous situation which, if not avoided, may result in
minor or moderate injury to the user or patient or in damage to the
medical device or other property.
NOTE
A NOTE provides additional information intended to avoid
inconvenience during operation.
Definition of the target group
For this medical device users are defined as target group. This target
group has been instructed in the use of the medical device and has the
necessary expertise, training, and knowledge to use or install the medical
device. Dräger emphasizes that the medical device must be used or
installed exclusively by the defined target group.
Users
Users are persons who may use the medical device in accordance with
its intended use.
For your safety and that of your patients
WARNING
Risk of incorrect operation and of misuse
Any use of the medical device requires full understanding and
strict observation of all sections of these instructions for use.
The medical device must only be used for the purpose specified
under Intended use. Strictly observe all WARNING and CAUTION
statements throughout these instructions for use and all
statements on medical device labels.
Failure to observe these safety information statements
constitutes a use of the medical device that is inconsistent with
its intended use.
WARNING
To avoid contamination and soiling, keep the medical device
packaged until ready to be used. Do not use the medical device if
the packaging is damaged.
WARNING
Installation to the basic device must be in accordance with the
instructions for use of the basic device on which this medical
device is used.
Make sure that the connection to the basic device system is
secure.
WARNING
Do not modify the medical device. Modification may damage or
impair the proper functioning of the device which may lead to
patient injury.
WARNING
Risk of malfunction
Obstructions, damage, and foreign matter can lead to
malfunction.
Check all system components for obstructions, damage, and
foreign matter before installation.
CAUTION
The medical devices are not available individually. Only one copy of
the instructions for use is included in the clinical package and must
therefore be kept in a location accessible for users.
Intended use
Disposable inspiratory heated breathing circuit with humidifier chamber
for connection to a Fisher & Paykel MR850 humidifier, for conveying
moistened breathing gas between the humidifier and adult patients with
a body weight of more than 40 kg (88 lbs).
The medical device is tested for system compatibility and released for
use with specific basic devices, e.g., Evita Infinity V500.
For further information on system compatibilities, see the lists of
accessories of the basic devices or other documents issued by Dräger.
4
English / English US
Overview
D
E
F
D
E
F
C
A Device-side connectors
B Connection hose to the humidifier chamber
C Water trap (only included with MP00307)
D Heated inspiratory hose
E Y-piece
F Expiratory hose (only heated with MP00306)
G Humidifier chamber
H Patient-side temperature sensor (see "Installation and operation")
I Humidifier-side temperature sensor (see "Installation and operation")
J Supply container (see "Installation and operation")
Symbols
Not made with
Keep away from sunlight
LATEX
natural rubber latex
Consult instructions for
Caution
use
Storage temperature
Do not reuse
limitation
Do not use if package is
Do not open with knife
damaged
Atmospheric pressure Relative humidity
Do not use with oil and
Use by
grease
Date of manufacture Non-sterile
NON
STERILE
REF
Manufacturer Part number
LOT
Quantity Lot number
Installation and operation
A
F
F
B
E
H
C
D
I
G
The disposable breathing circuit must be installed according to the
illustration.
WARNING
Confirm that all connections are secure and free of leakages.
Perform a selftest of the basic device including a leakage test
after the breathing circuit (hose, filter/HME, etc.) has been
completely installed and before use on the patient.
WARNING
Risk of patient injury
During installation position the breathing circuit so that the risk
of tripping or of stepping on the breathing circuit is minimized.
WARNING
Risk of patient injury
B A
Make sure to install the breathing circuit without loops and kinks
as they may increase resistance.
WARNING
Risk of fire
G
The heated breathing circuit must never be operated without gas
flow. The humidifier must be switched off if the gas flow is
MP00306
interrupted.
WARNING
Risk of patient injury
If too much condensate accumulates, a partial or complete
B A
blockage of the breathing circuit can occur.
Regularly check the breathing circuit for condensate and empty
if necessary.
WARNING
G
Risk of patient injury
Adding further components and using incompatible components
may increase inspiratory and expiratory resistance and adversely
affect the performance of the ventilator.
F
WARNING
MP00307
Risk of patient injury
Wrong installation can lead to malfunction of the water trap.
Install the water trap correctly.
WARNING
Risk of patient injury
If the water trap is installed higher than the patient, condensate
can flow into the breathing hoses.
Install the water trap at the lowest point of the breathing circuit
and below patient level.
WARNING
Risk of patient injury
If the water trap is not emptied regularly, condensate can
accumulate in the breathing circuit. A partial or complete
blockage of the breathing circuit can occur.
Regularly check the water trap for condensate and empty if
necessary.
WARNING
Risk of contamination
The content of the water trap can be contaminated.
Dispose of the content of the water trap according to the hospital
regulations. Proceed with caution when handling the water trap.
WARNING
Risk of patient injury
When the water trap container is disconnected from the water
trap, there is a higher risk of leakage. During a leakage PEEP can
fall and VT might not be reached.
After emptying reinstall and close the water trap container as
quickly as possible.
WARNING
Risk of malfunction
If the water trap does not hang vertically, malfunction can occur.
Install the water trap vertically.
WARNING
Risk of patient injury
The humidifier chamber must be positioned lower than the
patient.
J
WARNING
Risk of increased gas temperature
The temperature sensors (H) and (I) must be securely fitted to the
breathing circuit.
Failure to ensure that the temperature sensors are correctly fitted
will mean that the device is unable to regulate the temperature.
WARNING
When using active humidification, do not use the breathing
circuit in conjunction with a heat and moisture exchanger (HME).
There is a risk of pressure buildup and of insufficient ventilation
as a result of water accumulating in the HME.
WARNING
Only use filters on the device side (ventilator) and monitor
pressure buildup.
WARNING
Fill the humidifier chamber with distilled water before using the
breathing circuit and check the function of the floater.
WARNING
Risk of burns
Avoid prolonged and direct contact between the breathing circuit
and the patient's skin.
WARNING
Risk of burns
The heated breathing circuit must not be covered with bed sheets,
hand towels or similar flammable objects.
Instructions for use VentStar heated and VentStar dual heated