Dräger Infinity ID Notice D'utilisation page 4

English/English US
Instructions for use Infinity ID Breathing Circuit Basic en /enUS
Trademarks
Trademarks owned by Dräger
Trademark
®
Infinity
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 poten-
tially 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 inconve-
nience during operation.
User group requirements
The term "user group" describes the personnel responsible who have
been assigned by the operating organization to perform a particular task
on a product.
Duties of the operating organization
The operating organization must ensure the following:
– Every user group has the required qualifications (e.g., has undergone
specialist training or acquired specialist knowledge through experi-
ence).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant chapters in
this document.
User groups
Clinical users
This user group operates the product in accordance with the intended
use.
Users have medical specialist knowledge in the application of the prod-
uct.
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 main device must be in accordance with the in-
structions for use of the main device on which this medical de-
vice is used.
Make sure that there is a safe connection to the main device.
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.
WARNING
Risk of malfunction
Obstructions, damage, and foreign matter can lead to malfunc-
tion.
Check all system components for obstructions, damage, and for-
eign 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.
CAUTION
When connecting or disconnecting breathing hoses, always grip the
sleeve, not the spiral reinforcement. Otherwise, the breathing hose
may be overstretched and damaged.
Mandatory reporting of adverse events
Serious adverse events with this product must be reported to Dräger and
the responsible authorities.
Intended use
Breathing circuit for conveying breathing gases between an anesthesia
machine or ventilator and a patient. Intended for single use only.
The Infinity ID breathing circuit is equipped with a transponder with
product-specific data for processing by Dräger Infinity ID equipment.
4
English/English US
CAUTION
The transponder is located under the device connector with the "Infinity
ID" designation and must not be damaged or removed. Otherwise the
Infinity ID function can be compromised.
CAUTION
After using Infinity ID breathing circuits for the first time, the Infinity ID
function is available for a period of 21 days.
Only use and/or combine accessories with the "Infinity ID" designation.
Otherwise the Infinity ID function can be compromised.
The medical device is tested for system compatibility and released for
use with specific main devices, e.g., Evita Infinity V500.
For further information on system compatibilities, see the lists of acces-
sories of the main devices or other documents issued by Dräger.
WARNING
Excessive resistance or compliance values may lead to insuffi-
cient ventilation and injury of the patient. Select a suitable breath-
ing circuit for the patient.
NOTE
The breathing circuit is designed for adults. The diameter of the bre-
athing hose is 22 mm (0.87 in). Adult - pertains to an individual
weighing more than 40 kg (88 lb).
Overview
A B
A Device-side connectors
B Breathing hoses (inspiratory hose and expiratory hose)
C Y-piece
D Elbow with Luer Lock connector
Symbols
Additional information about the symbols is available on the following
web page: www.draeger.com/md-symbols
Not made with natural rub-
Keep away from sunlight
LATEX
ber 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
The product is a medical
MD
Output device (CE conformity
assessment procedure)
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 tight.
Perform a selftest of the main device including a leakage test af-
ter the breathing circuit (hose, filter, etc.) has been completely in-
stalled 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 condensed water accumulates, a partial or complete
blockage of the breathing circuit can occur.
Regularly check the breathing circuit for condensed water and
empty if necessary.
WARNING
Risk of patient injury
Adding further components and using incompatible components
may increase inspiratory and expiratory resistance and adverse-
ly affect the performance of the ventilator.
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 carry-
ing 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 % O
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 patient.
NOTE
When not in use, the Luer Lock connector must be sealed with its cap.
C D
The breathing circuit can be used with the following gases and anesthetic
agents: Nitrous oxide, sevoflurane, desflurane, isoflurane, halothane, en-
flurane.
Period of use
The user is responsible for regularly replacing the medical device accord-
ing to the hospital's 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
manufactured exclusively for single use. The medical device
must not be reused, reprocessed, or sterilized.
NOTE
This medical device has been designed, tested, and manufactured for
single use and a maximum period of use of 7 days.
Disposal
CAUTION
Following use, the medical device must be disposed of according to lo-
cal public health and waste disposal regulations in order to avoid pos-
sible contamination.
Technical data
MP01348
Breathing hose length 2.5 m (98 in)
Volume of the breathing 1.9 L
circuit
Material
Breathing hoses PE
Connectors PP, EVA
Y-piece PP
Elbow/Luer Lock cap PP/TPE
Performance data
Breathing circuit
Insp./Exp. resistance
at 60 L/min <1.6 mbar
(<1.6 cmH
at 30 L/min <0.5 mbar
(<0.5 cmH
at 15 L/min <0.2 mbar
(<0.2 cmH
at 5 L/min <0.1 mbar
(<0.1 cmH
at 2.5 L/min <0.1 mbar
(<0.1 cmH
Compliance at 30 mbar <3.1 mL/mbar
(<3.1 mL/cmH
Compliance at 60 mbar <2.8 mL/mbar
(<2.8 mL/cmH
Leakage at 60 mbar <50 mL/min
Ambient conditions
During storage
Temperature –20 to 60 °C (–4 to 140 °F)
Relative humidity 5 % to 95 % (non-condensing)
Ambient pressure 500 to 1200 hPa (7.3 psi to 17.4 psi)
During operation
Temperature 5 to 40 °C (41 to 104 °F)
Relative humidity 5 % to 95 % (non-condensing)
Ambient pressure 500 to 1200 hPa (7.3 psi to 17.4 psi)
Classification Medical Class IIa
Device Europe
UMDNS code 14-238
Universal Medical Device
Nomenclature System –
nomenclature for medical
devices
Protection class Type BF
The medical device meets the requirements of the ISO 80601-2-13 stan-
dard.
1) 1 bar = 1 kPa x 100
Instructions for use Infinity ID Breathing Circuit Basic
); flush
2
MP01350
1.8 m (70 in)
1.4 L
PE
PP, EVA
PP
PP/TPE
1)
<1.4 mbar
O) (<1.4 cmH O)
2 2
<0.4 mbar
O) (<0.4 cmH O)
2 2
<0.1 mbar
O) (<0.1 cmH O)
2 2
<0.1 mbar
O) (<0.1 cmH O)
2 2
<0.1 mbar
O) (<0.1 cmH O)
2 2
<2.8 mL/mbar
O) (<2.8 mL/cmH O)
2 2
<2.8 mL/mbar
O) (<2.8 mL/cmH O)
2 2
<50 mL/min