Dräger VentStar Basic (P) 180, Инструкция по эксплуатации, Страница: 3 / 32

Instructions for Use VentStar Basic (P) 180/250 3
English / English US
Instructions for Use VentStar Basic (P) 250 en / enUS English / English US
VentStar Basic (P) 180/250
Disposable Breathing Circuit
Trademarks
– VentStar
®
is a trademark owned by Dräger.
Safety information definitions
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
Intended use
Breathing circuit for conduction of respiratory gases between anesthesia
machine or ventilator and pediatric patient. Intended for single-use only.
VentStar Basic (P) 180 is tested for system compatibility and released for
use with specific basic devices, e.g., Evita Infinity V500.
VentStar Basic (P) 250 is tested for system compatibility and released for
use with specific basic devices, e.g., Evita XL.
For further information on system compatibilities, see the lists of acces-
sories of the basic devices or other documents issued by Dräger.
Overview
A Device-side connectors
B Breathing hoses (inspiratory and expiratory hose)
C Patient-side connectors
D Y-piece
E Elbow with Luer Lock
Symbols
Operation
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.
Technical data
Order list
Bestellliste
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.
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
No modification of the medical device is allowed. Modification
may damage or impair the proper functioning of the device which
may lead to patient 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.
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.
NOTE
The circuit diameter of 15 mm (0.59 inches) is specially designed for
pediatric patients.
Pediatric - pertaining to an individual weighing from 5 through 40 kg
(11 lbs and 88 lbs).
001
Not made with natural rub-
ber latex
Keep away from sunlight
Caution
Consult instructions for
use
Do not reuse
Storage temperature
limitation
Do not use if package is
damaged
Do not open with knife
Atmospheric pressure Relative humidity
Use by
Do not use with oil and
grease
Date of manufacture Non-sterile
Manufacturer Part number
Quantity Lot number
Output
For USA:
Rx only Caution: Federal law restricts this device to sale by or on the
order of a physician.
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 % 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.
A C
B
D E
LATEX
NON
STERILE
REF
LOT
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.
MP00351 MP00352
Breathing hose length 1.80 m
(70 inches) 2.50 m
(98 inches)
Breathing circuit volume 0.7 L 1 L
Material
Breathing hoses PE
Connectors PP/EVA
Y-piece PP
Elbow connector/Luer Lock cap PP/TPE
Performance data
Insp./exp. resistance at 60 L/min <3.4 mbar
1)
(<3.4 cmH
2
O)
1) 1 bar = 1 kPa x 100
3.9 mbar
(3.9 cmH
2
O)
Insp./exp. resistance at 30 L/min <0.9 mbar
(<0.9 cmH
2
O)
<1 mbar
(<1 cmH
2
O)
Insp./exp. resistance at 15 L/min <0.3 mbar
(<0.3 cmH
2
O)
<0.3 mbar
(<0.3 cmH
2
O)
Insp./exp. resistance at 5 L/min <0.1 mbar
(<0.1 cmH
2
O)
<0.1 mbar
(<0.1 cmH
2
O)
Insp./exp. resistance at 2.5 L/min <0.1 mbar
(<0.1 cmH
2
O)
<0.1 mbar
(<0.1 cmH
2
O)
Compliance at 30 mbar and
60 mbar <0.9 mL/mbar
(<0.9 mL/cmH
2
O)
<1.1 mL/mbar
(<1.1 mL/cmH
2
O)
Leakage at 60 mbar <50 mL/min
Ambient conditions
During storage
Temperature –20 °C to 60 °C (–4 °F to 140 °F)
Humidity 5 % to 95 % (non-condensing)
Atmospheric pressure 500 hPa to 1200 hPa (7.3 psi to 17.4
psi)
During operation
Temperature 5 °C to 40 °C (41 °F to 104 °F)
Humidity 5 % to 95 % (non-condensing)
Atmospheric pressure 500 to 1200 hPa (7.3 psi to 17.4 psi)
Classification according to EC
Directive 93/42/EEC
Appendix IX
Class IIa
UMDNS code
Universal Medical Device Nomen-
clature System –
nomenclature for medical devices
14-238
Protection class I, Typ BF
The medical device meets the requirements of the ISO 80601-2-13 stan-
dard.
Designation Order No.
For pediatric use:
VentStar Basic (P) 180 with Luer Lock MP00351
VentStar Basic (P) 250 with Luer Lock MP00352
Additional items according to Dräger accessories
catalog