Dräger VentStar Helix heated Gebrauchsanweisung Seite 5

Instructions for use VentStar Helix heated (N) / dual heated (N) de
VentStar Helix heated (N) / VentStar Helix dual heated (N)
Trademarks owned by Dräger
The trademarks are registered in the following countries:
Trademark Country
®
VentStar European Union, USA
®
Evita Brazil, Germany, European Union,
France, UK, Sweden, USA
®
Babylog Brazil, Germany, France, UK, USA
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.
Target group
Duties of the operating organization
The tasks described in this document specify the requirements that have
to be met by each respective target group.
The operating organization of this product must ensure the following:
– The target group has the required qualifications (e.g., has undergone
specialist training or acquired specialist knowledge through experi-
ence).
– The target group has been trained to perform the task.
– The target group has read and understood the chapters required to
perform the task.
Description of target groups
The target groups may only perform the following tasks if they meet the
corresponding requirements.
Users
Task Requirement
Use of the product in accor- Specialist medical knowledge in the
dance with the intended use use 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 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.
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.
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
Do not modify the medical device. Modification may damage or
impair the proper functioning of the device which may lead to pa-
tient injury.
Intended use
VentStar Helix dual heated (N) Plus (MP02650): Inspiratory and expirato-
ry heated disposable breathing circuit with humidifier chamber for con-
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.
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
to 100 mL, for conducting humidified breathing gas from humidifier to pa-
tient.
The medical devices are tested for system compatibility and released for
use with specific basic devices, e.g., Babylog VN500.
For further information on system compatibilities, see the lists of acces-
sories of the basic devices or other documents issued by Dräger.
Symbols and abbreviations
Not made with natural rub-
LATEX
ber latex
Caution
Do not reuse
Instructions for use VentStar Helix heated (N) / dual heated (N)
Do not use if package is
damaged
Atmospheric pressure
Use by
For neonates
Date of manufacture
Manufacturer
2
High-density polyethylene
PE-HD
For USA: Caution: Federal law restricts this device to sale by or on the
Rx only order of a physician.
(N) Neonatal
ID Inner diameter
OD Outer diameter
Overview
VentStar Helix dual heated (N) Plus (MP02650)
O
F
E
D
L
C
D
E
L
I
Keep away from sun-
light
Consult instructions
for use
Temperature limitation
English / English US
Do not open with knife
Relative humidity
Non-sterile
NON
STERILE
Quantity
REF
Part number
LOT
Lot number
Keep away from rain
K
N
O
I
A
B
M
J
P
G
O
O
K
F
A
N
C
M
B
J
G
H
P
VentStar Helix heated (N) Plus (MP02608)
O
F
R
Q
D
L
O
I
A
B
C
M
J
P
D
O
F
Q
L
I
R
M
C
J
G
H
P
The breathing circuit consists of:
A Device-side connector of inspiratory hose
B Connection hose for humidifier chamber (blue)
C Heated inspiratory hose (blue)
D Y-piece (patient-side connector)
E Heated expiratory hose (white)
F Device-side connector of expiratory hose
G Humidifier chamber for neonates (VentStar Neo) with blue floater for
automatic closure of the water supply
H Maximum water level indicator
I Patient-side temperature sensor
J Humidifier-side temperature sensor
K Supply container (not part of the breathing circuit)
L Hose extension for use in the incubator (blue)
M Connector for inspiratory hose heater
N Connector for expiratory hose heater
O Device-side double connector (MP02655) for connecting ventilators
(not included with MP02650 and MP02608)
When using MP02650 or MP02608 the connector is required for all
Dräger ventilators released for use with this medical device except for
Babylog devices.
P Connector for inspiratory hose (for connecting the humidifer-side
temperature sensor)
Q Expiratory hose with water trap
R Water trap
English / English US
K
G
O
K
A
B
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