Dräger VentStar Oxylog VE300 Instrucciones De Uso página 3

Instructions for use VentStar Oxylog VE300 en / enUS English / English US
VentStar Oxylog VE300
Disposable Breathing Circuit
Trademarks
Trademarks owned by Dräger
Trademark
®
VentStar
®
Oxylog
The following web page provides a list of the countries in which the
trademarks 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 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 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
product.
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 product 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. Remove the red protection cap,
if available, only shortly before use. Do not use the medical de-
vice 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 functional integrity of the device which
may lead to patient injury.
WARNING
Risk of malfunction
Obstructions, damage, and foreign matter can lead to malfunc-
tion.
Check all system components for obstructions, damage, and
foreign 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
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.
Instructions for use VentStar Oxylog VE300
Intended use
Disposable breathing circuit with integrated expiratory valve and pres-
sure sensor for conduction of medical gases between emergency and
transport ventilators Oxylog VE300 (without Option Plus) and patient, for
adult patients with a tidal volume from 100 mL upwards. Intended for
single use only.
Environments of use:
– Mobile use for emergency patients, for outdoor and indoor environ-
ments
– During transport in ambulances, airplanes, helicopters, and on board
ships
– In accident and emergency departments
– During intrahospital transport of ventilated patients
Overview
B C
D
A
A Red protection cap
B Elbow
C Breathing valve
D Breathing hose
E Device-side connectors
Symbols
Additional information about the symbols is available on the following
web page: www.draeger.com/symbols
Not made with natural rub-
Keep away from sunlight
LATEX
ber latex
Consult instructions for
Caution
use
Do not reuse Storage temperature
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
Manufacturer Part number
REF
LOT
Quantity Lot number
The product is a medical
MD device (CE conformity
Direction of flow
assessment procedure)
For USA: Caution: Federal law restricts this device to sale by or on the
Rx only order of a physician.
Preparation
Connecting the disposable breathing circuit
NOTE
Disposable hoses are shipped clean but non-sterile.
B
A
1 Connect the breathing hose (A) to the expiratory port on the device.
2 Connect the pressure measuring line (B) to the connector on the de-
vice.
Function test in accordance with instructions for use of the basic device.
Operation
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.
WARNING
Confirm that all connections are secure and free of leakages.
Comply with the instructions for use of basic device.
WARNING
Risk of patient injury
Adding further components and using incompatible components
may increase inspiratory resistance, expiratory resistance, and
dead space and adversely affect the performance of the ventila-
tor.
WARNING
Risk of fire
When administering oxygen, keep open flames, sparks, or other
possible ignition sources away from the device.
Cleaning and disposal
The user is responsible for regularly replacing the medical device accord-
ing to the hygiene regulations.
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.
CAUTION
Reuse, reprocessing, or sterilization can lead to failure of the medical
E
device and cause injury to the patient.
This medical device has been designed, tested, and manufactured ex-
clusively for single use. The medical device must not be reused, repro-
cessed, or sterilized.
Technical data
MP01370
Breathing hose length 1.8 m (70 in)
Material
Breathing hose PE
Expiratory valve PP, VMQ, TPE
Red protection cap PE
Connectors PP, PVC
Performance data
Insp. resistance at 60 L/min <4.3 mbar
(<4.3 cmH
Insp. resistance at 30 L/min <1.6 mbar
(<1.6 cmH
Insp. resistance at 15 L/min <0.7 mbar
(<0.7 cmH
Exp. resistance at 60 L/min <4 mbar (<4 cmH
Exp. resistance at 30 L/min <2.1 mbar
(<2.1 cmH
Exp. resistance at 15 L/min <1.5 mbar
(<1.5 cmH
Compliance at 30 mbar <1 mL/mbar
(<1 mL/cmH
Compliance at 60 mbar <1.3 mL/mbar
(<1.3 mL/cmH
Leakage at 60 mbar <50 mL/min
Insp. rated flow at 2 mbar 36 L/min
Exp. rated flow at 2 mbar 30 L/min
Dead space <30 mL
Ambient conditions
During storage
Temperature –20 to 50 °C (–4 to 122 °F)
Humidity 5 to 95 % (non-condensing)
Ambient pressure 570 to 1200 hPa (8.3 to 17.4 psi)
During operation
Temperature –20 to 50 °C (–4 to 122 °F)
Humidity 5 to 95 % (non-condensing)
Ambient pressure 570 to 1200 hPa (8.3 to 17.4 psi)
Classification Class IIb
Medical Device Europe
UMDNS code 14-238
Universal Medical Device
Nomenclature System –
nomenclature for medical
devices
Protection class Type BF
1) 1 bar = 1 kPa x 100
Order list
Designation
VentStar Oxylog VE300, 150
VentStar Oxylog VE300, 300
Additional items according to Dräger accessories
catalog
English / English US
MP01371
3.3 m (130 in)
1)
<4.7 mbar
O) (<4.7 cmH O)
2 2
<1.8 mbar
O) (<1.8 cmH O)
2 2
<0.75 mbar
O) (<0.75 cmH O)
2 2
O) <4 mbar (<4 cmH O)
2 2
<2.1 mbar
O) (<2.1 cmH O)
2 2
<1.5 mbar
O) (<1.5 cmH O)
2 2
<1.6 mL/mbar
O) (<1.6 mL/cmH O)
2 2
<1.8 mL/mbar
O) (<1.8 mL/cmH O)
2 2
<50 mL/min
33 L/min
30 L/min
<30 mL
Order No.
MP01370
MP01371
3