Infinity Id Breathing Circuit Heated (N) - Dräger Infinity ID Instrucciones De Uso

English/English US
Instructions for use Infinity ID Breathing Circuit heated (N) en/enUS

Infinity ID Breathing Circuit heated (N)

Trademarks
Trademarks owned by Dräger
Trademark
®
Infinity
®
Evita
®
Babylog
The following web page provides a list of the countries in which the trade-
marks are registered: www.draeger.com/trademarks
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.
WARNING
Risk of patient injury
Nebulize only water-based drugs.
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 for connection to a Fisher
& Paykel MR850 humidifier, for conveying moistened breathing gas
between the humidifier and neonatal patients with a body weight of up to
5 kg (11 lbs). Intended for single-use only.
Breathing circuit with integrated transponder. The transponder serves as
a carrier of product-specific data for processing by Dräger Infinity ID
equipment.
The medical device is tested for system compatibility and released for
use with specific basic devices, e.g., Babylog VN500.
For further information on system compatibilities, see the lists of
accessories of the basic devices or other documents issued by Dräger.
WARNING
Patient parameters, the patient's clinical status, and the
properties of components of the breathing circuit (e.g., tube) may
influence or limit the performance characteristics of the
breathing circuit during high-frequency ventilation. Ensure
appropriate patient monitoring (e.g., by means of blood gas
analysis).
NOTE
The transponder is located under the device connector with the
"Infinity ID" designation and must not be damaged or removed.
Otherwise the correct Infinity ID functionality can be compromised.
4
English/English US
NOTE
After using Infinity ID breathing circuits for the first time, Infinity ID
functionality is available for a period of 21 days.
Only use and/or combine accessories with the Infinity ID designation.
Otherwise the correct Infinity ID functionality can be compromised.
NOTE
Product-specific data are saved on the transponder. Use the breathing
circuit only with components contained in the set. Otherwise the correct
Infinity ID functionality can be compromised.
NOTE
The Infinity ID functionality is only available when using Infinity ID main
devices.
Overview
F D
E E
G
E H
C
A Device-side connectors
B Connection hose to the humidifier chamber
C Water trap
D Heated inspiratory hose
E Connectors for connecting accessories
F Hose extension for use in the incubator
G Y-piece
H Unheated expiratory hose
I Humidifier chamber
J Temperature sensors (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
Ambient 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
(N) Neonatal
For USA: Caution: Federal law restricts this device to sale by or on the
Rx only order of a physician.
Installation and operation
E H H
G
C
E
J
F
E
D
J
The disposable breathing circuit must be installed according to the
illustration.
The hose extension (F) can be dismantled to enable the breathing circuit
to be used outside of the incubator.
CAUTION
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
Make sure to install the breathing circuit without loops and kinks
as they may increase resistance.
CAUTION
Risk of burns
The heated breathing circuit must never be operated without gas flow.
The humidifier must be switched off if the gas flow is interrupted.
CAUTION
Risk of patient injury
B A
If too much condensate accumulates, a partial or complete blockage of
the breathing circuit can occur.
Regularly check the breathing circuit for condensate and empty if
necessary.
I
WARNING
Risk of patient injury
A
Adding further components and using incompatible components
may increase inspiratory and expiratory resistance and adversely
H
affect the performance of the ventilator.
MP00343
CAUTION
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.
CAUTION
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.
WARNING
Risk of increased gas temperature
The temperature sensors (J) must be securely fitted to the
breathing circuit.
A
Failure to ensure that the temperature sensor is correctly fitted
will mean that the device is unable to regulate the temperature.
B
CAUTION
Risk of reduced humidification
When used in conjunction with the operation of incubators and warming
therapy units, the temperature sensor must be mounted outside of the
heat source.
I
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.
CAUTION
Risk of burns
Avoid prolonged and direct contact between the breathing circuit and
the patient's skin.
Instructions for use Infinity ID Breathing Circuit heated (N)