Technical Data - Dräger Vent Set Basic Gebrauchsanweisung

Instructions for use Vent Set Basic / Vent Set Flex enUS
Vent Set Basic / Vent Set Flex
Disposable Breathing Circuit
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 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 inconven-
ience 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 patient. Intended for single use only.
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.
NOTE
Select the appropriate breathing circuit according to the patient. Higher
resistance or compliance values might lead to an improper ventilation
and possible injury of the patient.
Overview
A B
A B
A Device-side connectors
B Breathing hoses (inspiratory and expiratory)
C Y-piece with elbow and Luer Lock
Instructions for use Vent Set Basic / Vent Set Flex
English / English US
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.
Before the selftest pull extendable hoses out to the desired
length. Otherwise, incorrect compliance values are determined.
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 % 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.
C Any other use of the Luer Lock connector may endanger the pa-
tient.
MP00300
NOTE
When not in use, the Luer Lock connector must be sealed with its cap.
Cleaning and disposal
C
The user is responsible for regularly replacing the medical device accord-
MP00305
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

Keep away from sunlight
Breathing hose length
Consult instructions for
Breathing circuit volume
use
Material
Storage temperature
Breathing hoses
limitation
Y-piece
Performance data
Do not open with knife
Insp./exp. resistance at 60 L/min
Insp./exp. resistance at 30 L/min
Relative humidity
Insp./exp. resistance at 15 L/min
Insp./exp. resistance at 5 L/min
Do not use with oil and
Insp./exp. resistance at 2.5 L/min
grease
Insp. flow rate at 2 mbar
Compliance at 30 mbar and
Non-sterile
NON 60 mbar (at maximal length)
STERILE
Leakage at 60 mbar
REF Part number
Ambient conditions
During storage
LOT Lot number
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
Nomenclature 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
2) 1 mbar = 1
Order list
Designation
Vent Set Basic
Vent Set Flex
Additional items according to Dräger accessories cata-
log
English / English US
MP00300 MP00305
1.5 m (59 in) 0.5 to 1.80 m
(20 to 71 in)
1,1 L 1,4 L
EVA PP
PP PP
1) 2)
<1.8 mbar <3 mbar
<0.5 mbar <0.7 mbar
<0.2 mbar <0.2 mbar
<0.1 mbar <0.1 mbar
<0.1 mbar <0.1 mbar
<65 L/min <45 L/min
<2.4 mL/mbar <1.4 mL/mbar
(<2.4 mL/cmH O) (<1.4 mL/cmH
2
<50 mL/min
–10 to 60 °C (14 to 140 °F)
10 % to 90 % (non-condensing)
800 to 1200 hPa (11.6 to 17.4 psi)
10 to 40 °C (50 to 104 °F)
10 % to 90 % (non-condensing)
800 to 1200 hPa (11.6 to 17.4 psi)
Class IIa
14-238
I, Type BF
cmH O
2
Order No.
MP00300
MP00305
O)
2
3