Dräger Infinity ID Gebrauchsanweisung Seite 4

English / English US
Instruction for use Infinity ID Breathing Circuit Watertrap (N) 180 en / enUS
Infinity ID Breathing Circuit Watertrap (N) 180
Trademarks
®
– Infinity
is a trademark owned by Dräger.
Safety information definitions
WARNING
A WARNING statement provides important information about a po-
tentially hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important information about a potenti-
ally hazardous situation which, if not avoided, may result in minor or
moderate injury to the user or patient or in damage to the medical de-
vice or other property.
NOTE
A NOTE provides additional information intended to avoid inconveni-
ence 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 in-
stalled 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 state-
ments on medical device labels.
Failure to observe these safety information statements consti-
tutes a use of the medical device that is inconsistent with its in-
tended 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 in-
structions for use of the basic device on which this medical de-
vice 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 pa-
tient injury.
CAUTION
The medical devices are not available individually. Only one copy of the
instructions for use is included in the clinical package and must there-
fore be kept in a location accessible for users.
CAUTION
Risk of malfunction
Obstructions, damage, and foreign matter can lead to malfunction.
Check all system components for obstructions, damage, and foreign
matter before installation.
Intended use
Breathing circuit for conduction of respiratory gases between anesthesia
machine or ventilator and neonate. Intended for single-use only. Water
traps are intended for collection of condensate.
The breathing circuit is a standard breathing circuit with a water trap in
each breathing hose limb.
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., Evita Infinity V500.
For further information on system compatibilities, see the lists of acces-
sories of the basic devices or other documents issued by Dräger.
CAUTION
The transponder is located under the device connector with the
"Infinity ID" designation and must not be damaged or removed or the
Infinity ID function may be impaired.
CAUTION
After using Infinity ID breathing circuits for the first time, Infinity ID func-
tionality 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
The circuit diameter of 10 mm is specially designed for neonatal pa-
tients. Neonatal – pertaining to an individual weighing less than 5 kg
(11 lbs).
Overview
B
A
C
4
A Device-side connectors
B Breathing hoses (inspiratory and expiratory)
C Water traps
D Y-piece with Luer-Lock
Symbols
Not made with natural rub-
LATEX
ber latex
Caution
Do not reuse
Do not use if package is
damaged
Atmospheric pressure
Use by
Date of manufacture
Manufacturer
Quantity
Output
For USA: Caution: Federal law restricts this device to sale by or on the
Rx only order of a physician.
Installation and operation
WARNING
Confirm that all connections are secure and free of leakages.
Perform a selftest of the basic device including a leakage test af-
ter the breathing circuit (hose, filter/HME, etc.) has been com-
pletely 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.
WARNING
Risk of patient injury
If too much condensate accumulates, a partial or complete block-
age of the breathing circuit can occur.
Regularly check the breathing circuit for condensate and empty
if necessary.
WARNING
Risk of patient injury
Adding further components and using incompatible components
may increase inspiratory and expiratory resistance and adversely
affect the performance of the basic device.
WARNING
Risk of fire
In combination with oxygen or nitrous oxide, ignition sources
such as electrosurgery and laser surgery devices can cause
fires. To protect patient and users, prevent leakages from hoses
carrying oxygen or nitrous oxide.
Before beginning electrosurgery or laser surgery, flush the vicin-
ity of gas-carrying parts (endotracheal tube, mask, Y-piece, hos-
es, filter, and breathing bag) sufficiently with air (<25 % O2); flush
beneath the surgical drapes as well.
WARNING
Risk of fire
In order not to damage the breathing circuit, keep a distance of at
least 200 mm (7.9 in) between hoses carrying oxygen or nitrous
oxide and a possible ignition source (e.g., electrosurgery or laser
surgery devices).
WARNING
Risk of patient injury
A Luer Lock connector must only be used for gas monitoring.
Any other use of the Luer Lock connector may endanger the pa-
tient.
NOTE
When not in use, the Luer Lock connector must be sealed with its cap.
WARNING
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 too high in the breathing circuit, con-
densate can flow into the breathing hoses.
B
Install the water trap at the lowest point of the breathing circuit
D
and below patient level.
MP01328
English / English US
WARNING
Risk of patient injury
If the water trap is not emptied regularly, condensate can accu-
mulate 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 ne-
cessary.
Keep away from sunlight
WARNING
Consult instructions for
Risk of contamination
use
The content of the water trap can be contaminated.
Storage temperature
Dispose of the content of the water trap according to the hospital
limitation
regulations. Proceed with caution when handling the water trap.
Do not open with knife
WARNING
Risk of patient injury
Relative humidity
When the water trap container is disconnected from the water
trap, there is a higher risk of leakage.
Do not use with oil and
During a leakage PEEP can fall and VT might not be reached.
grease
After emptying reinstall and close the water trap container as
Non-sterile
quickly as possible.
NON
STERILE
REF Part number WARNING
Risk of malfunction
LOT Lot number
If the water trap does not hang vertically, malfunction can occur.
Install the water trap vertically.
The breathing circuit can be used with the following gases and anesthetic
agents: Nitrous oxide, sevoflurane, desflurane, isoflurane, halothane, en-
flurane.
Cleaning and disposal
The user is responsible for regularly replacing the medical device accord-
ing to the hygiene regulations.
WARNING
Reuse, reprocessing, or sterilization can lead to failure of the
medical device and cause injury to the patient.
This medical device has been designed, tested, and manufac-
tured exclusively for disposable use. The medical device must
not be reused, reprocessed, or sterilized.
WARNING
Following use, the medical device must be disposed of according
to local public health and waste disposal regulations in order to
avoid possible contamination.
Technical data
Breathing hose length
Breathing circuit volume
Material
Breathing hoses
Connectors
Y-piece
Watertraps
Performance data
Breathing circuit
Insp./exp. resistance at 60 L/min
Insp./exp. resistance at 30 L/min
Insp./exp. resistance at 15 L/min
Insp./exp. resistance at 5 L/min
Insp./exp. resistance at 2.5 L/min
Compliance at 30 mbar and
60 mbar
Leakage at 60 mbar
Ambient conditions
During storage
Temperature
Relative humidity
Atmospheric pressure
During operation
Temperature
Relative humidity
Atmospheric pressure
Classification
according to Directive 93/42/EEC
Annex IX
UMDNS code
Universal Medical Device Nomen-
clature System –
nomenclature for medical devices
Protection class
The medical device meets the requirements of the ISO 80601-2-13 stan-
dard.
1) 1 bar = 1 kPa x 100
Order list
Designation
Infinity ID Breathing Circuit Watertrap (N) 180
Additional items according to Dräger accessories cata-
log
1.80 m (70 in)
0.5 L
EVA
PP
PC/TPE
SAN, PP, POM, TPE
1)
<28.8 mbar (<29.4 cmH
<7.4 mbar (<7.6 cmH
<1.9 mbar (<1.9 cmH
<0.3 mbar (<0.3 cmH
<0.1 mbar (<0.1 cmH
<0.9 mL/mbar (<0.9 mL/cmH
<50 mL/min
–20 °C to 60 °C (–4 °F to 140 °F)
5 % to 95 % (non-condensing)
500 hPa to 1200 hPa (7.3 psi to
17.4 psi)
5 °C to 40 °C (41 °F to 104 °F)
5 % to 95 % (non-condensing)
500 to 1200 hPa (7.3 psi to 17.4 psi)
Class IIa
14-238
I, Type BF
Instruction for use Infinity ID Breathing Circuit Watertrap (N) 180
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Order No.
MP01328