Technical Data - Dräger Infinity ID Breathing Circuit Smoothbore 150 Gebrauchsanweisung

English / English US
Instructions for use Infinity ID Smoothbore en / enUS English / English US
Infinity ID breathing circuit Smoothbore 150
Infinity ID breathing circuit Smoothbore 300
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 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 inconvenien-
ce 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 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.
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 there-
fore be kept in a location accessible for users.
CAUTION
To prevent damage
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 respiratory gases between an anesthesia
machine or ventilator and an adult patient. Intended for single-use only.
4
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.
WARNING
Select the appropriate breathing circuit according to the patient.
Higher resistance or compliance values might lead to an improp-
er ventilation and possible injury of the patient.
Overview
A B
A Device-side connectors
B Breathing hoses (inspiratory and expiratory hose)
C Y-piece
D Elbow with Luer Lock
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
Use by Non-sterile
NON
STERILE
REF
Date of manufacture Part number
LOT
Manufacturer Lot number
Quantity Output
The product is a medical
MD
device (CE conformity as-
sessment 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 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 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
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 % 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 pa-
tient.
NOTE
When not in use, the Luer Lock connector must be sealed with its cap.
C D
NOTE
This medical device has been designed, tested, and manufactured for
single use and a maximum period of use of 7 days.
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 single use. The medical device must not be
reused, reprocessed, or sterilized.
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

Breathing hose length
Breathing circuit volume
Inspiratory hose volume
Material
Breathing hoses
Connectors
Y-piece
Elbow
Performance data
Insp./exp. resistance at 90 L/min
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 60 mbar
Compliance at 30 mbar
Leakage at 60 mbar
Ambient conditions
During storage
Temperature
Relative humidity
Ambient pressure
During operation
Temperature
Relative humidity
Ambient pressure
Classification Medical Device
Europe
); flush
2
MP04803 MP04804
1.5 m (59 in) 3.0 m (118 in)
1.1 L 2.3 L
0.55 L 1.15 L
EVA EVA
PP PP
PP PP
PP PP
1)
<5 mbar <5.1 mbar
(<5 cmH O) (<5.1 cmH O)
2 2
<2.3 mbar <2.3 mbar
(<2.3 cmH O) (<2.3 cmH O)
2 2
<0.6 mbar <0.6 mbar
(<0.6 cmH O) (<0.6 cmH O)
2 2
<0.2 mbar <0.2 mbar
(<0.2 cmH O) (<0.2 cmH O)
2 2
<0.1 mbar <0.1 mbar
(<0.1 cmH O) (<0.1 cmH O)
2 2
<0.1 mbar <0.1 mbar
(<0.1 cmH O) (<0.1 cmH O)
2 2
<1.3 mL/mbar <2.6 mL/mbar
(<1.3 mL/cmH O) (<2.6 mL/cmH O)
2 2
<1.4 mL/mbar <2.6 mL/mbar
(<1.4 mL/cmH O) (<2.6 mL/cmH O)
2 2
<50 mL/min <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)
10 to 40 °C (50 to 104 °F)
5 % to 95 % (non-condensing)
500 to 1200 hPa (7.3 psi to 17.4 psi)
Class IIa
Instructions for use Infinity ID Smoothbore