Dräger VentStar Helix heated Notice D'utilisation page 4

English / English US
Instructions for use VentStar Helix heated / VentStar Helix dual heated de
VentStar Helix heated / VentStar Helix dual heated
Disposable breathing circuit
Trademarks
Trademarks owned by Dräger
Trademark
®
VentStar
®
Evita
®
Infinity
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-
Keep away from sunlight
LATEX
ber latex
Consult instructions for
Caution
use
Do not reuse Temperature limitation
Do not use if package is
Do not open with knife
damaged
Ambient pressure Relative humidity
Use by Non-sterile
NON
STERILE
Keep free of oil and grease Quantity
Date of manufacture REF Part number
Manufacturer LOT Lot number
The product is a medical
MD
Keep away from rain device (CE conformity
assessment procedure)
For USA: Caution: Federal law restricts this device to sale by or on the
Rx only order of a physician.
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
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.
4
English / English US
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
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.
NOTE
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
VentStar Helix dual heated MP02606: Inspiratory and expiratory heated
disposable breathing circuit with humidifier chamber for connection to a
humidifier MR850 by Fisher & Paykel, for pediatric and adult patients with
a tidal volume of at least 100 mL, for conducting humidified breathing gas
from humidifier to patient.
VentStar Helix heated MP02607: Inspiratory heated disposable breathing
circuit with humidifier chamber for connection to a humidifier MR850 by
Fisher & Paykel, for pediatric and adult patients with a tidal volume of at
least 100 mL, for conducting humidified breathing gas from humidifier to
patient.
The medical device is tested for system compatibility and released for
use with specific main devices, e.g., Evita Infinity V500. For further infor-
mation on system compatibilities, see the lists of accessories of the main
devices or other documents issued by Dräger.
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.
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:
– Hyperbaric chambers
– Magnetic resonance imaging
– During diathermy
– During electrocautery
– Together with flammable gases or flammable solutions that can mix
with air, oxygen, or nitrous oxide
– Areas with danger of explosion
– Areas with combustible and highly flammable substances
– Rooms with insufficient ventilation
Do not operate the device with helium or helium mixtures.
Overview
MP02606
C
D
E
MP02607
C
D
E E
B
Preparation and installation
VentStar Helix heated (MP02607)
E
D
G
C
VentStar Helix dual heated (MP02606)
E
D
G
C
The breathing circuit consists of:
A Connection hose for humidifier chamber (blue)
B Water trap (only for MP02607)
C Inspiratory hose heated (blue)
D Y-piece
E Expiratory hose (white), only for MP02606 heated
F Humidifier chamber
Additional accessories:
G Temperature sensor patient-side
A
H Temperature sensor humidifier-side
I Supply container (not part of the breathing circuit)
WARNING
F
Risk of patient injury
When installing the breathing circuit, make sure not to mix up the
inspiratory hose and the expiratory hose. Note the illustration in
the chapter "Overview": The temperature sensors are in the in-
spiratory limb.
A
WARNING
Risk of patient injury
Make sure to install the breathing circuit without loops and kinks
F
as they may increase resistance.
WARNING
Risk of patient injury
Only use distilled water. The use of other substances can harm
the patient.
WARNING
Before putting the breathing circuit into operation, the humidifier
chamber must be filled with sterile distilled water and check func-
tion of floater.
Check that the maximum water level is not exceeded so that wa-
ter cannot enter the breathing circuit.
WARNING
Risk of patient injury
If the humidifier chamber is positioned too high in the breathing
circuit, water may enter the breathing hoses.
The humidifier chamber must be positioned lower than the pa-
tient.
Instructions for use VentStar Helix heated / VentStar Helix dual heated
I
E
B
A
H
F
MR850
I
A
H
F
MR850