Werbung
Verfügbare Sprachen
Verfügbare Sprachen
Instructions for use VentStar MRI 300 enUS
VentStar MRI 300
Disposable breathing circuit
Trademarks
Trademarks owned by Dräger
Trademark
®
VentStar
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 se-
cure.
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 breathing gases between an anesthesia
machine or ventilator and an adult patient. Intended for single-use only.
Suited for MRI applications.
Instructions for use VentStar MRI 300
English / English US
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.
WARNING
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 Device-side connectors
B Breathing hoses (inspiratory and expiratory hose)
C Elbow with Luer Lock
Symbols
Not made with natural rub-
LATEX
ber latex
Caution
Do not reuse
Do not use if package is
damaged
Ambient pressure
Use by
STERILE
Date of manufacture
REF
Manufacturer
LOT
Quantity
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.
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.
C
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.
Keep away from sunlight
Technical data
Consult instructions for
use
Breathing hose length
Storage temperature
Breathing circuit volume
limitation
Inspiratory hose volume
Do not open with knife
Material
Breathing hoses
Relative humidity
Y-piece
Connectors
Non-sterile
NON
Cap for Luer Lock
Performance data
Part number
Insp./exp. resistance at 90 L/min
Lot number
Insp./exp. resistance at 60 L/min
Insp./exp. resistance at 30 L/min
Output
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
UMDNS code
Universal medical device Nomencla-
ture 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
VentStar MRI 300
Additional items according to Dräger accessories
catalog
); flush
2
English / English US
3 m (118 in)
2.3 L
1.15 L
EVA
PP
PP
PE
1)
<5.1 mbar
(<5.1 cmH
O)
2
<2.3 mbar (<2.3 cmH
O)
2
<0.6 mbar (<0.6 cmH
O)
2
<0.2 mbar (<0.2 cmH
O)
2
<0.1 mbar (<0.1 cmH
O)
2
<0.1 mbar (<0.1 cmH
O)
2
<2.6 mL/mbar
(<2.6 mL/cmH
O)
2
<2.6 mL/mbar
(<2.6 mL/cmH
O)
2
<50 mL/min
–20 to 60 °C (–4 to 140 °F)
5 % to 95 % (non-condensing)
570 hPa to 1200 hPa (8.2 psi to
17.4 psi)
10 to 40 °C (50 to 104 °F)
5 % to 95 % (non-condensing)
570 hPa to 1200 hPa
(8.2 psi to 17.4 psi)
Class IIa
14-238
Type BF
Order No.
MP04800
3
Werbung
