Dräger VentStar Aquapor heated A/P Instrucciones De Uso página 4

English / English US
Instructions for use VentStar Aquapor heated A/P / VentStar Aquapor dual heated A/P de
VentStar Aquapor heated A/P / VentStar Aquapor dual heated A/P
Disposable breathing circuit
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
experience).
– 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.
Symbols and abbreviations
Additional information about the symbols is available on the following
webpage: 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 Keep away from rain
Date of manufacture Quantity
Manufacturer REF Part number
The product is a medical
MD
device (CE conformity Lot number
LOT
assessment procedure)
A/P Adult / Pediatric
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
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.
4
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 patient injury
Nebulize only water-based drugs.
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.
Intended use
VentStar Aquapor dual heated A/P (MP07130)
Inspiratory and expiratory heated disposable breathing circuit with hu-
midifier chamber for connection to a Dräger Aquapor H300 humidifier, for
conducting humidified breathing gas from humidifier to patient, for pedi-
atric and adult patients with a tidal volume of at least 100 mL.
VentStar Aquapor heated A/P (MP07131)
Inspiratory heated disposable breathing circuit with humidifier chamber
for connection to a Dräger Aquapor H300 humidifier, for conducting hu-
midified breathing gas from humidifier to patient, for pediatric and adult
patients with a tidal volume of at least 100 mL.
System compatibility
The breathing circuits are 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.
Patient target groups
The patient target groups of the connected main device apply to this
product. 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
MP07130
C
D
E
MP07131
C
D
E E
B
English / English US
Installation and operation
VentStar Aquapor dual heated A/P (MP07130)
E
D
G
C
VentStar Aquapor heated A/P (MP07131)
E
D
G
C
The breathing circuit consists of:
A Connection hose for humidifier chamber (blue)
B Water trap (only for MP07131)
C Inspiratory hose heated (blue)
D Y-piece
E Expiratory hose (white), only for MP07130 heated
F Humidifier chamber
Additional accessories:
G Temperature sensor patient-side
H Temperature sensor humidifier-side
I Supply container (not part of the breathing circuit)
WARNING
Risk of patient injury
A
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.
F
WARNING
Risk of misuse
Installation of the breathing circuit to the basic device must be in
accordance with the instructions for use of the humidifer
Aquapor H300 and of the basic device on which this breathing
A
circuit is used.
WARNING
Risk of patient injury
F
Only use sterile 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 Aquapor heated A/P / VentStar Aquapor dual heated A/P
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