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Instructions for use VentStar Helix heated (N) / dual heated (N) en
VentStar Helix heated (N) Plus / VentStar Helix dual heated (N) Plus
Trademarks
Trademarks owned by Dräger
Trademark
®
VentStar
®
Evita
®
Babylog
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
potentially 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 inconve-
nience 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.
Symbols and abbreviations
Additional information about the symbols is available on the following
web page: www.draeger.com/symbols
Not made with natural rub-
LATEX
ber latex
Caution
Do not reuse
Do not use if package is
damaged
Ambient pressure
Use by
For neonates
REF
Date of manufacture
LOT
Manufacturer
2
High-density polyethylene
PE-HD
The product is a medical
MD
device (CE conformity as-
sessment procedure)
N
Neonatal
ID
Inner diameter
OD
Outer diameter
Instructions for use VentStar Helix heated (N) / dual heated (N)
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
The medical devices are not available individually. Only one copy
of the instructions for use is included in the clinical package and
must therefore be kept in a location accessible for users.
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.
WARNING
Risk of incorrect use
Installation of the breathing circuit to the main device must be in
accordance with the instructions for use of the MR850 humidifer
by Fisher & Paykel and of the main device on which this breath-
ing circuit is used.
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.
NOTE
When connecting or disconnecting breathing hoses, always grip the
sleeve, not the spiral reinforcement. Otherwise, the breathing hose may
be overstretched and damaged.
Keep away from sun-
light
Mandatory reporting of adverse events
Consult instructions
for use
Serious adverse events with this product must be reported to Dräger and
the responsible authorities.
Temperature limitation
Intended use
VentStar Helix dual heated (N) Plus (MP02650): Inspiratory and expirato-
ry heated disposable breathing circuit with humidifier chamber for con-
Do not open with knife
nection to a humidifier MR850 by Fisher & Paykel, for neonatal patients
with a tidal volume of up to 100 mL, for conducting humidified breathing
gas from humidifier to patient.
Relative humidity
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable
breathing circuit with humidifier chamber for connection to a humidifier
MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up
Output
to 100 mL, for conducting humidified breathing gas from humidifier to pa-
tient.
System compatibility
Quantity
The breathing circuits are tested for system compatibility and released for
use with specific main devices, e.g., Babylog VN-Series ventilators.
For further information on system compatibilities, see the lists of acces-
Part number
sories of the main devices or other documents issued by Dräger.
Contraindications
Lot number
There are no known conditions that are a contraindication to the use of
the device.
Keep away from rain
Patient target groups
The patient target groups of the connected main device apply to this prod-
uct. They are listed in the instructions for use for the main device.
The breathing circuit is suitable for high frequency oscillatory ventilation
for a patient weight of up to 8 kg.
Environments of use
The device is intended for stationary use in hospitals and medical rooms
or for intrahospital patient transport.
Do not use the device in the following environments of use:
–
Magnetic resonance imaging
–
During electrocautery
Conditions of use
When conduction of respiratory gases between a ventilation device (e.g.,
critical care ventilator) and a patient interface (e.g., endotracheal tube,
tracheostomy cannula, larynx mask, NIV mask) is required there are no
alternatives to the use of breathing circuits. The indication for a specific
breathing circuit in the individual patient is made by the clinician at his/her
sole discretion based, among other aspects, on the presentation of the
patient, the specific diagnosis/es, diagnostic findings, pathophysiologic
reasoning, technical requirements, and personal experience.
English
Overview
VentStar Helix dual heated (N) Plus (MP02650)
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